Docuply
The electronic quality management system with a fully integrated eTMF – for clinical biotech companies on the cusp of, or currently in, Phase I and II. Pre-validated, immediately ready for use and with secure hosting in the EU cloud. The result: no more stress over audits and inspections.
As a tailor-made electronic quality management system (eQMS) with a fully integrated eTMF, Docuply is the ideal solution for small and medium-sized organisations involved in clinical drug development – specifically for these two types of company:
Clinical Biotech Start-Ups & Scale-Ups
Docuply offers clinical biotech companies on the verge of, or currently in, Phase I and II a ready-to-use, pre-validated eQMS with a fully integrated eTMF – at attractive pricing. The intuitive user interface requires no lengthy training, and the Training Hub makes it easier to onboard new staff. Repetitive tasks are automated using practice-proven AI features, leaving more time for qualitative decision-making. In short: the eQMS with a fully integrated eTMF that keeps pace with your momentum.
Contract Research Organisations (CROs)
Docuply optimises quality and data management for small and medium-sized CROs (up to 50 staff) and ensures consistent audit readiness. Through the eTMF, structured in accordance with the CDISC TMF reference model, you can provide your sponsors with insight into the current status of trial documentation at any time, whilst the seamless invitation of site users and 21 CFR Part 11-compliant signatures simplify day-to-day work. Granular permissions per project and sponsor keep your clients’ data clearly separated, securely hosted and ISO 27001-compliant.
Our mission
With Docuply, we bring QMS and Trial Master Files together into a single validated system, enabling clinical biotech companies and their CROs to collaborate securely – across distributed teams and site boundaries. No silos, no chaotic audits. This leaves more time for what really matters: making the world a little better with new medicines.
Digitise and automate your daily QM tasks with Docuply and benefit from integrated AI functionalities that speed up your tasks by up to 80%.
Compliant document management, lightning fast through cloud technology.
All features at a glance
- Setup and onboarding in ten minutes
- Pre-validated system (IQ & OQ) for immediate use
- EU Cloud with 99.95+% availability
- ISO27001 certified and GDPR-compliant
- GLP-, GCP- and GMP-compliant document management
- Digital signature compliant with 21 CFR Part 11 and Annex 11
- Private blockchain audit trail
- Straightforward inviting of third parties and external users
- Modern encryption for all uploaded documents
- Support for all common document types
- Text recognition (OCR) for most document types
- Trial master files with CDISC reference model
- Centralised management of SOP training and other training courses
- Find your documents easily with the help of tags
- API for seamless integration into your IT landscape (in the near future)
- Find further future features on our product roadmap.
Don't rely on stand-alone solutions for your quality management and use a fully integrated solution with Docuply without the hassle of jumping back and forth between different applications.
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."
Known from
Free Document Management for Start-Ups
Up to 8 users, up to 500 MB and 10 electronic signatures (21 CFR Part 11 compliant) per month are free of charge with no strings attached. Avoid SharePoint patchwork and use Docuply, an easily validatable solution.
News
Here you can find news about Docuply.
Master Files – Autopilot for Trial Master Files, Drug Master Files and all other Master Files
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Do you have any questions or suggestions? Please do not hesitate to contact us.