Pharmaceutical manufacturers are legally obliged to 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. versiondog helps companies adhere to FDA and GxP rules with regard to process quality, production documentation and proof of compliance.
versiondog for the pharmaceutical and chemical industries
Audit trail – complete documentation of control program changes
- 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
Change management with easy application of the two-person rule
- 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
Version management – detection of changes to released control programs
- Ensure clarity and certainty in production
- Detect unauthorised changes
Archive manager for long-term archiving of data
- Automatic documentation of all project data for Product
Lifecycle Management (PLM)
Customers from the pharmaceutical and chemical industries use versiondog to:
- Centralise the change management of project data
- Backup device data automatically
- Automate documentation and always know WHO changed WHAT, WHERE, WHEN, and WHY
- Ease coordination when operating multiple shifts
- Quickly modify production processes for product variations
- Ensure consistent quality
- Save time and money in all production facilities
Always happy to help you
My name is Aaron Abelmann, your central contact person - available to you 24 hours a day!
No matter whether you have questions, need information about versiondog, or want to make an arrange a Web-Demo, I am here to help you.
Your virtual contact person
Aaron Abelmann
T +49 6341 6810-300
aaron.abelmann@auvesy.de
Contact me on LinkedIn