ValiCore is 31 compliance modules sharing one data model, one audit trail, and one e-signature stack. Every module is wired into the next — an OOS investigation reads from QC, a recall reads from batch records, an APQR pulls from every module across the review period.
What a QC analyst touches every day. Calibration, tests, certificates, reagents, equipment uptime.
Every instrument, every certificate, every overdue alert — in one place.
Master instrument register with calibration frequency, last/next due dates, NABL-traceable certificates, and automatic overdue blocking. Out-of-tolerance results trigger OOC impact assessment.
21 CFR 211.68 · USP <1058> · ISO 17025
30/60/90-day forecasts so nothing goes overdue.
Monthly calendar view of every calibration due in the next 90 days. Vendor coordination, internal scheduling, and audit-ready calibration forecast PDFs.
21 CFR 211.68(a)
Every test, every result, every standard — with a single source of truth.
Per-test records linked to analyst, instrument, standard lot, and acceptance criteria. Pass/Fail/OOS automatic spec check. CSV/Excel bulk import for legacy test data.
21 CFR 211 Subpart I · EU GMP Ch.6
Customer-facing CoAs with locked specs and 21 CFR Part 11 e-signatures.
Auto-numbered CoAs tied to release-test results. Locked specs from registration dossier. Print-ready PDFs with company letterhead and approver e-signature.
21 CFR 211.165 · ICH Q6A
Lot-level traceability with shelf-life and opened-date countdowns.
Every lot tracked from receipt to disposal: catalogue number, manufacturer, expiry, opened expiry (often shorter), storage conditions, qualification status. Expired-lot block on new test entry.
21 CFR 211.84 · USP <11>
Preventive + corrective tasks scheduled by instrument.
PM/CM task scheduling with priority, assignee, due date, and outcome. Linked to instruments so a single failed calibration triggers a corrective task automatically.
21 CFR 211.67 · ISO 13485 §7.5.1
Digital replacement for handwritten instrument and room logs.
Instrument usage, room cleaning, fridge/incubator temperature, equipment startup/shutdown. Every entry attributed, time-stamped, and tamper-evident.
21 CFR Part 11 · EU GMP Annex 11 · MHRA Data Integrity
When something goes wrong. Incidents, OOS, complaints, recalls — with workflow and e-signatures.
Structured deviation handling with CAPA workflow built in.
Severity classification (Minor/Major/Critical), root-cause analysis (5-Why, fishbone), CAPA actions with effectiveness check, and full audit trail. Linked to the originating batch.
21 CFR 211.192 · ICH Q10 §3.2.3
FDA Phase 1A → 1B → Phase 2 with locked deadlines.
Phase 1A laboratory investigation within 4 hours, Phase 1B retest within 24 hours (QA Manager-approved), Phase 2 full investigation within 30 days. Final disposition with e-signature.
FDA OOS Guidance (Oct 2022) · USP <1010>
When a calibration fails, find every test that was impacted.
Reverse-traces every test, batch, or release made between the last good calibration and the failed one. Drives retest / quarantine / recall decisions backed by data.
21 CFR 211.68(b) · MHRA OOC Position Paper
30-day reply clock and adverse-event escalation built in.
Complaint intake with category, severity, adverse-event flag, and 30-day reply countdown. Auto-link to recall or CAPA. Trending in APQR.
21 CFR 211.198 · Schedule M §17 · ICH Q10
Class I/II/III recalls and the Schedule M §28 annual mock recall.
Coordinator-led recall execution: distribution scope, regulator notification, consignee tracking, effectiveness check (≥90%), and termination/closure. Mock-recall flag for the annual drill.
21 CFR 7 · Schedule M §28 · WHO TRS 1019
Every change risk-assessed before it ships.
Change classification (Minor/Major/Critical), impact assessment, implementation plan, and post-implementation review. Regulatory-filing flag for changes requiring variation submission.
21 CFR 211.100 · ICH Q10 §3.2.3 · EU GMP Ch.1 §1.4(xiv)
Live risk register fed by every quality event in the system.
Likelihood × severity matrix per process. Risks auto-populate from incidents, OOS, OOC, complaints, and audit findings. Risk owner and mitigation status tracked.
ICH Q9 · ISO 14971
Long-running studies and protocols. AI Validation Engine writes IQ/OQ/PQ for you.
Auto-generated IQ/OQ/PQ protocols you can run today.
Describe the equipment or system; the AI generates a draft validation plan with IQ, OQ, PQ tests aligned to the equipment category. Edit, approve, execute, and e-sign within the same record.
GAMP 5 · 21 CFR Part 11 · ICH Q9
ICH Q2(R2) parameter-by-parameter validation with locked acceptance criteria.
Protocol → execution → report workflow for assay, impurity, dissolution, content uniformity, identification, limit-test, and identification methods. Per-parameter results with pass/fail vs acceptance.
ICH Q2(R2) · USP <1225>
MACO calculations and worst-case worst-location swab analysis.
Equipment train + previous/next product → MACO via APIC formula + 10ppm + PDE comparison. Limit-per-swab and limit-per-rinse-mL auto-calculated. Three-consecutive-run protocol with locked acceptance.
EMA EMA/CHMP/CVMP/SWP/169430/2012 · PIC/S PI 006 · FDA 1993 Cleaning Guide
Pull schedule with ±window monitoring per ICH Q1A(R2).
Study setup with conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH), time points, and test panel. Pull schedule with overdue alerts. Per-pull test results with spec check.
ICH Q1A(R2) · ICH Q1E · USP <1196>
EU GMP Annex 1-aligned EM with alert/action limit tracking.
Per-area sampling plan (active air, settle plate, surface contact, glove print). Limits per ISO class. Trend review with alert-limit early warning before action-limit excursion.
EU GMP Annex 1 (2022) · USP <1116> · ISO 14644-1
Inter-laboratory comparison with z-score evaluation.
Schedule, distribute, and assess inter-lab proficiency studies. Capture submitted results, scheme provider feedback, z-score, and corrective action for outlier results.
ISO/IEC 17043 · NABL 163
Every URS requirement traced to a test, owner, and coverage.
Functional, non-functional, performance, security, integration, and regulatory requirements. Coverage status (Covered / Partial / Not Covered). Linked to the test that demonstrates compliance.
GAMP 5 §M5 · ISO/IEC 25040
Annual Product Quality Review auto-aggregated from QC, OOS, incidents, batches, complaints, and changes.
Pulls every release test, OOS investigation, deviation, change control, complaint, and batch record across the review period for the chosen product. Cpk and yield trends. Reviewer + approver e-signatures.
21 CFR 211.180(e) · Schedule M · EU GMP Ch.1
Batch records and supplier qualification — the production-floor surface.
Electronic batch records with in-process checks and yield reconciliation.
Master template → batch instance → in-process check capture → reconciliation. Deviations linked at the batch level. Locked once released.
21 CFR 211.188 · Schedule M Part I
Approved Vendor List with audit schedule and certificate expiry tracking.
Qualified / Conditional / Disqualified / Pending status per supplier with risk classification (Low/Med/High/Critical). Next audit forecast, certificate expiry countdown, and qualification renewal workflow.
21 CFR 211.84 · ICH Q10 §3.2.4
Training records, document control, internal audits, and the tamper-evident audit trail.
Training matrix per role, assignment per person, competence sign-off per skill.
Role-based training matrix, induction tracking (30-day target), role-specific training (60-day target), and refresher cycle. Competence sign-off by department head before independent work.
21 CFR 211.25 · EU GMP Ch.2 · Schedule M
Controlled documents with lifecycle, e-signatures, and 10-year retention.
Draft → review → approve → effective → periodic review → retired/superseded. Reviewer + approver e-signatures bound to document hash. Effective and review-due dates with auto-reminder.
21 CFR 211.180(e) · 21 CFR Part 11 §11.50 · EU GMP Ch.4
Mock CDSCO/WHO-GMP inspections and quarterly internal audits with finding tracking.
Audit planning (scheduled, mock, for-cause), team and auditee tracking, finding logger (Critical/Major/Minor/Observation), and CAPA-linked closure. Mock-inspection mode for pre-inspection readiness.
21 CFR 211.180(e) · EU GMP Ch.9 · WHO TRS 1019
Every change, every signature, every login — hash-chained and immutable.
Append-only audit log with cryptographic chain (each row's hash includes the previous row's hash) so any tampering is detectable. Filterable by user, action, entity, and date range. PDF export for inspectors.
21 CFR Part 11 §11.10(e) · EU GMP Annex 11 §9
AI Assistant, analytics, and live dashboard. Ask your data instead of querying it.
Ask 'What's my compliance score?' and get an answer from live data.
Natural-language Q&A over your live compliance data: overdue calibrations, open incidents, CAPA effectiveness, training gaps, and audit-readiness gaps. Source citations included.
12-week trends and distributions across QC, calibration, incidents, and CAPA.
Compliance KPI cards (pass rate, overdue, open incidents, open CAPA). 12-week QC trend, calibration status distribution, incident severity, CAPA status — all derived from live data.
Generate a complete pre-inspection report in 10 seconds.
Compliance score, instrument summary, incident list, OOS list, CAPA list, audit log excerpt, and AI-generated risk summary — packaged into a regulator-friendly PDF for your next inspector visit.
We'll spin up a demo org pre-loaded with sample QC, instruments, incidents, and SOPs that look like your lab. 30 minutes. No pressure.
Book a free 30-min demo