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. versiondog and AutoSave help companies adhere to FDA and GxP rules with regard to process quality, production documentation and proof of compliance.
- 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
- Detect changes to released control programs
- Ensure clarity and certainty in production
- Detect unauthorised changes
- 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 for long-term archiving of data
- Automatic documentation of all project data for Product
Lifecycle Management (PLM)
A firefighting mentality is one where organizations are frantically rushing to solve unexpected problems, making impulsive decisions, and applying short term “band-aid” solutions to restore production as quickly as possible. Production plants are particularly susceptible to this mentality. Why? Plants are up against a wide variety of risks to productivity and product quality. Human error, equipment failure, cyber attack, and natural disaster all have the potential to cause significant downtime. When every minute of downtime can cost thousands, it is critical to resume production as quickly as possible.
Nevertheless, very few production plants are adequately prepared for worst-case scenarios or even everyday issues. A proactive approach to data management for automation could save time, money, and effort.
This white paper will discuss how better data management can transform your industrial automation for increased productivity with fewer problems. First, it will explore the causes and concerns of a reactive “firefighting” approach to maintenance in automation. Then, it will propose data management tools and best practices to help break these habits.