AI-powered quality and compliance for manufacturing, clinical, pharmacovigilance, laboratory, and distribution. Every AI output passes through a human decision gate. Every action audit-trailed.
Compliance that scales with your business without scaling your risk.
Verixa cuts deviation-to-closure timelines by 40%. AI-assisted root cause analysis and recommendation engine accelerate investigation and CAPA closure.
Example: Manufacturing deviation resolved from 45 days to 27 days.
Platform consolidation eliminates point-tool sprawl. One audit trail, one vendor, one data model across all GxP domains.
Typical savings: 50% reduction in tool licensing and integration overhead.
Hash-chain audit trail with immutable 15-field entries. 21 CFR Part 11 e-signature architecture. Real-time GxP context validation.
Zero audit findings on data integrity frameworks in 8 beta deployments.
54 Quality Modules. 209+ Data Points Tracked. 155+ Workflow Routes. 100% Audited.
Full lifecycle from creation through closure. HITL approval gates at risk assessment and RCA sign-off. Auto-linkage to batch, product, equipment. 95% built.
Kanban workflow. AI-assisted recommendation engine. Effectiveness tracking at 30/60/90 days. SLA enforcement with escalation. 95% built.
Five proven methods: Fishbone, 5-Why, Fault Tree, Dynamic Reasoning, AI-assisted pattern matching. Each step audit-trailed. 85% built.
5×5 RPN matrix with customizable scales. FMEA integration. Trend analysis across batches and suppliers. Risk-based prioritization. 90% built.
Impact assessment matrix. Approval workflows. Version tracking. Implementation verification. Regulatory impact documentation. 80% built.
4-tier libraries (corporate, site, department, user). Versioning with change history. Lifecycle management. Distribution & acknowledgment tracking. 90% built.
SHA-256 hash chain. 15 fields per entry (timestamp, user, action, object, change, rationale, domain, IP, session, etc.). 21 CFR Part 11 compliant. 95% built.
Drag-and-drop approval chains. Conditional routing. SLA enforcement. HITL decision gates. Integration with external approvers. 85% built.
Compliance KPIs, deviation trends, CAPA effectiveness, risk analytics. SPC control charting (Nelson/Western Electric rules). Regulatory-ready exports. 85% built.
AI-assisted workflows that strengthen judgment, never replace it.
Ask questions in plain English. MIRA translates to SQL, retrieves context, and surfaces insights. Every AI call logged in audit trail. No SQL knowledge required. 90% built.
AI-assisted classification of incoming deviations based on regulatory framework. Human reviews and approves before routing. Full HITL traceability. 90% built.
RAG-powered guidance on 21 CFR, ICH E6, EU GMP, WHO guidelines. MIRA cites regulation, applies to your context. Every citation auditable. 90% built.
Conversational interface for RCA suggestions, CAPA recommendations, and risk assessment support. All suggestions logged and require human sign-off. 85% built.
Every critical decision passes through human judgment.
System detects deviation, calculates risk, recommends RCA method or CAPA action. All based on historical precedent and regulatory context.
QA Manager, Quality Lead, or Domain Expert reviews suggestion in HITL gate. Can accept, modify, or reject. Rationale logged.
Decision recorded with timestamp, actor, decision type, and rationale. Linked to AI suggestion for traceability.
Complete chain visible to auditor: suggestion → human review → decision → action → outcome. Hash-chain immutable record.
One platform, five specialized domain modules.
Batch record deviations, equipment qualification, supplier management, environmental monitoring.
Key capabilities: OOS investigation, batch disposition, CAPA effectiveness, equipment lifecycle.
Protocol deviations, TMF completeness, site monitoring, ALCOA+ data integrity.
Key capabilities: Deviation tracking, IRB notification, sponsor reporting, monitoring visit prep.
ICSR processing, causality assessment, signal detection, PSUR/PBRER management.
Key capabilities: MedDRA coding, SUSAR reporting, benefit-risk assessment, PSMF documentation.
Study protocol deviations, raw data integrity, equipment/facility qualification, archive management.
Key capabilities: Study director workflow, QAU inspection, specimen accountability, protocol amendments.
Temperature excursion management, transportation qualification, counterfeit/diversion risk, warehouse qualification.
Key capabilities: Cold chain monitoring, shipment integrity, batch disposition, compliance reporting.
We implement it. We verify it. We support it.
$4,500—$6,000
Expert review of your current QMS, compliance posture, and GxP readiness across one or more domains. 10-day assessment with detailed findings and remediation roadmap.
$15,000—$25,000
Intensive 4-week engagement to close critical compliance gaps before a scheduled inspection. Navira QA brings domain expertise and process rigor.
$12,000—$18,000
Expert CAPA design and implementation for high-risk, cross-functional findings. Includes RCA methodology selection, team facilitation, and effectiveness verification.
Real-time compliance dashboards. Trend detection across domains. Risk-based prioritization. Board-ready metrics and audit readiness forecasting.
Platform consolidation cuts tool costs. One vendor reduces vendor management overhead. Risk mitigation reduces inspection failure costs.
Multi-product, multi-site GxP governance. Client-facing compliance analytics. Rapid onboarding of new products and sites.
Verixa reduces regulatory risk. Data-driven compliance decision-making. Inspection outcome predictability. Valuation-relevant risk management.
| Feature | Verixa | Veeva QualityOne | TrackWise | Qualio | ComplianceQuest |
|---|---|---|---|---|---|
| 5-Domain GxP Coverage | ✓ | Partial | ✓ | Partial | ✓ |
| HITL Governance Gates | ✓ | — | — | — | — |
| AI-Assisted RCA | ✓ | Limited | — | — | — |
| Hash-Chain Audit Trail | ✓ | — | — | — | — |
| Self-Hosted Option | ✓ | — | ✓ | — | ✓ |
| Regulatory Q&A (RAG) | ✓ | — | — | — | — |
| GxP Context Switching | ✓ | — | — | — | — |
Transparency is compliance. Here's what we're building toward.
We won't close CAPAs without human review and sign-off. HITL governance is non-negotiable. We're expanding AI to surface patterns and predict effectiveness, not to remove judgment.
We meet all Part 11 requirements (e-signature, audit trail, access controls). But we haven't sought formal third-party certification yet. It's on the roadmap for 2027.
Today: English and US regulatory focus. We're developing localized versions for EU, APAC, and China—targeting 2027. Localization requires domain expertise and local validation.
Book a 30-minute platform walkthrough tailored to your GxP domain. We'll show you how HITL governance, AI-assisted workflows, and hash-chain audit trails work in practice.
Universal GxP Core. Domain-Specific Intelligence.
28 Safe Public + 14 Qualified Public capabilities. Every feature audit-tested. Full lifecycle support across all GxP domains.
Full lifecycle from creation through closure. Classification with GxP context auto-selection. HITL approval gates. Linkage to risk assessment and CAPA. 95% built.
Effectiveness tracking with 30/60/90-day verification. Kanban workflow. AI-assisted corrective action recommendations. SLA enforcement. 95% built.
Fishbone, 5-Why, Fault Tree analysis, Dynamic Reasoning, AI-assisted pattern matching. Each step audit-trailed. Full traceability to deviation. 85% built.
5×5 RPN matrix with customizable scales. FMEA integration. Trend analysis across batches/suppliers. RPN scoring: 90% built.
Impact assessment matrix. Approval workflows with versioning. Implementation verification. Regulatory impact documentation. 80% built (qualifier: field-validation needed).
Auto-linkage and traceability across all three phases. One audit trail. Dashboard for monitoring workflow progress. 90% built.
SHA-256 hash chain, 21 CFR Part 11 compliant. 15 fields per entry. Four views: timeline, user, object, pattern-based. 95% built.
9 signature meanings: Author, Reviewer, Approver, Risk Assessor, RCA Investigator, CAPA Owner, QA Supervisor, QA Manager, Regulatory Affairs. 90% built.
HITL decision gates at risk assessment, RCA, CAPA approval. All human decisions logged with rationale. 85% built.
Drag-and-drop approval chains. Conditional routing. SLA enforcement. Versioning for workflow evolution. 85% built.
TDAL (Tenant Data Access Layer), 3 isolation modes. No data bleed between organizations. 95% built.
Adverse event tracking. Complaint classification. Severity assessment. Linkage to deviation and CAPA. 90% built.
Phase 1 + Phase 2 workflow. Batch impact assessment. Stability data consultation. Disposition decision gates. 90% built.
MBR (Master Batch Record) + execution tracking. Test result linkage. Deviation correlation. Regulatory-ready exports. 87% built.
ICH-compliant study protocols. Time-point data collection. Trend analysis. Shelf-life assessment support. 90% built.
Deviation summary aggregation. CAPA effectiveness review. Regulatory change impact assessment. Trend reporting. 85% built.
Monitoring schedule tracking. Data collection and trending. OOS alert triggers. Correlation with batch issues. 90% built.
Assessment template library. Defect rate tracking. Re-qualification due dates. Audit report management. 85% built.
4-tier libraries (corporate, site, department, user). Version control with change history. Automated lifecycle state management. 90% built.
Multi-reviewer workflows. Conditional approval logic. E-signature with meaning codes. Approval audit trail. 90% built.
IND, CTA, MAA dossier management. Submission status tracking. Regulatory correspondence log. 82% built.
Real-time KPIs: deviation trends, CAPA effectiveness, risk distribution. Regulatory-ready metrics. 85% built.
Nelson and Western Electric rules. Trend detection. Process capability analysis. Out-of-control alerts. 88% built.
Ask in plain English. MIRA translates to SQL. Safety guards prevent injection attacks. Every AI call logged in audit trail. 90% built.
Every MIRA AI call logged with input, output, latency, model version, safety check results. Full traceability. 90% built.
Drag-and-drop workflow design. Conditional logic. Approval routing. Template library. 85% built.
No vendor-hosted data. AWS, Azure, GCP customer accounts. Full data residency control. 95% built.
Batch import/export of deviations, CAPAs, documents. Scheduled bulk actions. Audit-trailed. 85% built.
Email, in-app, SMS alerts for SLA breaches, approvals, escalations. Configurable per role. 87% built.
Pluggable integrations with Veeva, SAP, SharePoint, LabWare, Vault eTMF. REST API for custom integrations. 85% built.
SAML 2.0 and OIDC single sign-on. MFA enrollment (TOTP, WebAuthn). IP allowlisting. Session management with concurrent session limits. Integrates with Okta, Azure AD, Ping.
Designed to track training assignments, completion, competency gaps. Not a full LMS, but integrates with your training platform.
AI-assisted mock drills and scoring. Readiness assessment dashboard. Document completeness checklist.
Conversational interface for guidance. All suggestions require human review and sign-off. Architected for configurable HITL gates.
AI-assisted multi-agent deliberation panel for complex RCAs. Human expert makes final decision.
Compare deviation and CAPA trends across multiple sites. Alert correlation to identify systemic issues.
Integration-ready architecture with connector framework. Pluggable adapters for your legacy systems.
Designed to process scanned documents. OCR processing for historical record digitization.
i18n framework in place. Localization for EU, APAC, China in development. Current: English and US regulatory focus.
Advanced capabilities that set Verixa apart from legacy QMS platforms.
Signal collection across quality data. Z-score analysis and linear regression. Cross-domain correlation to predict deviations before they occur. Risk scoring with explainable drivers.
AI-driven root cause analysis. Automatic evidence gathering from equipment, environment, operator, and supplier context. Guided investigation workflow. Human expert validates and signs off.
Live feed integration with FDA Federal Register, FDA Warning Letters, and EMA publications. Auto-detect regulatory changes that affect your operations. Impact propagation across SOPs, training, and processes.
Full migration pipeline: discovery, field mapping, test migration, hash verification, IQ/OQ/PQ evidence generation, reconciliation, cutover. Move from paper or legacy QMS with validated traceability.
Automated validation protocol execution. Evidence capture with screenshots. Installation, Operational, and Performance Qualification per GAMP 5. Validation package generation for auditor review.
10-section audit package auto-generated from live data. Mock audits with AI-driven findings. Readiness scoring per department. Inspector-ready dossier at the push of a button.
Universal GxP Core adapts to every regulated domain. Activate the pack you need.
Native domain. Batch records, stability, environmental monitoring, APQR, OOS/OOT, supplier qualification. Full lifecycle from raw material to release.
Protocol deviation management. Site monitoring workflows. TMF integration. SAE reporting. Randomization tracking. ICH E6(R2) compliant.
ICSR processing. Signal detection and evaluation. PSUR generation. EudraVigilance and FAERS submission. Benefit-risk assessment. EU PV legislation compliant.
Study director workflows. QAU inspection management. Test facility oversight. Protocol deviation tracking. Specimen chain of custody. OECD GLP compliant.
Cold chain monitoring. Transport qualification. Lane risk assessment. Distribution chain tracking. Temperature excursion management. EU GDP compliant.
Statistical analysis plan management. CDISC data standards (SDTM, ADaM). Unblinding workflows. Randomization list management. Clinical data integrity.
MSL activity tracking. KOL management. Medical information request handling. Publication planning. Congress management. Scientific communication compliance.
Select your domain once. Verixa adapts fields, workflows, and regulatory references.
When you create a deviation, CAPA, or training record, you select the GxP domain (GMP, GCP, GVP, GLP, GDP). Verixa instantly configures:
One platform. No separate instances for GMP vs GCP vs GVP. Users switch domains mid-session without context loss. Audit trail automatically tags entries with domain for cross-domain analytics.
Result: 60% faster onboarding of multi-domain organizations.
AI that strengthens judgment, not replaces it.
Natural-Language Query Engine
Ask questions in plain English: "Which deviations in manufacturing happened in the last 30 days with batch impact?" MIRA translates to SQL, retrieves context, and returns structured results with citations.
Zero SQL knowledge required. Works across all domains and data models.
Predictive Risk Assessment
ML model predicts deviation likelihood for batches, sites, products, and suppliers. Trained on 10+ years of GxP data. Surfaces high-risk batches before production release.
Example: MIRA flags a supplier with 3x higher defect rate after equipment change—triggering supplier audit.
RAG-Powered Knowledge Engine
Ask about 21 CFR Part 11, ICH E6, EU GMP, WHO GLP guidelines. MIRA retrieves relevant sections, cites the source, and applies the guidance to your context.
Example: "What are the ALCOA+ requirements for laboratory notebooks?" MIRA returns 21 CFR 58.130 excerpt + your lab's implementation status.
Continuous Regulatory Monitoring
Verixa monitors FDA guidance, ICH updates, and regulatory alerts. New guidance is mapped to your GxP domains and surfaced as actionable updates.
Example: FDA releases new CAPA expectations → MIRA flags your organization's open CAPAs that may need adjustment.
Two-component authentication (password + TOTP or hardware key). Digital signature with timestamp. Biometric override capability with audit logging.
1. Author 2. Reviewer 3. Approver 4. Risk Assessor 5. RCA Investigator 6. CAPA Owner 7. QA Supervisor 8. Quality Assurance Manager 9. Regulatory Affairs.
Meets 21 CFR Part 11 requirements: identification & authentication, audit trail, records retention, system validation, and user access controls. Ready for FDA inspection.
Built on modern, proven technology stack.
See how MIRA AI, HITL governance, and hash-chain audit trails work in your domain.
GMP compliance. Deviation to resolution in days, not weeks.
21 CFR 211.192
CAPAs are approved but effectiveness never verified. Similar deviations recur. Investigator judgment varies. No pattern detection across batches or suppliers.
ALCOA+ & Audit Trail Gaps
Batch records lack complete traceability. Deviations logged after-the-fact. Changes not timestamped. Spreadsheets maintain parallel universe of compliance data.
EU GMP Annex 15
Equipment OOS results not linked to qualification status. Maintenance schedules drift. Performance trend data scattered across equipment files.
21 CFR 211.84
Supplier defect rates not tracked. No systematic re-qualification process. Quality agreements dated but not enforced. Received goods defects not linked back to supplier assessment.
Manufacturing deviation → CAPA closure → Audit ready
Production line operator logs an out-of-specification (OOS) result during batch release testing. Test method: HPLC potency. Result: 98.2% (spec: 99.0—101.0%).
Verixa creates a deviation record with GMP context auto-selected. Fields auto-populated: batch number, product, test method, OOS value, specification limits, responsible analyst, testing date.
QA enters: batch size, number of units distributed, therapeutic indication, safety margin to spec.
Verixa 5×5 RPN matrix scores the deviation: Severity 4 (product safety impact), Likelihood 2 (single test failure), Detection 3 (caught before release) = RPN 24 (moderate).
MIRA AI suggests: "Historical precedent: 4 similar potency deviations in past 24 months. All traced to column degradation. Recommend Ishikawa RCA focused on instrument maintenance."
HITL Gate: QA Manager reviews risk scoring and MIRA suggestion. Approves risk level and RCA method via digital signature. Rationale logged.
Investigator launches Ishikawa fishbone analysis in Verixa. Categories: People, Methods, Materials, Equipment, Environment.
MIRA cross-references: "3 similar potency failures on this HPLC instrument in past 12 months. Last column replacement: 8 months ago. Maintenance schedule recommends every 6 months."
Investigator drills into 5-Why:
Result: Root cause identified in 2 days (normally 5—7 days). Full RCA audit-trailed.
MIRA recommends: "Corrective: Replace HPLC column. Preventive: Revert column maintenance schedule to 6-month cycle. Systemic: Update procurement SOP to flag vendor lead-time changes and trigger maintenance schedule review."
HITL Gate: Quality Lead reviews CAPA recommendation. Modifies preventive action scope to include all HPLC instruments (not just this one). Assigns corrective action to Operations, preventive to Engineering, systemic to Quality.
CAPA created with due dates: Corrective (immediate), Preventive (14 days), Systemic (30 days).
Operations replaces column (1 day). Engineering updates maintenance schedule (3 days). Quality publishes revised procurement SOP (5 days).
CAPA tracked on Kanban board: "In Progress" → "Pending Effectiveness Check" → "Effectiveness Verified".
SLA warnings trigger if any action overdue. Escalation notifies VP Quality.
30-day effectiveness check: QA reviews next 10 batches through same test method on same instrument. All results in spec (99.5%—100.8%). No OOS alerts.
MIRA analyzes: "0 potency failures on this instrument in 30 days (vs. 0.33 failures/month historically). Trend: stable."
QA Manager signs off: "CAPA effective."
Complete chain: Deviation → Risk Assessment → RCA → CAPA → Execution → Effectiveness → Closed.
All steps linked in hash-chain audit trail. Inspector asks: "Show me your OOS handling process." One click. Complete folder: deviation form, risk worksheet, RCA template, 5-Why tree, CAPA plan, execution logs, effectiveness data, digital signatures.
Timeline: Day 0 (deviation) → Day 27 (CAPA closed) → Day 0 of next inspection (ready).
All features below are 80%+ built and audit-validated.
OOS results, environmental deviations, equipment failures, specification failures. Deviation linked to batch, product, manufacturing date. Automatic root cause linkage. 95% built.
Structured two-phase workflow. Batch impact assessment. Historical data trend analysis. Stability implications. Disposition decision with QA approval. 90% built.
Release vs. Quarantine vs. Rework decision gates. Regulatory impact assessment. Stability data consultation. Documentation for regulatory file. 87% built.
IQ/OQ/PQ status tracking. Maintenance schedule enforcement. Performance trend analysis. Re-qualification due date alerts. Deviation correlation with equipment performance. 85% built (qualification: validation protocol may require site input).
Assessment template library. Defect rate monitoring. Re-qualification due dates. Quality agreement tracking. Received goods defect linkage to supplier performance. 85% built.
Monitoring schedule tracking. Temperature, humidity, particle count trending. OOS alert triggers. Correlation with batch production windows and quality failures. 90% built.
30/60/90-day effectiveness tracking. Re-verification workflows. Trend analysis on similar deviations post-CAPA. Regulatory-ready documentation. 95% built.
SHA-256 hash chain for all manufacturing operations. 21 CFR Part 11 compliant. Every step (deviation, risk, RCA, CAPA, execution) audit-trailed. 95% built.
Implementation, readiness, and ongoing support.
$4,500—$6,000
Expert review of your manufacturing QMS against 21 CFR 210/211, EU GMP Annexes, ICH Q7/Q10. Includes deviation management process, CAPA effectiveness, data integrity, and equipment qualification assessment.
$15,000—$25,000
Intensive 4-week engagement to close critical GMP gaps before a scheduled FDA or EMA inspection. Includes deviation backlog review, CAPA effectiveness verification, audit trail remediation, and mock inspection preparation.
$12,000—$18,000
Expert CAPA design for high-risk deviations (equipment failure, data integrity issues, supplier defects). Includes RCA facilitation, preventive/systemic action design, and effectiveness verification protocol development.
FDA Regulations (USA)
cGMP for finished pharmaceuticals. Covers facilities, equipment, materials, production, quality controls, complaint handling, and records.
European Union Guidance
Annexes 1—19 covering sterile products, radiopharmaceuticals, veterinary products, advanced therapy products, and biotechnology products.
Harmonized Guidelines
Q7: Good Manufacturing Practice for APIs. Q9: Quality Risk Management. Q10: Pharmaceutical Quality Systems.
India Manufacturing Standards
Good Manufacturing Practices rules under Drugs and Cosmetics Act, 1940. Applies to drug manufacturers in India.
World Health Organization
Recommendations for GMP in manufacturers of pharmaceutical substances and finished dosage forms for human use.
Biologics & Blood Products
Specific GMP requirements for therapeutic biologics, vaccines, monoclonal antibodies, and blood/blood products.
See how Verixa cuts deviation-to-closure timelines and ensures CAPA effectiveness.
GCP compliance. Protocol deviation management. Audit-ready documentation.
Deviations reported inconsistently. Risk assessment lacks standardization. Sponsor notification timelines unclear. Sites don't track recurrence patterns.
Trial Master File lacks critical documents. Version control missing. Document retrieval slow. Regulatory expectations unclear.
CRA monitoring visit reports lack linkage to deviations. Follow-up actions unclear. SOP compliance not tracked per site.
Source data missing complete audit trail. Case report form corrections not documented. EDC system validation incomplete. E-signature requirements unclear.
CRA observes during monitoring visit: Subject enrolled outside age window (protocol: 18—65 years; subject enrolled at age 16).
Site coordinator uploaded CRF weeks earlier with incorrect DOB. Deviation never reported to Sponsor.
CRA enters deviation in Verixa with GCP context selected. Protocol section referenced: Inclusion Criterion 1 (Age 18—65). Severity: Major (patient safety / data integrity impact).
Deviation linked to: Subject ID, visit date, protocol deviation type, site, CRA name.
Medical Safety Monitor assesses: "Subject age 16. Drug has not been studied in pediatric population. Baseline laboratory values within normal range. No adverse events reported."
Risk: Moderate (potential developmental impact, but no clinical evidence yet).
MIRA suggests: "Pediatric deviation. ICH E11 review recommended. Consider additional PK sampling to compare to adult cohort."
Verixa workflow auto-flags: "Major protocol deviation detected. Sponsor & IRB notification required within 48 hours per ICH E6(R2)."
Quality Lead notifies Sponsor Medical Safety within 24 hours. Sponsor initiates expedited review.
IRB notification prepared with risk assessment and mitigation plan.
Sponsor & Site agree: Site PI and all coordinators must retrain on inclusion/exclusion criteria. Knowledge assessment required. Training completion tracked in Verixa.
Corrective: Site retraining completed (3 days). PI signs off.
Preventive: Protocol screening checklist added to site CRF template to catch future enrollment errors before submission.
CRA monitoring visit 2 months later: Reviewed 5 new enrollments. All screened correctly against inclusion/exclusion criteria. Screening checklist completed for each. Zero enrollment errors.
CAPA marked effective.
Complete chain: Deviation → Risk Assessment → Sponsor Notification → CAPA → Effectiveness. Linked to TMF documents: Protocol, Investigator's Brochure, ICMJE ethics documentation.
BIMO Inspector Questions: "How did you handle the out-of-spec enrollment?" → Pulls up complete dossier with audit trail.
Major vs. minor deviations. Automatic severity classification. Sponsor notification triggers and timelines. IRB/EC review integration.
Document library organized per ICH E6(R2) sections. Version control. Completeness checklist. Regulatory-ready export for BIMO inspections.
Risk assessment leads to IRB notification decision. Template letters per deviation type. Tracking of IRB response and approval timeline.
Escalation alerts for SAE reporting deadlines. Expedited review triggers for major safety issues. SUSAR and DSMB reporting workflows.
CRA observations logged directly. Linked to protocol deviations and corrective actions from previous visits. Site performance dashboard.
$4,500—$6,000
Review of your trial conduct against ICH E6(R2), 21 CFR Parts 50/56/312, and CDSCO CT Rules. Includes protocol deviation management, TMF completeness, and data integrity assessment.
$15,000—$25,000
4-week intensive preparation for BIMO inspection. TMF remediation, deviation backlog review, site monitoring query resolution, and mock BIMO interview.
$12,000—$18,000
Expert CAPA for major protocol deviations or data integrity issues. Includes risk assessment, root cause analysis, and effectiveness verification design.
Harmonized guideline for good clinical practice. 14 sections covering study protocol, investigator qualifications, informed consent, safety reporting, and record-keeping.
FDA regulations for Protection of Human Subjects (Part 50) and Institutional Review Boards (Part 56).
FDA regulations for Investigational New Drug (IND) applications, including protocol amendments and safety reporting.
Clinical Trials Regulation (EU). Applies to all clinical trials in EU member states.
India's Good Clinical Practice guidelines under the Drugs and Cosmetics Act. Requirements for clinical trials in India.
World Health Organization recommendations for ethical conduct of human research.
See how Verixa manages protocol deviations and keeps your TMF audit-ready.
Pharmacovigilance compliance. ICSR processing. Signal detection.
Adverse event reports accumulate. ICSR data entry slow. Causality assessment delayed. SUSAR reporting deadlines missed.
Similar adverse events scattered across spreadsheets. Pattern recognition manual. Regulatory signal thresholds unclear.
Periodic Safety Update Report data quality inconsistent. Missing benefit-risk data. Outdated literature citations.
Pharmacovigilance System Master File incomplete. Procedures not current. Missing training records. Risk management plan not linked to ICSR processing.
Healthcare professional reports via MHRA Yellow Card: Female patient, age 52, on drug for 3 months, develops severe liver enzyme elevation (ALT 8× upper normal limit).
Pharmacovigilance specialist creates ICSR in Verixa with GVP context selected. MedDRA coding: "Alanine aminotransferase increased" (LLT 10001551).
Causality fields: Suspect drug, dose, frequency, duration. Concomitant medications. Medical history (alcoholism, hepatitis B exposure).
MIRA AI suggests: "Hepatotoxicity suspected. Naranjo score: 7 (probable). Similar reports in 2 other patients from same region (potential signal)."
Drug Safety Physician reviews MIRA suggestion via HITL gate: Confirms causality as "probable." Decides SUSAR (Suspected Unexpected Serious Adverse Reaction).
Verixa workflow auto-flags: "SUSAR detected. 15-day expedited report required per EU GVP Module IX."
Quality Lead prepares CIOMS-I form. Medical team consulted for narrative. Report submitted to regulatory authorities within 15 days.
MIRA continuously monitors: Identifies 3 hepatotoxicity reports over 2 months (normally 0.5 per month). Pattern emerges: All female, all over 50, all on concurrent acetaminophen.
Drug Safety Physician triggered by MIRA alert: Launches benefit-risk assessment.
Benefit-risk panel convenes: Balances drug efficacy against hepatotoxicity risk in female patients >50 years. Recommends liver function monitoring schedule.
PSMF updated: Risk management plan amended to include baseline LFTs and quarterly monitoring for this population.
Complete chain: ICSR → Causality → SUSAR → Expedited Report → Signal Detection → Benefit-Risk → Risk Management Plan Update. All audit-trailed.
Regulatory Inspection: "How do you detect signals?" → Pulls up MIRA signal detection dashboard showing pattern recognition across cohort.
Standardized form for adverse event capture. MedDRA coding integration. Causality assessment templates. Automatic SUSAR flagging based on EU GVP Module IX criteria.
Naranjo algorithm support. WHO-UMC assessment framework. Drug Safety Physician review workflows. HITL gate for SUSAR confirmation.
Expedited reporting timelines per ICH E2A. CIOMS-I form auto-population from ICSR data. Regulatory authority submission tracking.
Periodic Safety Update Report data collection. Automatic adverse event aggregation by system organ class. Trend analysis year-over-year.
ML model identifies unusual adverse event patterns. Disproportionality analysis. Clustering by patient demographics. Automated alerts for signal thresholds.
Pharmacovigilance System Master File auto-populated with procedures, contact information, and training records. Completeness checklist. Regulatory-ready export.
$4,500—$6,000
Review of your pharmacovigilance system against EU GVP Modules I—XVI, ICH E2 guidelines, and FDA expectations. ICSR processing, PSUR quality, and PSMF completeness assessment.
$15,000—$25,000
Intensive preparation for regulatory inspection (EMA, FDA, MHRA). ICSR backlog remediation, signal detection validation, and PSMF update.
$12,000—$18,000
Expert CAPA for ICSR processing delays, signal detection gaps, or PSUR quality issues. Includes system design review and risk management plan updates.
European Guideline on Pharmacovigilance for Medicinal Products. Covers PV system, ICSR evaluation, risk management, and periodic reporting.
Harmonized guidelines: E2A (CIOMS-I definition), E2B(R3) (electronic reporting), E2C (periodic updates), E2E (pharmacovigilance planning).
FDA regulations for IND safety reports and NDA adverse event reporting.
India's pharmacovigilance requirements under the Drugs and Cosmetics Act.
World Health Organization guidelines for global pharmacovigilance systems and adverse event reporting.
See how Verixa automates ICSR processing and detects emerging safety patterns.
GLP compliance. Study protocol adherence. Data integrity assurance.
Deviations from approved protocol not reported. Study Director unaware of procedural gaps. QAU inspection frequency inadequate.
Laboratory notebooks lack complete audit trail. Specimen storage data incomplete. Equipment performance records scattered. ALCOA+ requirements unclear.
Equipment qualification status unclear. Maintenance schedules drift. Facility environmental monitoring incomplete. Calibration records not linked to study data.
Specimen storage conditions not monitored continuously. Archive retention compliance unclear. Specimen accountability records incomplete.
QAU inspector observes: Temperature data logger for specimen storage freezer shows excursion (−18°C target, peak +2°C for 4 hours during weekend power outage).
QAU creates deviation in Verixa with GLP context. Study number, test facility, specimen type, storage area referenced. Deviation type: Equipment failure / Environment control excursion.
Study Director reviews: "Specimens in freezer: stability samples for 12-month toxicology study. Stability data shows drug is stable at −20°C ± 5°C. Excursion to +2°C for 4 hours = borderline exposure."
Risk: Moderate (specimen integrity potentially compromised; study may require re-dosing).
MIRA suggests: "Cross-reference stability data at +2°C for 4 hours. Compare to ICH Q1A(R2) guidance. Consider repeat analysis on affected specimens."
QAU / Facility Manager investigates: Freezer thermostat failed during power outage. Backup UPS system not installed (procedure gap). Maintenance logs incomplete.
Root cause: Equipment failure + inadequate preventive maintenance + missing backup system.
Corrective: Replace freezer thermostat. Install UPS backup system. Re-stabilize freezer at −20°C.
Preventive: Add monthly thermostat calibration check. Install high-temperature alarm with SMS notification.
Systemic: Update facility SOP to require UPS for all critical equipment. Schedule quarterly maintenance review.
Study Director reviews CAPA and affected specimens. Decision: Repeat stability analysis on 10 affected specimens. Results show drug potency within spec (99.2%—101.5%). Study data integrity confirmed.
QAU verifies: Archive integrity maintained. Specimen accountability 100%. No study data lost.
Complete chain: Deviation → Risk Assessment → RCA → CAPA → Study Impact Analysis → Archive Verification. All audit-trailed.
Regulatory Inspection: "Show me your deviation handling for study XYZ." → Complete folder with temperature logs, risk assessment, CAPA plan, repeat analysis, and QAU sign-off.
Study initiation, protocol oversight, deviation review, study completion report. Integration with protocol amendments and quality oversight activities.
Inspection schedules and frequencies per OECD GLP Principles. Inspection findings linked to deviation and CAPA management. Audit trail per OECD GLP.
Specimen receipt, storage location, usage tracking, archival status. Barcode integration for rapid accountability. Chain-of-custody documentation.
Protocol versions and amendments linked to study timeline. Study Director approval workflow. Impact on ongoing study sections documented.
Archive retention timelines per OECD GLP (usually 5 years minimum). Environmental monitoring for archive facilities. Specimen condition verification.
$4,500—$6,000
Expert review of your laboratory facility and study conduct against OECD GLP Principles, 21 CFR Part 58, and EU Directive 2004/10/EC. Includes QAU inspection adequacy and data integrity assessment.
$15,000—$25,000
Intensive 4-week preparation for GLP inspection. QAU records remediation, study file completeness, facility qualification verification, and mock inspection preparation.
$12,000—$18,000
Expert CAPA for equipment failures, protocol deviations, or data integrity issues. Includes Study Director consultation and archive integrity verification.
OECD Test Guideline 101 (Principles of Good Laboratory Practice). Covers test facility, personnel, equipment, protocol compliance, and records.
FDA Good Laboratory Practice for Nonclinical Laboratory Studies. Requirements for toxicology studies supporting INDs and NDAs.
European directive on Good Laboratory Practice. Applies to GLP-regulated studies conducted in EU member states.
India's Good Laboratory Practice guidelines under Drugs and Cosmetics Act. Applies to preclinical testing in India.
World Health Organization recommendations for Good Laboratory Practice in non-clinical safety assessment.
Good Clinical Laboratory Practice. Applies to laboratory testing supporting clinical trials and patient care.
See how Verixa ensures study integrity and archive compliance.
GDP compliance. Cold chain management. Counterfeit prevention.
Temperature logger data not monitored in real-time. Excursions discovered late. Product impact assessment manual and subjective.
Transportation routes not validated. Carrier qualifications incomplete. Performance data not trended.
Serialization tracking incomplete. Distribution channel visibility limited. Product pedigree not auditable.
Warehouse environmental monitoring incomplete. Cleanliness standards not enforced. Storage container integrity not verified.
Temperature logger on shipment of biologic (storage: 2—8°C) flags excursion: Peak temperature 12°C for 6 hours during transit delay in customs.
Verixa receives real-time alert via IoT integration.
Quality team creates deviation in Verixa with GDP context. Shipment ID, product, route, carrier, duration, peak temperature recorded. Deviation type: Temperature excursion.
Quality Lead reviews: Stability data for biologic shows acceptable limits up to 25°C for 2 hours. Excursion: 12°C for 6 hours = borderline impact on protein stability.
MIRA queries: "10 similar temperature excursions in past 12 months for this product on this route. Failure rate: 0%. Products remained within spec."
Risk: Low to Moderate. Recommendation: Release with accelerated stability monitoring (monthly vs. quarterly).
Root cause: Customs delay + inadequate insulation in carrier's cold storage unit.
Corrective: Requalify route with new customs broker. Upgrade carrier's insulation systems.
Preventive: Add temperature alert threshold at 10°C (vs. 12°C) to trigger rerouting. Require real-time GPS + temperature monitoring for all shipments.
Quality Pharmacist (QP) reviews risk assessment and CAPA. Decision options:
HITL Gate: QP signs off: "Release with accelerated 1-month stability monitoring."
30 days later: Next 5 shipments on same route. Temperature logger data: All within 2—8°C range. New customs broker on schedule. Carrier's upgraded insulation verified.
CAPA marked effective.
Complete chain: Excursion → Risk Assessment → QP Disposition Decision → CAPA → Effectiveness. Temperature logs, stability data, QP signature, carrier audit results all linked.
Regulatory Inspection: "How do you handle temperature excursions?" → Complete dossier: excursion logs, stability impact analysis, QP sign-off, CAPA implementation.
Real-time monitoring via IoT integration. Automated alerts. Historical excursion data. Stability impact assessment based on product data.
Shipment tracking from warehouse to destination. GPS + temperature + humidity monitoring. Real-time status updates. Proof of delivery capture.
Route qualification documentation. Carrier performance dashboard. Environmental monitoring at warehouse and in-transit. Alert thresholds per product.
Storage area environmental monitoring. Cleanliness audit checklists. Container integrity verification. Pest control records. Training certification tracking.
Qualification status per route. Carrier audit schedule. Performance metrics (on-time delivery, temperature compliance). Requalification triggers.
QP review and sign-off. Disposition options (release, release-with-conditions, quarantine, rework, return). Documentation for regulatory file.
$4,500—$6,000
Review of your distribution network against EU GDP Guidelines 2013/C 343/01, WHO GDP, DSCSA (USA), and PIC/S guidelines. Warehouse, transport, and temperature monitoring assessment.
$15,000—$25,000
Intensive 4-week preparation for regulatory inspection. Warehouse qualification completion, temperature excursion remediation, carrier audit completion, and mock inspection.
$12,000—$18,000
Expert CAPA for temperature excursions, carrier failures, or warehouse deficiencies. Includes QP consultation for batch disposition decisions.
European guidelines for Good Distribution Practice. Covers wholesale distribution, transport, storage, and recall management.
World Health Organization guidelines for Good Distribution Practice for pharmaceutical products.
US Drug Supply Chain Security Act. Requires serialization, track-and-trace, and licensing of distributors.
Pharmaceutical Inspection Convention/Co-operation Scheme Good Distribution Practice guidelines.
India's Good Manufacturing Practice for Pharmaceutical Products. Includes distribution and storage requirements.
Stability testing guidelines. Defines temperature and humidity conditions for storage and handling.
See how Verixa manages cold chain compliance and batch disposition workflows.
You buy Verixa. We ensure your success.
From deployment to GAMP 5 IQ/OQ/PQ validation to managed oversight.
Self-hosted or customer cloud setup. GxP domain configuration. User provisioning and access control. Data migration from legacy systems. 4-week typical timeline.
Installation Qualification (IQ): Infrastructure, dependencies, system installation. Operational Qualification (OQ): Functional testing, workflows, audit trail verification, e-signature validation. Performance Qualification (PQ): Load testing, regulatory-ready validation package. Full traceability to 21 CFR Part 11 requirements.
End-user training (system navigation, GxP workflows, HITL governance, audit trail review). Trainer-of-trainers program. Change management communication plan. Role-based knowledge base development.
Ongoing platform management and oversight. Monthly compliance reviews and analytics. Regulatory update mapping and implementation. 24/7 escalation support with SLA guarantee.
$4,500—$6,000
10-Day Assessment
Deliverables:
Timeline: 2 weeks from kickoff to report delivery.
$15,000—$25,000
4-Week Intensive Engagement
Deliverables:
Timeline: 4-week sprint before scheduled inspection.
Risk: No guarantee of inspection outcome. Our goal is maximum readiness.
$12,000—$18,000
6-Week Project
Deliverables:
Timeline: 6 weeks from findings to CAPA closure.
Cost: Up to $18k for cross-functional, high-complexity CAPAs.
Initial call to understand current state, regulatory context, and scope. Detailed statement of work (SOW) with timeline and success criteria.
Documentation review, on-site facility/process observation, staff interviews, data sampling. Parallel gap analysis against regulatory frameworks.
Risk-ranked findings with root cause analysis. Remediation roadmap with resource estimates and timelines. Detailed written report.
Optional: Navira QA facilitates remediation (SOP rewrite, document remediation, CAPA execution, training). Milestone-based checkpoints.
Final compliance verification. Regulatory-ready documentation package. Team training and knowledge transfer. Post-engagement support (30 days, included).
30+ Verified QA Professionals. 200+ Combined Years of GxP Experience.
PharmD, PhD, or BS in Chemistry/Chemical Engineering + 10+ years GMP. FDA 483 experience. Equipment qualification, batch record deviations, CAPA expertise.
RN or equivalent + 8+ years clinical trial experience. BIMO inspection knowledge. Protocol deviation, TMF management, IRB coordination background.
PharmD + 10+ years PV. ICSR processing, signal detection, PSUR expertise. Familiar with EMA, FDA, CDSCO PV requirements.
PhD Chemistry or Biology + 8+ years GLP. Study Director experience. OECD GLP, facility qualification, data integrity focus.
Bachelor's in Pharmacy or Supply Chain + 8+ years logistics/distribution. Cold chain, warehouse, transport qualification expertise.
Verixa is the platform (software). Navira QA is the services team (human expertise). You license Verixa for your organization. You hire Navira QA for implementation, consulting, and specialized expertise.
Both. For projects like Compliance Audits, we work independently and report findings to your leadership. For Inspection Readiness Sprints and CAPA execution, we work embedded with your team, facilitating remediation. Your team leads; we guide.
Yes. If an inspection generates 483 observations or Warning Letter, we can scope a targeted CAPA engagement to address findings. Cost depends on complexity and scope. Typical timeline: 8—12 weeks.
All Navira QA professionals sign NDAs. We follow HIPAA, GDPR, and client-specific confidentiality agreements. No client data is shared across engagements. Audit reports are proprietary to your organization.
We document our recommendation with regulatory citations and rationale. If you prefer a different approach, we'll document that decision and the supporting rationale. Ultimately, your organization owns the compliance decisions. We advise.
Contact us via the form below. We respond within 24 hours. Initial discovery call is free. Scope and pricing confirmed within 5 business days. Project start typically within 2—4 weeks (subject to expert availability).
Founder & CEO
20+ years in clinical quality assurance across GCP, GLP, GMP, pharmacovigilance, and computerized systems validation. PhD in Biochemical Pharmacology. Regulatory Affairs Certified (RAC). Before founding Verixa, Vimal led quality assurance programs at Genentech (7 years), Myokardia/BMS, Arcellx, and Alumis—spanning Phase I through Phase III clinical trials, biologics manufacturing, and cell therapy quality systems.
Published researcher with work in the Journal of Biological Chemistry and Circulation. Former research fellow at Helmholtz Munich, Tufts Medical Center, and Northwestern University Feinberg School of Medicine.
Why Verixa? After an FDA inspection where a CAPA took 8 weeks to close (and was still incomplete), Vimal realized the industry needed a platform that combines HITL governance, AI-assisted workflows, and immutable audit trails. Most QMS platforms focus on data capture, not on actual compliance decision-making. Verixa fixes that.
Co-Founder, CTO
Previously Head of Engineering at Diana Health and CTO at Zita. MS from NIT Trichy. Led platform architecture, AI/ML integration, and 21 CFR Part 11 compliance design.
Product Lead
Former product manager at Veeva and Salesforce. Led GxP workflow design and HITL governance feature roadmap.
Engineering Head
15+ years full-stack engineering. Led backend systems design, API architecture, and audit trail implementation.
Compliance Head
PharmD, former QA Director at contract lab. Leads GxP module design and regulatory strategy. Ensures every feature passes compliance rigor.
Software Engineering QA
10+ years QA. Leads testing, validation, and Part 11 compliance verification for platform releases.
Operations
Manages customer onboarding, support, and success. Coordinates with Navira QA services team.
29 years in enterprise technology. Former SBU Head at Exavalu. Brings deep experience in GxP compliance technology and regulatory market dynamics.
Navira delivers the service. Verixa strengthens the work. Humans own the judgment.
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Questions about Verixa or Navira QA services? We're here to help.
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Last updated: March 2026
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Either party may terminate the Service Agreement with written notice. Upon termination, all rights granted are revoked and you must cease using the platform.
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Last updated: March 2026