Biopharma and CMC
A drug development process creates huge amounts of data and documentation. Extracting insights and providing inference on this information is typically a time consuming, labour intensive process. On top of this, these inferences remain isolated from company wide employee’s in static documentation or siloed spreadsheets.
Opvia cloud offers the single source of truth for your teams wealth of disparate data. Ingest and process data directly into the Opvia using automated data upload and contextualise this data across functions and workflows using pre built templates.
With all data structured, building reports and dossiers for regulatory filings and searching across the system to find the information you require is effortless.
Opvia is the only platform that is flexible enough to adapt to our interdisciplinary company and can later on scale up with us to manufacturing. We can seamlessly track the full lifecycle of our innovations - from a single duck egg cell to the worlds first cultured foie gras product!
Héloïse Coutelier, PhD
Ask a question, or request more information
Workflows for Biopharma
Automated Data Collection
Connect your equipment to your process workflows and automate data processing
Electronic Batch Records
Hold your processes accountable and ensure compliance. Track every step throughout your process with Opvia’s transparent and connected electronic batch record (EBR) solution.
Product Lifecycle Management
Ensure digital traceability and compliant data management across your entire product development processes
Registries
Create Registries and databases of Information for any entity
Resource and Inventory Management
Manage resources, materials and equipment across your entire development and manufacturing process
Sample Management
Never lose track of a sample and its associated data again with Opvia’s Sample tracking solution
Quality Management for Biopharma
1. Document Management
Fed up of loose, uncontrolled documents across your organisation? Are people making changes to archived SOPs? Or Is your document change control process painfully manual?
2. Training Management
Difficulty in knowing whether employees are up to date with the latest protocols or procedures? Looking for one source of truth for all training activities?
3. Corrective and Preventative Actions
Continually guide improvements in the recording and management of quality events. Rapidly increase CAPA turnaround time and transparency by tracing and connecting issues to the processes where they occurred, all in one system.
4. Risk Management
Put compliance and business assurance at the heart of your process workflows, with our integrated, fully connected risk management system
5. Audit Events
Summarise all audit relevant activity and documentation in one centralised location to ensure audit events breeze by