Compliance Use Cases¶
Testing for Regulatory Compliance¶
Test Evidence is in use by organisations within regulated industries as part of their TQM processes to evidence their Verification and Validation (V&V) processes and procedures.
Medical research, pharmaceutical software development, engineering and insurance reserving companies use Test Evidence to provide the recorded evidence of their products’ Operational Qualification (OQ).
The Test Evidence tools lend themselves equally to Independent Verification and Validation (IV&V) as to internal V&V.
While Test Evidence creates a recording archive that may be reviewed from within the Test Evidence suite it can also produce a PDF export of the recording. Our customers archive these PDF documents as formal proof of the execution of their OQ processes.
Manufacturing & Clinical Trial Testing¶
We are supporting Clinical Research Organisations that are subject to HIPAA and who are more directly controlled by the FDA’s 21 CFR Part 11 in the U.S. and, peripherally, Annex 11 in the EU. In addition we support National Institute of Allergy and Infectious Diseases (NIAID) funded Clinical Trial Testing companies when they need to qualify their systems and validate their use for regulatory agencies inspection.
Such organisations’ processes need validating with documented evidence of proper operation and we supply tools that provide a more complete test evidence record while eliminating most of the manual work.
For example: Acceptance testing is performed by following test scripts. We make review and auditing of systems behaviour easier by automatically capturing user interaction and allowing annotation of the captured screen images during the test execution.