Common Validation Mistakes: lessons-Learned by a GxP Consultant
Improving the quality of validation documentation seems more time-consuming than it truly is. This blog provides a quick overview of common mistakes and potential solutions.
To give a glimpse on how to avoid the most commonly mistakes; Specify, Clarify, Review and Verify.
Ambiguity & Vague Wording
Words such as any, some, or, either are ambiguous whereas approximately, possible and may are considered vague. Depending on the context, ambiguous and vague words are open to interpretations and can introduce uncertainty or lack of specificity when setting up e.g., requirements.
One such example - when pre-defined templates are used to validate a process, be aware of vague phrases that could be generally used for a variety of systems (one size fits all templates). For instance, “System must meet the regulatory requirements / in accordance with the approved procedure” phrase should provide explicit information on such regulation and the related requirements.
To avoid Ambiguity & Vague wording, choose strong descriptive words and those with a clear and definite meaning. When using templates, adopt general sentences only after incorporating specific details. Keep in mind, Validation documents sporting such ambiguities could also prove challenging in the context of audits/inspections.
Lacking details
Requirements and specifications must contain adequately described details or characteristics. Lacking details could cause complications to prove intended use of the system. Poorly specified requirements introduce uncertainty or lack of specificity which will raise questions or lead to poor-quality test results.
Clearly outlined requirements are established through a good understanding of the process (system’s intended use). Include sufficient details to limit the interpretations to only one.
Missing information
Missing information or records with fundamental information is another common validation issue but is challenging to intercept. Missing data could be a result of not clearly outlined deliverables or unknown/ignored data.
Include all (fundamental) information: as supporting documentation and source references necessary to your validation project. Review and verify the documentation regularly.
Unverifiable Results
Results must be verifiable by an independent reviewer and remain confirmable over an extended period after validation. Requirements and test results that are not clearly defined or documented could be unverifiable or irreproducible.
Document detailed results on the process and document if extra steps were needed to come to the results (ad-hoc testing). All results must have a corresponding verifiable evidence, most common practice is to provide a timestamped screenshot. Especially, in case of hardship for recreating the results. Remember – when it is not documented then it is not done!
Inconsistency
Inconsistency may occur between statements discussing the same topic within a single document or between documents in the same validation package. When the validation processes include several documents, ensure consistency in the content and format across all documents.
When a validation is extended over a longer period or includes multiple documents or writers, make sure to retrospectively verify that (new) insights remain consistent across the documentation.
Traceability
A traceability matrix needs to be in place for documented evidence of the relationship between requirements and test cases and vice versa. Traceability can also expand to change and deviation control and document management of life cycle documents (e.g. version control, audit trail).
Most common traceability issues/mistakes are: 1) the traceability matrix overlooks a traceable specification, and/or 2) an observation record in a test script is missing and/or 3) For some requirements, supplier documentations are referred as verification evidence but lacks such detail and/or 4) Requirements lack corresponding test steps, or conversely, the test script is not linked to a requirement.
Define the steps in the traceability process. Review, verify and update the traceability frequently and align with the documentation package to maintain consistency.
In conclusion to avoid common validation mistakes:
- Ensure a good understanding of the business process that needs validating.
- Specifying details & information.
- Clarifying any ambiguity or vagueness.
- Reviewing to ensure constant traceability.
- Verifying results and their reproducibility.
Streamline your Validation Process: How Rescop addresses common GxP challenges
Understanding the common pitfalls in GxP validation, as outlined in our article, is crucial for maintaining compliance and ensuring quality in validation documentation. Rescop's services are specifically designed to address these challenges head-on. By emphasizing specificity, clarity, and thoroughness, we guide our clients away from ambiguity, inadequate details, and inconsistencies.
Our expert consultants ensure that your validation processes are not just compliant but also optimized for success, offering tailored solutions that include meticulous review, verification, and the maintenance of a comprehensive traceability matrix. Partner with Rescop to elevate your validation efforts, leveraging our expertise to avoid common mistakes and achieve excellence in validation practices.