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As described in more detail below, the 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 record keeping 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)

We expect continued compliance with these provisions, and we will continue to enforce them. Furthermore, persons must comply with applicable predicate rules, and records that are required to be maintained or submitted must remain secure and reliable in accordance with the predicate rules.

B. Details of Approach - Scope of Part 11

1. Narrow Interpretation of Scope

We understand 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.

2. Definition of Part 11 Records

Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):

· Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records.

We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. We recommend that you document such decisions.

· Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities.

In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.

Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).

· Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format.

· Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).