A User Requirement Specification (URS) is the foundation of procurement in pharmaceutical manufacturing. It ensures that tender specifications align with the needs of the business, regulatory compliance, and operational efficiency.
However, many pharmaceutical manufacturers make critical mistakes when drafting their URS, leading to procurement inefficiencies, compliance risks, and costly project delays.
Here, Kjeld Lund from 14644 Cleanroom looks at the top elements often overlooked in tender specification URS and provide guidance on how to get them right.
1. Regulatory and compliance considerations
What’s often missed:
- Failure to align specifications with global regulatory guidelines such as FDA 21 CFR Part 11, EU GMP Annex 11, and ICH Q9.
- Inadequate focus on data integrity and audit trails.
- Ignoring specific country regulations when sourcing equipment globally.
How to do it right:
- Reference applicable regulations: Ensure that all URS documents explicitly reference applicable global and local regulatory requirements, preventing non-compliance issues down the line.
- Define data integrity requirements: Include specifications for electronic records, user access controls, and automated audit trails to comply with regulations like FDA 21 CFR Part 11 and EU GMP Annex 11.
- Collaborate with compliance experts: Work closely with compliance officers and regulatory specialists to validate the URS against updated guidelines.
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