Beyond Digitisation: Evaluating Electronic Records and Signatures in Pharma Software

Moving pharmaceutical documentation from paper to electronic systems can improve accessibility and workflow management. However, digital records introduce important questions about identity, traceability, security and long-term availability.

For teams developing, configuring or implementing software in regulated pharmaceutical environments, 21 CFR Part 11 is an important regulation to understand.

It covers electronic records and electronic signatures within its scope.

Here are some practical questions to consider when evaluating a system:

Can the system generate accurate and complete copies of electronic records?

Are electronic signatures uniquely associated with individuals?

Are signatures permanently linked to their corresponding records?

Does the system maintain secure, time-stamped audit trails?

Can access be restricted according to user authorisation?

Can records be retrieved throughout their applicable retention periods?

Is there documented evidence that the system performs as intended?

These questions connect software functionality with regulatory and operational expectations.

Implementation teams should also consider configuration management, validation, testing, supplier documentation, change control and user training.

A common misconception is that selecting a product labelled Part 11 compliant is enough. In practice, compliance depends on the system's intended use, configuration, validation and the organisation's procedures.

This https://incepbio.com/blog/21-cfr-part-11-compliance-software/ explains the seven key areas and their associated regulatory provisions.