Medical Device Link.

Originally Published EMDM May/June 2001

Q&A: Valarie King-Bailey

US FDA's rule on electronic records and signatures (21 CFR Part 11) establishes the criteria under which the agency will consider electronic records and signatures equivalent to paper records and handwritten signatures. Complying with the rule, which became law in August 1997, raises regulatory, legal, and economic issues for device manufacturers. EMDM spoke with Valarie King-Bailey, vice president for global marketing at QUMAS (Cork, Ireland), about some of these issues facing OEMs in the digital age.

Valarie King-Bailey

Q: Please tell our readers a bit about 21 CFR Part 11, its purpose, and its scope.

A: 21 CFR Part 11 is part of the Code of Federal Regulations that governs electronic signatures and electronic records for US FDA–regulated companies. In the early 1990s, the pharmaceutical industry came to US FDA and requested that it create a set of guidelines for managing electronic records and electronic signatures. The idea was that the life cycle of routing, reviewing, and approving documents was long, and most of these organizations were using electronic systems for the management of those documents. They wanted a guidance from US FDA on how to use electronic records and signatures in a legally defensible manner.

Q: So the initiative for the law really came from industry?

A: That's correct. Basically, the law provides governance for companies that want to use electronic records and signatures. I stress this because it does not say you have to use electronic signatures. You can still use paper, and FDA will accept it. But if you're going to use electronic signatures, you literally have to send a letter to the US FDA saying "I am using electronic signatures as of this date." Any records created from that date will then be viewed as official electronic records. This is important, because even if you print a record out, the electronic copy is still the official document. If US FDA [reviewers] come to your organization and request a copy of your standard operating procedure for a piece of equipment, they do not want you to hand them a piece of paper; they want you to go to the system and show them the electronic record on-line.

Q: What is the greatest challenge facing device manufacturers when complying with 21 CFR Part 11?

A: Getting data into your system from outside sources is one of the biggest challenges. Companies either have to authorize an outside manufacturer to access their system to put this documentation in, or they have to take the paper copy of it and scan it in. Either that, or they risk even more-stringent requirements.

The other challenge is that in most cases, not all of the subject-matter experts whose electronic signatures are required are actually active users of the system. For example, when you are developing a new device, that's mostly handled in R&D. But in order for it to be submitted to US FDA, the regulatory affairs department needs to be in the process. It's important to have access to Part 11–compliant software throughout your organization.

Q: What are the benefits of complying with 21 CFR Part 11?

A: People tend to think of compliance as the law, and they say "Regulatory compliance isn't going to add a dollar to my bottom line." That's not true. Studies have shown that regulatory compliance is just good business. If you put these controls in place, you will have efficiencies built into your system that will automatically give you a direct bottom-line impact.

Q: Are you suggesting that OEMs should really pay US FDA as an efficiency consultant?

A: Right, there you go! To a certain extent, yes, although Miles White, [CEO]of Abbott Laboratories, would probably beg to differ. There are some things US FDA does that put an undue burden on companies, but if you look at the change control process that it has on electronic documentation, this is just a good, efficient way of managing changes. You've got all the information there in front of you, whereas nobody ever has a complete design history file right in front of them, at their fingertips, where they can go through and get every document. In the paper world, these documents have tended to be scattered among various experts in different departments.

Q: So you see 21 CFR Part 11 as democratizing access to documents?

A: Yes, and it makes sense in other ways as well. Consider the example of sets of products manufactured by the same company. Sets don't vary that much from one to the next, and electronic records allow you to create a template of an entire design history file that can be reused as the basis for another set instead of starting from scratch.

Q: Part 11 currently being enforced? Should we expect virtual audits of European firms from US FDA's desktop?

A: The short answer to both questions is yes. 21 CFR Part 11 is being enforced on a case-by-case basis. US FDA is looking at audits based on each company's history with the agency, and the nature of the system it is using electronic documents for. Warning-letter activity has tripled over the last year, and the agency is issuing them hand-over-fist in reference to Part 11.

Virtual audits are not happening at the moment, but they will come. Consider the work that the Global Harmonization Task Force is doing with electronic submissions. As companies begin to issue more fully electronic submissions, those documents are going to fall under the Part 11 guidance, and it is more likely that US FDA will begin stretching its arms across the pond.

Q: How can companies prepare themselves for compliance?

A: By prepapring a compliance plan. Look across your organization and identify those systems that are relevant to 21 CFR Part 11—systems that manage operating procedures, that manage electronic batch records, and so on. Which are compliant today, and which are not compliant? Establish a plan of action, including a time frame, and a list of benefits and costs. And then execute the compliance plan, using a phased approach. How do you eat the elephant? One bite at a time.

The critical part is to look at [your company] as an entire entity. What you don't want to do is have a different system in regulatory affairs than you do in R&D. These people need to talk and communicate, because integrated systems are absolutely crucial in this area.

QUMAS provides enterprise compliance management solutions for the medical and other regulated industries. Its products aid manufacturers in complying with US FDA, EMEA, and international regulations. Validation, training, and installation are provided. The company is ISO 9001 certified and has offices worldwide.

Copyright ©2001 European Medical Device Manufacturer