MicroBiology analysis are frequently subject to observations by regulatory inspectors if not properly managed: not all solutions that are already available on the market cover properly all compliance requirements applicable to pharmaceuticals.
K2Pharma module dedicated to Microbiology can be fully integrated with other quality or process data available in other system module or in external systems that that can be easily interfaced: for instance, you can easily create a new sampling plan as a consequence of process deviation, and when the analysis is completed you can authomatically update the status of this deviation as per the analysis result.
MicroBiology module includes these main features:
Management of Sampling Plan and associated master metadata (Locations,
Departments, Lab personnel , etc.)
• Analysis Planning managemnt
• Analysis Execution management, by pre-defined workflows based on each type of analysis
• Fully customizable Reports
• Trends for sampling locations, rooms, departments etc., fully customizable by the user side
• Alert and reminder management
• Deviation and Quality Issues Management
The module also includes all required features to comply with Electronic Record and Signature Regulation (21 CFR part 11), allowing a complete paperless management of microbiology analysis.
Contact us for more information or to request for a demo.