Batch & Manufacturing Records
Raw materials through release testing
Document Management System
The Document Management System for the Pharmaceutical Industry.
Document control that holds up when the inspector walks in. KOŚA DMS 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
PharmaCorpBioGenexMediLabsCuraVitaNovaPharmBioTrust
What you can achieve
Built by life science experts to simplify document control.
One controlled system replaces the shared drives, email threads and binders that quality teams stitch together by hand.
Automated & traceable
Centralise document control and replace manual routing with 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.
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
Why a centralized DMS matters
The case for one controlled system, not six workarounds.
An electronic document management system for the pharmaceutical industry is critical to compliance, quality and safety. Companies that meticulously control their documents mitigate risk and maintain the highest quality standards across drug development and production.
COMPLIANCE
Regulatory compliance, by default
Good Documentation Practice (GMP) and GCP expectations are enforced inside the workflow itself - not reconciled afterwards at audit time.
INTEGRITY
Data integrity you can stand behind
Every field, edit and signature is captured under ALCOA++ principles, so the record holds up on its own in front of an inspector.
Audit Trail
One immutable trail, start to finish
A single audit trail follows each pharma document from first draft through every review, approval, re-issue and retirement.
RISK
Risk surfaced early, not at inspection
Configuration drift, overdue reviews and unassessed changes are flagged while they're still cheap to fix.
Teamwork
One controlled copy, every team
QA, regulatory, manufacturing and lab staff work from the same effective version in real time, wherever they sit.
ACCESS
A centralised repository
Replaces the shared drives, email threads and binders that document control teams currently stitch together by hand.
What a pharma DMS controls
Built for the documents regulators actually ask for.
From raw-material receipt to product release, every step of the pharmaceutical document management system produces a controlled document. KOŚA is built around the records that matter most during an inspection.
Standard Operating Procedures
Lab, cleaning and equipment SOPs
Clinical Trial Protocols & Reports
GCP design, methodology and results
Regulatory Submissions
NDA / MAA dossiers & correspondence
Quality Control Records
Raw material, intermediate and final QC
Validation & Qualification Docs
URS, IQ / OQ / PQ
Change Control & CAPA
Impact assessment and sign-off
Periodic Quality Reviews
PQR and stability data
Reporting & Analytics
Real-time visibility into every document.
Live dashboards expose completion rates and compliance metrics – exports produce audit-ready documentation for every review.
- Live dashboards for backlog, compliance and overdue reviews
- Audit-ready evidence packs exported on demand
- Custom reports for management review
- Compliance KPIs tracked across every site
Capabilities
Everything you need to run a controlled document system.
Capability pillars that come standard - no add-ons, no surprises.
Automated workflows
Draft, review, approval and effective-stage routing.
Electronic signatures
Traceable approvals aligned to 21 CFR Part 11.
AI-powered summaries
Automatic change summaries for faster review.
Version control & history
The latest approved document with full traceability.
Role-based access control
Control access by role, site or project.
Properties & classification
Classify by type, process, owner and effective date.
Microsoft Office integration
Draft in Word while control stays inside KOŚA.
Search, filtering & navigation
Full-text search and document properties.
Training records management
Link documents to training assignments.
ERP & LIMS integration
One consistent record across systems.
Reporting & analytics
Track metrics, backlogs and compliance status.
Secure collaboration
Work simultaneously without losing version control.
Regulatory frameworks
Built as the electronic DMS for pharmaceutical industry teams - not a paper-trail patch.
KOŚA helps you implement document control processes that maintain traceability, controlled access and documented oversight across the entire document lifecycle.
21 CFR Part 11
Electronic Records & Signatures
Audit trails, access control and signature binding.
21 CFR Part 211
cGMP Documentation
Including §211.22 quality-unit procedures.
21 CFR Part 820
Quality System Regulation
Medical device design & document history records.
EU GMP Annex 11
Computerised Systems
GMP-regulated manufacturing and quality activities.
ISO 13485:2016
Medical Device QMS
Documentation, including technical file control.
ISO/IEC 27001:2022
Information Security
Management for document repositories and access.
EU MDR / IVDR
Device Documentation
Technical file and post-market requirements.
ICH Q9 · Q10
Quality Risk & Systems
Risk management and pharmaceutical quality systems.
ALCOA++
Data Integrity Principles
Attributable, legible, contemporaneous, original, accurate.
WHO Guidance
Data Integrity
Good documentation practice and data governance.
GAMP 5
Validation
Risk-based validation, including IQ / OQ / PQ.
ISO 14971:2019
Risk Management
Documentation for medical devices.
Implementation
Go live in 6–8 weeks, without disrupting current operations.
A phased, low-risk rollout designed around your validation package and audit calendar with 24/7 support from the first day.
Week 1–2
Discovery & migration plan
Document inventory, gap assessment and a structured cutover plan.
Week 3–4
Configuration & workflow build
Workflows, roles, templates and e-signature rules are configured to your SOPs.
Week 5–6
Validation & UAT
User acceptance testing alongside your validation package, ready for sign-off.
Week 7–8
Go-live & training
Phased go-live with role-based training and 24/7 support from day one.
“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
“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.”
Get started
See KOŚA DMS in your environment.
Book a 30-minute walkthrough with a compliance architect - tailored to your SOPs, your workflows and your audit calendar.
21 CFR Part 11 · EU Annex 11 · ALCOA++ · GAMP 5
FAQs
Frequently asked questions
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 LIMS?+
Yes. KOŚA's document management system for pharmaceutical industry teams integrates with ERP and LIMS 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?+
Yes. KOŚA's document management system for pharmaceutical industry teams integrates with ERP and LIMS 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.