Facility Implements FileTrail for Audit-Readiness
Background
Manufacturing and testing records provide the bedrock of evidence that pharmaceutical companies have followed GMP. The ability to track and quickly retrieve documentation as needed to investigate trends, issues and complaints — and complete regulatory audits — is critical over the lifecycle of a product.
This organization’s Midwest facility had been using a custom-built database for its Record Center over a period of 15 years. Over time, it had become apparent that the aging system was unable to scale to support the amount of data that the site was processing on a daily basis.
To address this, the Quality Systems team had added ancillary tools — including spreadsheets, Access databases, and other forms — to supplement the primary database.
“The other issue was that this was a site-specific system, and we were relying heavily on individuals who had historical knowledge of how it worked. We decided to look for a new system that could be supported at the global level by IT support — particularly as our company as a whole is working toward more standardization of systems.”
A Manual Process
On average, the Midwest Record Center receives 2,500 documents each month — batch records, Certificates of Analysis, logbooks, notebooks, calibration documentation, validation documents for equipment and more — plus one-off items that arrive in binders.
Under the previous system, information about each docu-ment needed to be entered manually by staff at least three times into three different systems — including multiple spreadsheets in addition to the primary database — before getting filed away onto a shelf within the Record Center.
Retrieving an item from the Record Center required an initial step of trying to find where it was likely to have been shelved, confirming its location, and then updating forms and spread-sheets to check the item out. “We were spending a lot of time duplicating efforts. It was a completely manual process,” says the Project Delivery Manager.
