As a result of a recent audit, a large pharmaceutical manufacturer needed to improve its laboratory equipment qualification process and address software validation for instrument workstations. CSA Soliance was brought in to address these issues and help the laboratory get into compliance for an upcoming follow-up audit. After recognizing that the IQ/OQ packages purchased from the client’s instrument vendors were inadequate, CSA Soliance helped the company establish instrument and software requirements. A risk assessment was utilized to establish software requirements that cover all systems such as data security, audit trails and electronic signatures.
A qualification “wrapper” process was developed and secondary protocols created based on the laboratory’s requirements. This approach was flexible enough to reference meaningful tests in the OEM protocol while adding additional testing as necessary. This approach had the added benefit of combining software testing with instrument qualification which saved significant time and cost over performing these validations separately.