Cognidox is a lean, enterprise‑grade Document Management System (DMS) and eQMS used by medical device/IVD manufacturers, biotech & pharma ops (GxP), CRO/CMO organisations, and high‑tech product teams. It combines controlled documents, workflows, e‑signatures, design tools, quality modules and training so you can scale compliance without slowing delivery.

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Cognidox helps teams implement controls aligned to ISO 13485 and ISO 9001, supports FDA 21 CFR Part 11/820 for e-records/e-signatures and quality system requirements, and follows ISO 27001 practices for information security. It’s also suitable for GxP use in both the US and EU—including FDA GxP expectations and EU GMP (Annex 11) principles for computerized systems. Learn more: /lean-eqms · /e-signatures

Both. Cognidox provides a robust DMS (version control, reviews, approvals, release, audit trails, e-signatures) and an eQMS layer with preconfigured quality modules (e.g., CAPA/NCR, Change, Supplier, Complaints, Deviations/Concessions, ECR/ECO) plus an integrated LMS that you can use immediately. As your processes evolve, you can adjust fields, routing, and approvals or create additional modules, while maintaining full governance and traceability.
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Cognidox is process-aware: documents move through governed workflows with required reviewers/signers, clear draft→release states, and effective dates.

It adds Part 11 e-signatures, immutable audit trails, and mandatory metadata—so you always know the latest approved record.

You get traceability (e.g., SOPs → training; DHF/DMR/DHR on demand) and read-only extranet sharing without uncontrolled copies.

Result: a single source of truth built for compliance, not just file storage.

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Yes—Cognidox manages all common and specialist file types with the same controlled lifecycle (versioning, review/approval, e-signatures, optional watermarking). For CAD/ECAD, you can upload the master file and a PDF view, so anyone can review and comment even without the CAD tool. Released copies can be shared via read-only links, keeping a single, traceable source of truth.

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Two options, both controlled. Use Limited Access Partner accounts to let selected suppliers/partners/auditors work inside Cognidox with strictly limited permissions (view/upload/download only in defined areas). Or publish read-only content to the managed Extranet portal, with licensing, expiry and watermarking—ideal for sharing releases or even public pages (e.g., data sheets, policies) so end users always see the latest approved copy. Access and downloads are fully logged.

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Released documents can create LMS assignments automatically. Evidence shows who read/understood which version and when, satisfying auditor expectations.

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You become lean by implementing only the controls you need—nothing more. Cognidox gives you a robust DMS and preconfigured quality modules/LMS you can switch on selectively. Workflows, fields, and signers match your SOPs (no forced extra steps or “one-size-fits-all” stages). As you grow, add or refine modules without bloat—staying compliant without over-processing.

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Most teams achieve a usable baseline within weeks: controlled document library, key SOPs, training assignments, and key quality workflows. Expand module‑by‑module as processes formalise.

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Immutable audit trails, e‑signatures, and on‑demand evidence packs make it simple to demonstrate intent, execution, and outcomes across CAPA, change, training, and suppliers.

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