This guidance is intended to describe the Food and Drug Administration’s( FDA’s) current thinking regarding the compass and operation of part 11 of Title 21 of the law of Federal Regulations; Electronic Records; Electronic Autographs( 21 CFR Part 11).2
This document provides guidance to persons who, in fulfillment of a demand in a enactment or another part of FDA’s regulations to maintain records 21 cfr part 11 applicability assessment or submit information to FDA3, have chosen to maintain the records or submit designated information electronically and, as a result, have come subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, recaptured, or transmitted under any records conditions set forth in Agency regulations.
Part 11 Also Applies To Electronic Records
Submitted to the Agency under the Federal Food, Drug, and Cosmetic Act( the Act) and the Public Health Service Act( the PHS Act), indeed if similar records aren’t specifically linked in Agency regulations(§11.1). The beginning conditions set forth in the Act, PHS Act, and FDA regulations( other than part 11) are appertained to in this guidance document as predicate rules.
As an outgrowth of its current good manufacturing practice( CGMP) action for mortal and beast medicines and biologics,4 FDA isre-examining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result of that reappraisal. This guidance explains that we will hardly interpret the compass of part 11. While the reappraisal of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 conditions.
That is, we don’t intend to take enforcement action to apply compliance with the confirmation, inspection trail, record retention, and record copying conditions of part 11 as explained in this guidance Electronic Records. still, records must still be maintained or submitted in agreement with the underpinning predicate rules, and the Agency can take nonsupervisory action for resistance with similar predicate rules.
In addition, we intend to exercise enforcement discretion and don’t intend to take( or recommend) action to apply any part 11 conditions with regard to systems that were functional before August 20, 1997, the effective date of part 11( generally known as heritage systems) under the circumstances described in sectionIII.C.3 of this guidance. Note that part 11 remains in effect and that this exercise of enforcement discretion applies only as linked in this guidance.
FDA’s guidance documents, including this guidance, don’t establish fairly enforceable liabilities. rather, guidances describe the Agency’s current thinking on a content and should be viewed only as recommendations, unless specific nonsupervisory or statutory conditions are cited. The use of the word should in Agency guidances means that commodity is suggested or recommended, but not needed.
In March of 1997, FDA issued final part 11 regulations that give criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic autographs, and handwritten autographs executed to electronic records as original to paper records and handwritten autographs executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to cover the public health.
After part 11 came effective in August 1997, significant conversations replaced among assiduity, contractors, and the Agency concerning the interpretation and perpetration of the regulations. FDA has( 1) spoken about part 11 at numerous conferences and met multitudinous times with an assiduity coalition and other interested parties in an trouble to hear further about implicit part 11 issues;( 2) published a compliance policy companion, CPG7153.17 Enforcement Policy 21 CFR Part 11; Electronic Records; Electronic Autographs; and( 3) published multitudinous draft guidance documents including the following
21 CFR Part 11; Electronic Records; Electronic Autographs, Validation
CFR Part 11; Electronic Records; Electronic Autographs, Glossary of Terms
CFR Part 11; Electronic Records; Electronic Autographs, Time prints
CFR Part 11; Electronic Records; Electronic Autographs, conservation of Electronic Records
CFR Part 11; Electronic Records; Electronic Autographs, Electronic clones of Electronic Records
Throughout all of these dispatches, enterprises have been raised that some interpretations of the part 11 conditions would( 1) unnecessarily circumscribe the use of electronic technology in a manner that’s inconsistent with FDA’s pronounced intent in issuing the rule,
( 2) significantly increase the costs of compliance to an extent that wasn’t contemplated at the time the rule was drafted, and( 3) discourage invention and technological advances without furnishing a significant public health benefit. These enterprises have been raised particularly in the areas of part 11 conditions for confirmation, inspection trails, record retention, record copying, and heritage systems.
As a result of these enterprises, we decided to review the part 11 documents and affiliated issues, particularly in light of the Agency’s CGMP action. In the Federal Register of February 4, 2003( 68 FR 5645), we blazoned the pullout of the draft guidance for assiduity, 21 CFR Part 11; Electronic Records; Electronic Autographs, Electronic clones of Electronic Records. We had decided we wanted to minimize assiduity time spent reviewing and opining on the draft guidance when that draft guidance may no longer represent our approach under the CGMP action.
also, in the Federal Register of February 25, 2003( 68 FR 8775), we blazoned the pullout of the part 11 draft guidance documents on confirmation, glossary of terms, time prints,5 conservation of electronic records, and CPG7153.17. We entered precious public commentary on these draft guidances, and we plan to use that information to help with unborn decision- making with respect to part 11. We don’t intend tore-issue these draft guidance documents or the CPG.
We’re nowre-examining part 11, and we anticipate initiating rulemaking to revise vittles of that regulation. To avoid gratuitous resource expenditures to misbehave with part 11 conditions, we’re issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain part 11 conditions during the reappraisal of part 11. As mentioned preliminarily, part 11 remains in effect during this reappraisal period.
Overall Approach to Part 11 Conditions As described in further detail below, the approach outlined in this guidance is grounded on three main rudiments Part 11 will be interpreted hardly; we’re now clarifying that smaller 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 conditions for confirmation, inspection trails, record retention, and record copying in the manner described in this guidance and with regard to all part 11 conditions for systems that were functional before the effective date of part 11( also known as heritage systems).We’ll apply all predicate rule conditions, including predicate rule record and recordkeeping conditions.
It’s important to note that FDA’s exercise of enforcement discretion as described in this guidance is limited to specified part 11 conditions( setting aside heritage systems, as to which the extent of enforcement discretion, under certain circumstances, will be more broad). We intend to apply all other vittles of part 11 including, but not limited to, certain controls for unrestricted systems in§11.10. For illustration, we intend to apply vittles related to the following controls and conditions
limiting system access to authorized individualities
use of functional 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 programs that hold individualities responsible for conduct initiated under their electronic autographs applicable controls over systems attestation
controls for open systems corresponding to controls for unrestricted systems bulleted above(§11.30)conditions related to electronic autographs(e.g.,§§11.50,11.70,11.100,11.200, and11.300)
We anticipate continued compliance with these vittles, and we will continue to apply them. likewise, persons must misbehave with applicable predicate rules, and records that are needed to be maintained or submitted must remain secure and dependable in agreement with the predicate rules.
Details of Approach- Scope of Part 11
Narrow Interpretation of compass
We understand that there’s some confusion about the compass of part 11. Some have understood the compass of part 11 to be veritably broad. We believe that some of those broad interpretations could lead to gratuitous controls and costs and could discourage invention and technological advances without furnishing added benefit to the public health. As a result, we want to clarify that the Agency intends to interpret the compass of part 11 hardly.
Under the narrow interpretation of the compass of part 11, with respect to records needed 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 induce paper printouts of electronic records, and those paper records meet all the conditions of the applicable predicate rules and persons calculate on the paper records to perform their regulated conditioning, FDA would generally not consider persons to be” using electronic records in lieu of paper records” under§§11.2( a) and11.2( b). In these cases, the use of computer systems in the generation of paper records would not spark part 11.
Description of Part 11 Records
Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or autographs in electronic format( part 11 records or autographs)
Records that are needed to be maintained under predicate rule conditions and that are maintained in electronic format in place of paper format. On the other hand, records( and any associated autographs) that aren’t needed to be retained under predicate rules, but that are nevertheless maintained in electronic format, aren’t part 11 records.
We recommend that you determine, grounded on the predicate rules, whether specific records are part 11 records. We recommend that you validate similar opinions. Records that are needed to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are reckoned on to perform regulated conditioning.
In some cases, factual business practices may mandate whether you’re using electronic records rather of paper records under§11.2( a). For illustration, if a record is needed to be maintained under a predicate rule and you use a computer to induce a paper printout of the electronic records, but you nevertheless calculate on the electronic record to perform regulated conditioning, the Agency may consider you to be using the electronic record rather of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.
Consequently, we recommend that, for each record needed to be maintained under predicate rules, you determine in advance whether you plan to calculate on the electronic record or paper record to perform regulated conditioning. We recommend that you validate this decision(e.g., in a Standard Operating Procedure( bribe), or specification document).
Records submitted to FDA, under predicate rules( indeed if similar records aren’t specifically linked in Agency regulations) in electronic format( assuming the records have been linked in program number 92S- 0251 as the types of cessions the Agency accepts in electronic format). still, a record that isn’t itself submitted, but is used in generating a submission, isn’t a part 11 record unless it’s else needed to be maintained under a predicate rule and it’s maintained in electronic format.
Electronic autographs that are intended to be the fellow of handwritten autographs, initials, and other general signings needed by predicate rules. Part 11 autographs include electronic autographs that are used, for illustration, to document the fact that certain events or conduct passed in agreement with the predicate rule(e.g. approved, reviewed, and vindicated).