The Devil Was Really in the Details

We were contracted to perform the extensive review of validation documentation of multiple computerized laboratory systems, supporting policies and procedures for the validation process and the overall IT infrastructure. The management of the company sensed that something was not in synch but could not put its figurative finger on the problem.

At a first glance, everything looked adequate. Expected documentation - functional requirements, traceability matrices, protocols, reports, test scripts, etc. - was available, policies and procedures were in place and quality assurance involvement was in evidence, and all the documents and records were signed and dated.

However, we realized that serious issues existed when we started looking at details of the records. For example: there was no logical flow to the validation process; certain activities were duplicated; a phased approach was used that effectively precluded the ability to trace testing back to requirements; there were no criteria for the review/approval process; and the Quality Assurance Unit's input was not timely nor did it address regulatory compliance. In addition, the system testing did not adequately confirm that selected regulatory requirements were sufficiently met, and some systems were released for production use with regulatory compliance issues unresolved.

The results of our overall assessment were none too flattering for the validation and Quality Assurance groups. However, the executive team was quite appreciative of our visit because, in a short period of time, we identified significant regulatory and business issues and provided pragmatic recommendations for improvement in three areas: validation process, change control process and Quality Assurance oversight.

Practically speaking, existence of SOPs and a set of documentation do not necessarily mean that your company is in regulatory compliance. We will help you identify gaps in your operations and work with you to enhance your regulatory compliance status and increase your business effectiveness and efficiency.