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.
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
Validation in regulated sectors
The US Food and Drug Administration (FDA) imposes strict requirements on owners and operators of production facilities in regulated sectors. Manufacturers in these sectors, such as pharmaceutical companies, for example, are only permitted to produce goods in authorised facilities that are Good Manufacturing Practices (GMP) compliant. The same applies to software systems installed on devices used in such production facilities.
You can find out more about the validation process of software systems being used in regulated sectors and discover how a software provider can help support pharmaceutical companies during this validation process, in our technical article: "Validation in regulated sectors".
What can we do for you today?
If you have any questions at all about versiondog or want to arrange an individual web or on-site demonstration, then we will be delighted to hear from you!
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