Note
This feature is deprecated. See: Release 10.0.47.44 (March 2026).
Many pharmaceutical manufacturers face the challenge of balancing the need to comply with customers’ and regulatory requirements and the need to sustain flexibility across the supply chain.
Life Sciences Quality Control & Assurance enables the definition of one or more customer-specific setups for a test group so that the same product can be used for different customers and show customers’ specifications on Certificates of Analysis/Conformity. Users can configure a Customer-specific setup from the Test groups form if customer specifications need to be tracked and printed in the Certificate of Analysis.
Once the Customer-specific setup button is clicked, users can work with a form to define the variances to be applied to the Certificate of Analysis/Conformity for a specific combination of the test group, customer, and item. For example:
If a test included in the test group must be excluded from the tests displayed in the Certificate of Analysis/Conformity for that item/customer, the Action field will be set to Exclude.
If an additional test should be included in the Certificate of Analysis/Conformity for that item/customer with different limits, the Action field will be set to Include. By enabling the Change checkbox, it is possible to modify the test specifications.
Example
Test group “TG637_001” includes test 10, Appearance, and test 20, “ph”.
Customer-specific setup for test group “TG637_001”, item “001”, and customer “CST001-01” is set to:
Exclude test 10, Appearance.
Include test 20 “pH” with a different max value:
Max value is set to “5.00” for the internal test group.
Max value is set to “8.00” for the customer-specific test group.
When the Certificate of Analysis/Conformity is created in Life Sciences Quality Control & Assurance > Inquiries > Quality management > Certificate of analysis, the user can select the customer account to recall the customer-specific setup for the selected item.
Note
Starting with version 10.0.45, Microsoft has introduced the “Advanced Quality Management” feature, which incorporates the Customer COA requirements functionality. This new standard functionality overlaps with the process previously described. When the “Advanced Quality Management” feature is enabled in Feature management, the STAEDEAN Customer-specific setup button will be unavailable, and the corresponding Microsoft functionality should be used instead.