How does an electronic document management system support 21 CFR Part 11 compliance?

An electronic document management system built for 21 CFR Part 11 binds e-signatures to specific users and actions, timestamps every change in an immutable audit trail, and restricts access by role, so signature integrity and record traceability are enforced by the system itself rather than a manual SOP someone has to remember to follow.

Can a pharmaceutical document management system integrate with ERP and LMS?

Yes. KOŚA's document management system for pharmaceutical industry teams integrates with ERP and LMS so that a document, a batch record, a spec, and a COA stay consistent as a single record across systems, instead of separate, possibly conflicting copies living in each platform.

What documents does GxP document control typically cover?

GxP document control spans SOPs, batch and manufacturing records, validation and qualification documents (URS, IQ/OQ/PQ), clinical trial protocols, regulatory submissions, QC records, change control, CAPA, and periodic quality reviews, essentially any document a regulator could ask to trace from draft to current effective version.

How long does it take to implement a document management system for pharmaceuticals?

Most pharmaceutical DMS implementations, including KOŚA's, go live in 6–8 weeks through a phased rollout: discovery and migration planning; workflow configuration and validation/UAT alongside your CSV package; and a phased go-live with role-based training, designed so document control continues running during the transition rather than pausing for cutover.

Document Management System

The Document Management System for the Pharmaceutical Industry.

Document control that holds up when the inspector walks in.

KOŚA DMS is the document management system for pharmaceutical industry teams that routes every SOP, batch record, and validation document through one configurable workflow -version-controlled, e-signed, and audit-trailed for 21 CFR Part 11, EU GMP Annex 11, and ISO 13485.

Trusted by quality & document control teams in pharma, biotech & medical devices

HOW DIFFERENT ROLES BENEFIT

One DMS. Every team aligned.

Controlled document lifecycle, end-to-end.

✓ Manage creation, review, approval, release & retirement in one structured workflow
✓ Track every change with audit trails aligned to 21 CFR Part 11
✓ Schedule periodic reviews and chase overdue documents automatically

HOW QUALITY ASSURANCE USES DMS IN PRACTICE

✓Maintain controlled SOPs across quality processes
✓Route SOPs through controlled workflows with e-signatures
✓Ensure only effective versions are accessible to end users
✓Link documents to training rules and assign automatically

Regulatory submissions, fully traceable.

✓Keep regulatory submissions under the same version control as internal SOPs
✓Tie change control records to dossier updates for full traceability
✓Retrieve any historical submission package in seconds, not days

HOW REGULATORY AFFAIRS USES DMS IN PRACTICE

✓Manage NDA/MAA-style submission documentation centrally
✓Link periodic product quality reviews (PQR) to source records
✓Track correspondence history against agency queries

Research documentation, kept airtight.

✓Link documents to change control and CAPA for full traceability
✓Standardise study and method documents with reusable templates
✓Compare any two versions side-by-side to see exactly what changed

HOW R&D USES DMS IN PRACTICE

✓Maintain protocol and method documentation through every revision
✓ Keep validation & qualification documents (URS, IQ/OQ/PQ) version-controlled
✓Collaborate on drafts without losing control of the master copy

Shop-floor documents, always current.

✓Give shop-floor teams access to only the current, effective procedure
✓ Flag superseded and obsolete copies before they ever reach the line
✓Trigger document reviews automatically from deviations and CAPAs

HOW MANUFACTURING & OPS USES DMS IN PRACTICE

✓Manage batch and manufacturing records alongside governing SOPs
✓Trigger document reviews automatically tied to deviations and CAPAs
✓Standardize across sites with shared templates and workflows

Full visibility, at a glance.

✓Retrieve approved documents in seconds from one repository
✓Monitor backlogs and compliance KPIs across every site
✓ Walk inspectors through an immutable, time-stamped audit trail

HOW MANAGEMENT USES DMS IN PRACTICE

✓Monitor document backlogs and overdue reviews on one dashboard
✓Track compliance KPIs across sites and business units
✓Use audit-readiness reporting to brief the board or investors

Reporting & Analytics

Real-time visibility into every document.

Live dashboards expose completion rates and compliance metrics – exports produce audit-ready documentation for every review.

“Our document control team works much more effectively since we implemented KOŚA pharmaceutical document management software. The workflows are intuitive and our audits have never been smoother.”

Quality Affairs Lead · Mid-market Pharma Manufacturer