Data management for the pharmaceutical and life science industry
Pharmaceutical and life science manufacturers must comply with a range of regulations and standards, such as FDA and GxP. This requires full and detailed documentation of the entire production process and of regularly conducted self-inspections. Each manufacturing step, every organisational measure and all process conditions must be documented end-to-end to provide full records and complete traceability. octoplant help companies adhere to FDA and GxP rules with regard to process quality, production documentation and proof of compliance.
More than 2,500 customers worldwide successfully optimize their maintenance with AUVESY-MDT
Key Features
Audit trail
- Save time due to standardised documentation
- Simplify complex auditing tasks
- Replace paper-based documentation systems
- Generate audit trails at the click of a button
- Ease adherence to standards, including FDA 21 CRF 11 and GxP
Version management
- Detect changes to released control programs
- Ensure clarity and certainty in production
- Detect unauthorised changes
Change management
- Ensure that the two-person rule is followed
- Ease adherence to other QM rules
- Keep an unbroken change history of all manufacturing processes
- Reduce personal liability
- Avoid serious consequences caused by simple, easily-made errors
Archive manager
- Archive manager for long-term archiving of data
- Automatic documentation of all project data for Product Lifecycle Management (PLM)
Why do so many companies in your industry use our products?
End-to-end documentation of all manufacturing processes
Smooth workflow when using the two-person rule
Tailored to FDA and GxP requirements
Worth Knowing
Discover what AUVESY-MDT can do for your business
Whitepaper: Prevent production downtime effectively by monitoring intelligently
Have you ever asked yourself one of these questions regarding your company’s production processes?
- How can production management avoid disruptions in complex environments?
- Which modern software solution functions help avoid or repair data loss, downtimes and misconfigurations in the shortest possible time?
- How does central documentation of all systems and processes ensure faster induction and problem solving?
- How can modern production plants be automated, monitored, and protected?
If so, you should download our latest whitepaper.
This free white paper is for plant managers facing the challenges of digital production processes.