The FDA’s 21 CFR Part 11 standard that came into force in 1997 describes how to handle electronic data during the validation and inspection of facilities and processes in the pharmaceuticals, cosmetics and food industries. Explicit regulatory requirements which describe the demands for quality-compliant Excel spreadsheets in the GxP-regulated environment and the handling of the same in detail is however not found in 21 CFR Part 11.
The situation with GAMP®5 is similar. Even though the guideline for software validation in the pharmaceutical environment presents an open and scalable concept for the topic of Excel spreadsheet validation, it lacks detailed information about the requirements that must be taken into account in preparing a quality-assured document.
“Due to the rather general nature of the requirements and possible solutions, many users see themselves confronted with several challenges,” says Joachim Englert, Consultant and GMP Expert in IT Validation at gempex. “The requirements for data traceability, integrity and availability keep getting stricter. Quality-by- design is the new buzzword and also the prescribed approach of many relevant institutions.”
In his specialist presentation “Excel spreadsheet validation in the GxP environment”, given by the GMP expert at LOUNGES in Karlsruhe, Joachim Englert discusses the requirements for GMP-compliant Excel spreadsheets and why users see themselves forced to integrate these requirements into a technology that appears to no longer be up to date. The special focus of the presentation is on a pragmatic approach intended to harmonise the regulatory requirements with day-to-day operations. Possible solutions and design recommendations are revealed according to the motto: As little as possible, as much as necessary.
Excel spreadsheet validation in the GxP environment
Joachim Englert, gempex GmbH
29 January 2019 | 3:30 pm | Room 3
dm-Arena, trade fair Karlsruhe
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Registration code: SA0PZZFZ (gempex booth D1.2)