Run an AI powered compliant cloud based SaaS eQMS without the chaos
AI-empowered cloud SaaS with in-region data residency — deploy in USA • EU • Asia Pacific • Middle East • Australia/NZ with committed uptime and audit-ready controls
Why regulated teams choose Complere?
21 CFR Part 11-ready
Time-stamped audit trails, RBAC and electronic signatures
Role-based access enforces least privilege; e-signatures record identity, meaning, and intent for each controlled action.
Pre-Validation Documentation Suite included
You get traceability, risk checks, IQ/OQ scripts, and a Part 11 review.
We adapt the templates; your QA reviews and signs off.
complere adapts to regulated workflows across Pharma, Med-Devices, F&B, and more
Pharma, medical devices, food, biotech, and manufacturing teams rely on our eQMS aligned with ISO, GMP, HACCP, and 21 CFR Part 11. Version and audit diffs, no hard deletion and restore, and configurable labels ensure compliance. Cross-linked records, AI insights, and regional hosting keep you efficient and audit-ready.
Modules offered
Controlled Document Management
Versioning, approvals, side by side version comparison, inline viewer, periodic review—plus AI-suggested summary for quick review.
Training & LMS
Assign curricula, micro-quizzes, material wise retraining, retraining rules, & evidence tracking; AI helps draft quizzes from supplied Document and Tasks.
Quality Events (Customer Complaints/NCs/Deviations)
Built-in investigations from intake to QA review; timestamps, built in 5 whys, attachments, and AI-drafted investigation summaries & 5 whys.
CAPAs
Close issues faster with smart routing, reminders, closure dependencies configuration, escalations, and effectiveness checks—AI summaries speed reviews.
Controlled Changes
Impact/risk assessment, approvals, implementation, and verification, closure dependencies configuration—linked to CAPA and docs with full traceability.
dashboard & KPI
Overdue quality items, quality items calendar to see ongoing work list, complaint TAT, training compliance, and trends—AI highlights likely hotspots.
Pilot Complere in 30–45 Days
AI-assisted eQMS in a safe, audit-ready workspace. Validate CAPA, Events (built-in investigations), and Document Control—keep your setup and artifacts.
AI-enabled modules
AI-assisted eQMS in a safe, audit-ready workspace. We make sure you dont have to leave page to review text with our assisted AI everywhere across the modules. AI turns verbose notes into clear summaries and eases Users’ lives .
Prove it
fast
Week 0–1: Configure
Weeks 2–4: Operate
Week 5: Audit
Weekly check-ins and KPIs so results are measurable.Track baselines versus improvements with dashboards, reports, & automated reminders.
Validation & perks
Pre-Validation Documentation Suite included; export anytime. Founder pricing and roadmap priority if you continue. Ready validation suite accelerate audits while QA retains ownership of final validation.
Quality & Compliance Insights
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CAPA vs Correction: What’s the Difference (with Examples)
Introduction If you work in Quality, you’ve felt the tug-of-war between fixing something fast and fixing it for good. A mislabeled bottle is easy to reprint (correction), but the pattern of mislabels is a different beast that requires root-cause work (CAPA). Mixing these up clogs your system with either too many CAPAs or too many…
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Electronic Signature vs Digital Signature (Part 11 Made Simple)
Introduction Teams often confuse electronic signatures (e‑sign) with digital signatures. In Part 11 contexts, you need to prove identity, intent, and linkage to the record. Cryptography can help—but it’s not always mandatory. Here’s the clear view. E‑sign in regulated environments An e‑sign is data in electronic form that a person adopts as their signature. In…
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Audit Trail vs Audit Log: What Regulators Actually Expect
Introduction “Audit trail” and “audit log” are used interchangeably, but they’re not the same in regulated contexts. System logs are useful for admins; audit trails must stand up in quality and regulatory inspections. Here’s how to tell them apart and make yours review‑ready. What is an audit trail? A secure, immutable, time‑stamped record of who…
