FDA Addresses Part 11

Changes should significantly reduce the scope of compliance requirements at medical gases firms.

Over the last decade, the medical gases community has become accustomed to a seemingly constant escalation of FDA compliance requirements. A recent reversal in FDA’s thinking on electronic records and electronic signatures promises to simplify some requirements for medical gas producers, and is a welcome change.

The requirements governing electronic records and signatures are known as 21 CFR, Part 11, and are usually referred to simply as Part 11. Introduced in 1997, these rules were intended to foster the widest possible use of computer systems in drug development and manufacturing and avoid putting unnecessary cost-prohibitive burdens on industry.

System and software validation has been one of the biggest and most expensive barriers to adoption of computer and software technology for medical gas producers. FDA just opened the door to 21st century technologies in the medical gases arena.

Unfortunately, the implementation and enforcement of these regulations by FDA had precisely the opposite effect. When faced with bringing their electronic data and record keeping systems into Part 11 compliance, many medical gas firms chose to either remain with, or in some cases return to, a paper-based record system. With high implementation costs and complicated regulatory issues, Part 11 has been a significant roadblock to implementation of new, computer-based technologies in the medical gases industry.

FDA faced up to the problems with Part 11 and, in September 2003, published new guidance for Part 11 compliance entitled Part 11, Electronic Records; Electronic Signatures – Scope and Application, which introduces a new direction to FDA thinking on Part 11 compliance.

A key provision in this new guidance is the adoption of a more narrow interpretation of the scope of Part 11. Now, only those records that are mandated by GMP fall under these requirements, which for medical gas producers translates to lower implementation and system maintenance costs for Part 11 compliance.

A second provision of FDA’s new narrow interpretation concerns how records are maintained. Up to this point, medical gas firms that kept records electronically, even if paper copies were used to conduct ongoing activities, had to comply with Part 11. Now, if your paper records meet all GMP requirements, and you rely on those paper records to conduct your “regulated activities,” you do not need to comply with Part 11 even if you also maintain electronic copies of GMP records. This is a major change and should significantly reduce the scope of Part 11 compliance requirements at medical gases firms. This change should facilitate the implementation of new technologies like cylinder tracking and electronic data capture. In the future, FDA will inspect a firm’s business practices to determine how records are managed and base potential compliance actions on actual company business practices, not written policy.

FDA announced in the new guidance document that they intend to exercise regulatory discretion with regard to Part 11 requirements for validation, audit trails, record retention and record copying. Firms are warned to take adequate steps in guarding the integrity of electronic records and apply appropriate controls that ensure records cannot be changed or altered in a manner that would leave no trace.

Risk Assessments
FDA “suggests” that any decision to validate, and the extent of any system validation, be based on and justified by a documented risk assessment. Risk assessments should account for the potential to affect product quality and safety as well as the impact on record integrity. System and software validation has been one of the biggest and most expensive barriers to adoption of computer and software technology for medical gases producers, and this change further opens the door to 21st century technologies entering the medical gases arena.

These risk assessments will form the cornerstone of your decision process for Part 11 compliance. We highly recommend that firms conduct a thorough and appropriate initial risk assessment and justification. Spending a relatively small amount of time and effort at the onset of the project will help to ensure that an FDA inspector cannot pick your decisions apart during an inspection and expose your company to a future regulatory action. Even if you decide your system does not fall under Part 11 requirements, you should have a risk assessment to back up this decision.

Legacy Systems
New provisions for legacy systems is another of the areas in which FDA intends to exercise regulatory discretion. Electronic record keeping systems will be excluded from the requirements of Part 11 through FDA regulatory discretion that…

  • Were operational before August 20, 1997
  • Met the applicable requirements at the time
  • Meet current applicable mandated GMP record requirements, and

Have documented evidence and justification that the system is fit for its intended use (including an acceptable level of record security and integrity).

Since FDA is exercising regulatory discretion does not mean that they will not change their mind at some point in the future. FDA cautions that systems that have been modified or upgraded after August 1997 could become subject to Part 11 under certain conditions. Decisions on Part 11 compliance for legacy systems which incorporate mandated GMP records should be based and supported by a risk assessment.

New Rules Coming
Over the coming months, the medical gases industry can expect to see FDA initiate new rule making to harmonize Part 11 with their current thinking and eliminate the need to exercise regulatory discretion. While FDA has made it easier to comply with Part 11, there are still regulatory and technical issues and challenges that firms must navigate through. GAWDA’s voice will be heard during this process.

Gases and Welding Distributors Association
Meet the Author
J. Robert Yeoman, GAWDA’s FDA and medical gases consultant, is managing director of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania.