Validating with DataTrace
DTPro Software revisions may occasionally be needed to add functionality, fix issues, or remove obsolete aspects.
To ensure that our updates meet FDA 21 CFR Part 11 and our own requirements, the software validation effort is a tightly controlled process. Major updates to the DTPro Software require that the software specifications be revised. These specifications inclue:
- Validation and Compliance Plan – Defines the validation strategy, responsibilities, and deliverables of the validation effort.
- Functional Requirement Specification (FRS) – Details the capabilities and functionality of the DTPro Software and is used as source material to create the validation protocol.
- Configuration and Design Specification (CDS) – Describes the elements, functions, and configuration of the DTPro software that are required to meet the items detailed in the Functional Requirement Specification. This specification is also used as source material to create the validation protocol.
- Requirement Traceability Matrix – Summarizes the overall validation effort. Details the locations in the protocols where specific testing was completed. This document is updated after the validation testing has been completed.
Once the specification documents have been revised (if needed), the validation protocol can be created. This protocol includes testing for any new functionality, and notation of any functionality that was changed. The testing is written so that all aspects included in the update are thoroughly vetted.
The protocol is then reviewed, revised, and approved. The approvers include personnel from Mesa Labs’ engineering, manufacturing, validation, product management, and quality departments.
The personnel completing the validation protocol testing are responsible for ensuring that all testing prerequisites are met before the testing is initiated, are familiar with the testing that is being done, completing all protocol entries per Mesa Laboratories GDP requirements, accurately documenting the testing results, verifying that the test results met the defined acceptance criteria at the time of testing, and initiating deviations for testing that fails to meet the defined acceptance criteria.
Any failures or issues encountered during the validation testing are documented by creating a Deviation. The Deviation documents the details of the failure or issue, the investigation into the cause of the failure, the corrective action taken to resolve the issue, retesting of the test step(s) (if required), collects any supporting documentation for the corrective action, and the approval of the actions taken to resolve the Deviation.
When all testing has been completed and all deviations have been resolved, the completed protocol is then reviewed, any errors corrected, and a report summarizing the results of the validation testing created and approved by the same personnel the originally approved the validation protocol. After the summary report has been approved, the new DTPro Software version is then released for use.
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