Quality · Pharmaceutical Industry Practical Discussion

How are quality and regulatory requirements incorporated into technology implementation?

Building compliance into requirements rather than testing it in at the end.

DGXPComplianceLab Editorial Team07 Jul 20262 min read

• Concept
• Practical example
• Process
• Documentation
• Technology
• Quality considerations
• Example use case

01Concept

Regulatory expectations — access control, audit trails, signatures, data retention — should appear in the user requirements. If they are added late, they are usually expensive and incomplete.

02Practical example

A URS for an HMI specifies unique logins, role-based permissions, audit trail of parameter changes and time synchronisation, so the vendor designs them in.

03Process

1. 1

   Identify applicable regulations

2. 2

   Translate into requirements

3. 3

   Assess risk

4. 4

   Design controls

5. 5

   Verify through testing

6. 6

   Maintain through change control

04Documentation

• Regulatory assessment
• URS
• Risk assessment
• Test evidence
• Change control records

05Technology

Systems with configurable security and audit trails reduce custom development.

06Quality considerations

Quality unit involvement from the requirements stage prevents late rework.

07Example use case

Adding data-integrity requirements at URS stage removes a planned post-installation remediation.

Example use cases are illustrative. This article is general educational information, not regulatory or legal advice.