Software validation processes have always been important; yet, they acquired a special sense of urgency and added importance following the announcement in August 2010 by the FDA in this regard, in which it stated that it “…will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures – Scope and Application’ guidance (Guidance).” Why this added emphasis on action?
The FDA accentuated its action on software validation processes for two important reasons:
1) in the industry, there were diffuse and subjective interpretations about the understanding and application of Part 11
2) perceptions that this statute could have the effect of restricting the use of electronic signatures and discouraging innovation.
Following this action from the FDA; a series of problems that the software validation processes had, are coming to light of late.
So, which are the most common problems of software validation processes?
The following common problems are being observed in the industry:
• Information gone missing:
• Incomplete details in the requirements documents: This has been true especially in relation to data, key processes that go into the internal software, as well as the interactions of the software with the user
• Necessary detail not found
• Traceability: This was the most important problem found in Part 11. The traceability matrix either did not account for a traceable specification or an observation step in a test script, or was incomplete, or the trace was broken.
• Incomprehensible wording in the documentation
• Several GDP-related bungling
• Difficulty in identifying the impugned documents and records