The only way to reduce or replace the use of external tools for results entry and calculation is to have an ERP system that allows for the management of analytical specifications and the results entry process, addressing industry requirements and lab needs.
D365 F&SCM test groups represent product specifications (document checks, analytical tests, etc.). Test groups consist of:
A header defining the specification name, description, item sampling, and status to be assigned to batches when quality orders are closed successfully or with a failure (optional);
Lines that represent the set of tests to be performed on a batch or sub-batch with the relative acceptance criteria.
Life Sciences Quality Control & Assurance integrates test groups with specific functionalities to address common industry requirements and GMP guidelines, including test group versioning, result ranges, precision, result evaluation methods, the approval and activation of specifications, and the definition of customer specifications.
Test groups are set up in Life Sciences Quality Control & Assurance > Setup > Quality Control > Test groups.
Life Sciences Quality Control & Assurance provides additional features related to the Test group header and lines, including:
Header
Test group versioning
Reduced test group
Quality scheduling
Customer-specific setup
Test group approval and activations
Note
The Reduced test group is an optional information. If it is defined in the test group, its value is then defaulted in the quality association; otherwise, its value can be manually inserted in the quality association if needed.
Lines
The capability to assign a criterion to a test group line.
The capability to manage internal specifications: results are also validated against internal specs.
The capability to define rounding rules for test specifications.
The capability to define, for fraction tests, the relevant decimal precision for the test specification and for results entry, overwriting the default precision defined for the Unit associated with the test.
The capability to set only a minimum or maximum value for a specific test and to indicate ranges. This covers test specifications like “Each result should be greater than or equal to the minimum value” or “Each result should be less than or equal to the maximum value”.
The capability to define trend control setup.
The definition of the evaluation method for each test group member.
The capability to mark a test as Reduced.
The capability to define a test as Optional.
The capability to overwrite the default test method and calculation formula (if any).