Docuply provides a quality management system specifically designed for pharmaceutical SMEs and startups, featuring a pre-validated, cloud-based platform that ensures compliance with GLP, GCP, and GMP standards. By automating document management and facilitating communication with third parties, Docuply reduces audit findings by 50% and saves users an average of 32% in daily time spent on quality management tasks.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical SMEs and startups face significant challenges in maintaining compliance with GLP, GCP, and GMP standards, often relying on disparate IT solutions that struggle to interact with external business partners. This can lead to chaotic audits, increased findings, and substantial time spent on quality management tasks.
Solution
Docuply offers a pre-validated, cloud-based quality management system designed to streamline compliance for pharmaceutical SMEs and startups. The platform automates document management, facilitates secure communication with third parties like CROs and CDMOs, and ensures adherence to GLP, GCP, and GMP regulations. By providing a fully integrated solution, Docuply eliminates the need for multiple applications, reduces audit findings, and saves users time on daily quality management tasks. The system's Master Files solution allows users to link documents to the desired master file (TMF, DMF, SMF, PSMF), and automatically updates the master file when a new document version is verified, ensuring continuous inspection readiness.
Target Audience
Docuply is designed for pharmaceutical SMEs and startups that need to maintain compliance with GLP, GCP, and GMP standards, and require a secure, integrated quality management system for document control and communication with third parties.
Features
- Pre-validated system (IQ & OQ) for immediate use
- GLP-, GCP-, and GMP-compliant document management
- Audit trail in a private blockchain
- Secure communication with CRO and C(D)MO third parties
- EU Cloud hosting with high availability
- Encryption of all uploaded documents
- Support for common document types
- GDPR compliance
- Document tagging and text recognition (OCR) for easy retrieval
- Digital signatures compliant with CFR 21 Part 11 and EU Annex 11
- Automated Master Files, including Trial Master Files
- Centralized management of SOP trainings and other training programs
- Open API for seamless integration into existing IT infrastructure