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.