Manage all Aspects of Stability Studies
  • Stability manages the day-to-day activities of the stability department within the quality control and/or R&D divisions, and is designed for all types of products, from pre-clinical to post market, innovator or generic.
  • Product Registration: the user inputs information regarding sample’s location, storage conditions, testing intervals, labels, and includes custom fields used to suit your information control needs.
  • Protocol: is where the user can define the required tests, workload, costs, department or external labs, sample and unit amounts, and detailed comments relating to each test.
  • Summary: used for entering, verifying and approving test data, adding or deleting intervals. 
  • Inventory control: used to monitor all inventory within the system, remove specific samples from the test group, offers system wide sample information based on the selected product.
  • Statistical Trending: of lots using linear regression in a graphical display is provided to ensure the manufacturing process is under control.  An advanced statistical package is included witch offers a p-value and Arrhenius equation calculations.

Extensive, independent audit trail: is provided for all key windows, tracking all creation, modification and deletion of data within the system.

 





Copyright Novatek Europe   |   tel: +44 (0) 20 8834 1387  |   info@novatekeurope.co.uk
Back to top ^  |  Print this Page