Performing Digital Validation Manually and the Risk to Data Integrity

The need for remote work increased exponentially during the pandemic. Many industries had already embraced digitalization, but the pandemic forced companies and professionals to adapt more quickly.

Companies should have resources such as a validation lifecycle management system (VLMS) to generate and manage the entire validation cycle more efficiently. However, some companies have adopted digital validation but are still executing it manually during this period. Although valid in some situations with some precautions, that does not bring a significant efficiency gain to the validation process, as it is too time-consuming and error prone.

Some companies have incorporated an electronic document management (EDM) system into their routine to generate, index, review, and approve validation documents. Other companies have incorporated electronic signature systems to simplify the review and approval process and have kept the documents on their intranet.

In GO!FIVE?, the review, approval, and test execution are among the many functions available. However, its scope is much larger because the system was built on understanding the validation and qualification flow and its interconnections. We can see this exemplified in the following images.

Here are some risks associated with manually performing digital validation and its impact on data integrity.

Risk Scenario 1:

? Scenario 1: Editing pre-approved test documents to include the evidence and data in the test run.

Risk Scenario 2:

? Scenario 2: Using a single signature for approval of the test phase, not approving its executions in an individualized way, and needing help to identify the failed tests.

Risk Scenario 3

? Scenario 3: Informal email review of validation documents.

Comparison of validation cycles

Validation using a text editor (e.g., Microsoft Word?) is one of the bottlenecks in the regulated industry. This is because all the bureaucracy of the manual validation process remains.

Increased validation efforts are associated with document preparation and execution of testing phases, so rely on validation and qualifications content, including risk scenarios, requirements, and testing, as well as automating activities related to your application, such as document formatting, automatic evidence indexing, incident management, and test management, enables 5x faster validations.

The graphs show the difference in the estimated efforts when comparing the three validation models: with paper, using GED (e.g., Electronic Document Management software), and with the GO!FIVE?

The GED requires less effort when compared to paper. Still, this difference is less significant because, despite streamlining review and approval flows, the system still needs to be built and designed for validations, as is the case with GO!FIVE?.

How GO!FIVE? Contributes to Data Integrity

The ALCOA+ concept of data integrity depends on data attributable, readable, contemporaneous, original, accurate, complete, consistent, durable, and available in paper or electronic form.

Technology has emerged as the greatest ally of transparency and a vital tool for increasing data reliability and integrity.

Now, it is possible to manage and execute validation and qualification projects using GO!FIVE?, a Digital Compliance Platform (DCP), where expert efforts will engage in the assessment of risk scenarios, including mitigations and data integrity items where applicable.

This platform contains pre-ready validations and data integrity assessments, including metadata and raw data considered relevant GxP in computerized system validation projects. You can easily import risk scenarios, requirements, and test scripts from the library that will bring data integrity, access control, audit trail, electronic signature, and more to evaluate the process and data related to systems and processes.

GO!FIVE? helps to increase compliance by complying with FDA 21 CFR Part 11 and enabling data integrity projects within the system, including evaluating paper and electronic records from the customer site.

• Modernize and facilitate the inspection and access to data related to validation and qualification projects
• Automatic, real-time tracking of all changes
• Change history by comparison
• A knowledge base that facilitates sharing of global best practices
• Team empowerment
• Ensuring end-to-end integrity in projects
• The system provides early warning of strange behavior, such as simultaneous access attempts and running documents in a different order from reference guides
• Analyze data in real time and determine the best way to track and mitigate your risk scenarios
• DCP does not allow for retroactive signing
• DCP does not allow the exchange of evidence once the test execution has been approved
• Alert or block execution of test script with related requirement and/or risk scenario with pending review and approval
• Compliance with:
• FDA 21 CFR Part 211, 68, 188, and 192
• EudraLex Vol. 4, Appendix 17, Real-time release, and parametric release testing
• EudraLex Vol. 4, Chapter 4, Guidelines
• MHRA Guidance on GxP data integrity
• WHO Guidance on good practice in data and records management

I hope you enjoyed this article. If you want to know more about our digital validation software and its application, please contact our experts at?[email protected].

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