Med Associates Inc: Product Information

On September 3, 2003, the FDA issued the latest in their guidance on Part 11 compliance titled Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application (www.fda.gov/cber/guidance/5667fnl.htm). In the introduction section they state "As an outgrowth of its current good manufacturing practice (CGMP) initiative for human and animal drugs and biologics, FDA is re-examining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result of that re-examination. This guidance explains that we will narrowly interpret the scope of part 11. While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. That is, we do not intend to take enforcement action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of part 11 as explained in this guidance. However, records must still be maintained or submitted in accordance with the underlying predicate rules, and the Agency can take regulatory action for noncompliance with such predicate rules."

In the Federal Register of February 4, 2003, the FDA "announced the withdrawal of the draft guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records because we wanted to avoid loss of time spent by industry in an effort to review and comment on the draft guidance when the draft guidance may no longer be representative of FDA's approach under CGMP initiative. The other Part 11 draft guidances were left in place because industry had the opportunity to review and comment on them. However, in preparing this guidance, FDA has determined that it might cause confusion to leave standing the other Part 11 draft guidance documents on validation, glossary of terms, time stamps, maintenance of electronic records, and CPG 7153.17. Accordingly, FDA is withdrawing those draft guidances and CPG 7153.17 as well as the guidance on electronic copies of electronic records."

From the discussion section of the most recent guidance, the FDA's "approach outlined in this guidance is based on three main elements:

Part 11 will be interpreted narrowly; we are now clarifying that fewer records will be considered subject to part 11.
For those records that remain subject to part 11, we intend to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying in the manner described in this guidance and with regard to all part 11 requirements for systems that were operational before the effective date of part 11 (also known as legacy systems).
We will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.

It is important to note that FDA's exercise of enforcement discretion as described in this guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which the extent of enforcement discretion, under certain circumstances, will be more broad). We intend to enforce all other provisions of part 11 including, but not limited to, certain controls for closed systems in § 11.10. For example, we intend to enforce provisions related to the following controls and requirements:

limiting system access to authorized individuals
use of operational system checks
use of authority checks
use of device checks
determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
appropriate controls over systems documentation
controls for open systems corresponding to controls for closed systems bulleted above (§ 11.30)
requirements related to electronic signatures (e.g., §§ 11.50, 11.70, 11.100, 11.200, and 11.300)."

The FDA understands "that there is some confusion about the scope of part 11. Some have understood the scope of part 11 to be very broad. We believe that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health. As a result, we want to clarify that the Agency intends to interpret the scope of part 11 narrowly

Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be "using electronic records in lieu of paper records" under §§ 11.2(a) and 11.2(b). In these instances, the use of computer systems in the generation of paper records would not trigger part 11."

In light of FDA's stated intent of narrowing the application of Part 11 requirements and the withdrawal of definitive guidance while Part 11 is re-examined, it is Med Associates position that our test and data collection software does not require additional modification or updating to comply with Part 11 requirements until the re-examination is complete and further guidance is issued. The requirements for hardware and system level control, written operating procedures, and electronic signatures, which the FDA is enforcing, are beyond the scope of Med Associates' software. However, if you need assistance in these areas, we have surveyed the industry and have compiled a list of potential vendors who provide these services. Our sales staff can provide this list upon request.