Document Management (Core)
Document Management (Core)
Document management without media breaks: Create, Approve, Sign.
SOPs in Word, approvals by email, signatures via DocuSign and the version history in an Excel list: in many biotechs and CROs, document management is spread across half a dozen tools. This costs time, creates sources of error and becomes a risk by the next inspection at the latest. Docuply eDMS Core brings the entire lifecycle of your GxP documents together on one platform, from the first draft through approval to periodic review.
In the integrated document editor, you work together and in parallel on document versions, comment on content and tag colleagues directly in the text. Content and layout templates ensure consistent documents and can themselves be edited with full traceability. The AI features support you whenever you need them: select a section or the entire document and have content translated, summarised, expanded or simplified via a prompt. Processing takes place exclusively on European servers (EU27) in accordance with ISO 27001. When you finalise a new version, Docuply also automatically suggests a description of the changes for the change history.
Once a document is ready, you start a freely configurable approval workflow, either sequential or parallel. Every approval step is confirmed and electronically signed in accordance with 21 CFR Part 11. You can use electronic signatures compliant with 21 CFR Part 11 and eIDAS (AES/AdES) in unlimited numbers, with no quotas or per-signature costs.
Particularly convenient: external partners such as trial sites, CROs, suppliers or consultants can also sign directly in Docuply without needing their own account, naturally also in compliance with 21 CFR Part 11. This allows you to replace DocuSign, Adobe Sign and similar tools entirely and keep signed documents where they belong: in your validated system.
For SOPs and other living documents, you can activate a periodic review on a per-document basis, so no review date is ever missed again. Document linking lets you connect related documents, and a complete audit trail records every document and system change. The result: fewer tools, less coordination effort and documentation that is inspection-ready at all times.
You can find more about data protection and information security in our Trust Center.
- Unlimited electronic signatures: In accordance with 21 CFR Part 11 and eIDAS (AES/AdES), with no quota and no cost per signature
- Signatures by external parties without an account: Third parties sign directly in Docuply, also in accordance with 21 CFR Part 11
- Replacing DocuSign, Adobe Sign and the like: Signed documents directly within one validated system
- Fully customisable approval workflows: Sequential and parallel approval processes tailored to your roles
- Signed approval steps: Each step is validated in accordance with 21 CFR Part 11 and electronically signed
- Periodic reviews can be set up for each document: Automatic reminders for reviews due, for example for SOPs
- Collaborative document editor: Work on document versions simultaneously without having to send files back and forth
- Content and layout templates: Consistent documents; templates can be edited whilst retaining version history
- AI in the editor: Translate, summarise, rephrase or simplify content or sections using a prompt
- AI suggestion for the change history: Automatically generated description of each version change
- AI processing in the EU: European servers (EU27), ISO 27001-certified; see the Trust Centre for details
- Comments and mentions: Discuss directly within the document and tag colleagues
- Document linking: Link related documents and highlight dependencies
- Complete audit trail: All document and system changes are fully logged
- The platform’s foundation: Seamless integration with Training Hub, Quality Events, Supplier Management and TMF
- Designed for clinical biotech companies and CROs: GxP-compliant for GCP and GMP environments
Book a live demo and see for yourself how you can create documents collaboratively, approve them via an approval workflow and sign them with internal and external partners in accordance with 21 CFR Part 11 – all on a single platform. This allows you to replace Word files, email chains and separate signature tools – ensuring your documentation is always audit-ready.
Testimonials
What experts say about us
"Docuply takes the stress out of audits and inspections by keeping everything in one place. It simplifies things for pharmaceutical teams and allows them to focus on what matters. Having seen how time-consuming and anxiety-inducing traditional audit preparation can be, I’m excited to support a tool that brings simplicity, transparency and real peace of mind to compliance."
