Document control for life sciences teams.
Built by life science experts to simplify document control.
“Our document control team works much more effectively since we implemented KOŚA. The workflows are intuitive and our audits have never been smoother.”
Improved traceability & automation
Centralise document control and replace manual routing with automated, configurable workflows. Reduce manual coordination across teams.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — keeping documentation inspection-ready at all times.
Data-driven oversight
Monitor document activity, review backlogs and compliance KPIs in real time. Give QA leadership the visibility they need.
Faster implementation
Go live in 6–8 weeks with structured implementation, training and 24/7 support — without disrupting existing operations.
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
Stay audit-ready with
regulatory-grade controls.
- Map documents directly to 21 CFR, ISO 13485, and EU MDR requirements
- Maintain tamper-evident, time-stamped records for every document action
- Generate submission-ready document packages in one click
Accelerate R&D without
losing document control.
- Version-control research protocols and lab notebooks automatically
- Link experimental data directly to related SOPs and design documents
- Accelerate design freeze with traceable review and sign-off workflows
Ensure shop-floor teams always
use the right revision.
- Distribute approved procedures instantly to manufacturing lines
- Obsolete old revisions automatically when new versions go effective
- Capture read-and-understood acknowledgements for every operator
Full visibility across your
entire document ecosystem.
- Real-time dashboard showing document status across all departments
- Identify bottlenecks with approval cycle-time analytics
- Ensure cross-functional alignment before audit season
From draft to obsolete — every step controlled.
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
- Maintain audit trails of every change and approval
Control documents across quality & manufacturing
- Link documents to change control and CAPA for full traceability
- Standardise with templates to reduce errors
- Track version and approval history in one place
- Provide centralised access across teams
Prepare for audits with confidence
- Retrieve approved documents in seconds from one repository
- Show training records linked to current procedures
- Walk inspectors through immutable audit trails
- Manage the full lifecycle from draft to obsolete
Maintain controlled documentation across projects
- Control document access by role, project or team
- Standardise across projects with templates and workflows
- Track document relationships and dependencies
- Support collaboration and audit-readiness in parallel
Everything you need to run a controlled document system.
Eight capability pillars that come standard — no add-ons, no surprises.
Automated workflows
Guide documents through draft, review, approval and effective stages with less manual follow-up.
Electronic signatures
Capture traceable approvals with e-signatures designed to align with 21 CFR Part 11.
AI-powered summaries
Generate change summaries automatically to support faster, more consistent review.
Version control & history
Work from the latest approved document with clear version history and full traceability.
Role-based access control
Control who can view, edit, review or approve documents — by role, site or project.
Properties & classification
Classify by type, process, owner and effective date for better control and discoverability.
Microsoft Office integration
Draft and edit in Microsoft Word while keeping document control inside KOŚA.
Search, filtering & navigation
Find controlled documents faster using full-text search, filters and document properties.
Built to align with the regulations you live by.
KOŚA DMS helps you implement document control processes that maintain traceability, controlled access and documented oversight — across the entire document lifecycle.
Talk to a compliance architectSee KOŚA DMS in your environment.
Book a 30-minute walkthrough with a compliance architect — tailored to your SOPs, your workflows and your audit calendar.