Stability Testing

LAB+ | Stability testing

LAB+ | Stability testing

Ongoing stability tests are standard tasks in pharmaceutical laboratories. The corresponding module in MAQSIMA LAB+ offers the software-side solution for the planning, management and performance of stability tests. Through the secure access protection and comprehensive audit trail functions, the module meets the strict GMP and FDA guidelines.


This way, the module ensures efficient testing and documentation. In this context, it is important that scheduled dates can easily be identified and tracked and that comprehensive planning of the resources is possible.

 

Module: LAB+ I Stability testing - precisely coordinated

  • clear structure of test orders, storage, test procedures and scheduled dates
  • quick definition of time spent regularly and the test procedures
  • clear definition of responsibilities
  • flexible adaption options within the runtime
  • fully integrated sample warehouse management
  • calculation of required samples and inventory control
  • extensive concepts for capturing measurement values
  • signalization of tolerance deviations
  • flexible data analysis
  • convenient creation of stability reports (also during the runtime)
  • barcode-controlled relocation and posting of stability samples

Requirements for the LIMS:

Analysis and calculation of the shelf life according to ICH Q1A (R2) and Q1E
Trend evaluation of release parameters (batch-dependent across defined area)

  • Implementation with LAB+ | Stability testing