Zamann Pharma Support was engaged by a German pharmaceutical manufacturer facing recurring equipment qualification gaps.
The company had extensive IQ, OQ, and PQ documentation. However, EMA inspectors questioned the testing logic, while FDA reviewers could not clearly confirm that the equipment was fit for intended use.
Our assessment found the root cause: incomplete, vague, or missing User Requirements Specifications (URS).
Because URS defines intended use, these weaknesses affected testing, traceability, data integrity, and qualification decisions.
Our team assessed the qualification environment, identified the URS gaps, and defined a remediation approach.
Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.
Creating the URS after equipment purchase, installation, use, or qualification creates a major weakness. The source identified post-purchase URS creation as an FDA inspection concern. It also prevents the URS from guiding equipment decisions and defining intended use before qualification starts.
The source identifies audit trails, access control, backup and restore, electronic signatures, alarm handling, and data transfer validation. It also recommends defining user roles, metadata, raw data preservation, system security, and alarm logging when developing the URS.
A vague requirement cannot provide a measurable acceptance criterion. Therefore, qualification tests cannot reliably verify it. This can make IQ unclear, cause OQ to miss critical functions, prevent PQ from demonstrating intended use, and create gaps or “N/A” entries in the traceability matrix.
