How compliant are you with 21 CFR Part 11?

An ABB Engineering Services product story

Edited by the Engineeringtalk editorial team Aug 19, 2003

A recent - and soon to be repeated - seminar hosted by ABB Eutech Process Solutions addressed the full implications of compliance with the US FDA's 21 CFR Part 11 regulations.

ABB Eutech Process Solutions held a seminar recently to discuss exactly that.

This well attended seminar covered a topical subject, as the recent "revolutionary" Food and Drug Administration (FDA) guidance on 21 CFR Part 11 has been widely misinterpreted, and is much discussed by affected parties.

The delegates heard from a mixture of industry, suppliers and consultants that a well-documented and objective risk based approach will minimise the regulatory risks with the optimum cost.

Time and again, the key message was "stay risk-focused while adopting practical methods for dealing with Part 11".

In addition to a Part 11 regulatory update, the seminar participants learnt about FDA's risk-based initiative to GMP, process analytical technology (PAT) developments and electronic data archiving (EDA) requirements and issues.

In this context it is worthwhile to point out the new Special Interest Group (SIG) on EDA is run by ABB under the GAMP Forum initiative.

More information can be gained from www.ispe.gov.

Industry speakers from Amersham, AstraZeneca and Pfizer raised many valuable learning points.

A risk-based approach has in many cases already been implemented, and is demonstrated to be the correct way forward.

The regulatory noncompliances of Microsoft Excel were explored.

This was a "hot topic", considering the wide use of Excel spreadsheets in industry and clear deficiencies with regard to security, audit trails and electronic signatures.

ABB has addressed this situation by providing solutions based on risk reduction for the minimum effort and cost.

These solutions involve carrying out a simplified risk assessment, a standardised validation approach, and the application of a fully compliant, yet economical and easy to use addon package (DaCS).

An appreciated afternoon session dealt with risk assessments in general (using the well established approach of identify, assess and resolve), as well as how "filters" can be used to drastically reduce both the scope and residual risks for any Part 11 project.

The seminar finished with a case study for a risk based approach to project management.

This used an ABB developed spreadsheet that enables rapid and effective prioritisation and justification of scope and content for a Part 11 project.

Standardised "tools" for dealing with common Part 11-related deficiencies were also shown.

All in all it was a very successful day.

"The seminar brought together the topic of 21 CFR Part 11 in a logical way, and provided a valuable approach", was just one of the many appreciative delegate comments, "Well informed with useful content in every session", was another.

Due to its success, this seminar is to be repeated later this year.