ISPE lends a hand with electronic signatures

Related tags Good automated manufacturing practice

The International Society for Pharmaceutical Engineering has
launched a new technical publication to help pharmaceutical
companies comply with new regulatory requirements on keeping
electronic rather than paper-based records in the manufacturing
process, such as the US food and Drug Administration's 21 CFR Part
11 legislation

The ISPE's GAMP (Good Automated Manufacturing Practice ) Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures provides guidance on meeting current regulatory expectations for compliant electronic records and signatures, which includes the need for record integrity, security, and availability throughout the required retention period.

This new addition to the GAMP Good Practice Guide Series, developed by the GAMP Forum - a technical subcommittee of ISPE - supplements the existing GAMP 4 Guide for Validation of Automated Systems in Pharmaceutical Manufacture, said the ISPE.

It applies a risk-based approach to the identification, management, and control of electronic records and signatures in a regulated GxP context aimed at the implementation of technical and procedural controls appropriate to the impact of records, and to the risks to those records.

"This approach allows measures aimed at a high degree of integrity, availability, and confidentiality (where required) to be established for records that have a high potential impact on product quality or patient safety, while permitting a less rigorous approach for records of lower impact, or those with lower levels of associated risk,"​ said the ISPE.

The main section of the Guide provides a process by which a regulated company can identify the hazards associated with the use of electronic records and signatures, analyse and evaluate the risks, control these risks, and subsequently monitor the effectiveness of the controls by means of periodic review.

More information about the guide is available at​.

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