FDA Part 11 – Electronic Records. Electronic Signatures....

Information & Training. | Medical Device Validation, Regulation, …

The US Food and Drug Administration (FDA) issued a regulation that provided criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. With this regulation, titled Rule 21 CFR Part 11, electronic records can be equivalent to paper records and handwritten signatures.

The rule impacts all FDA regulated industries that use computers for regulated activities.

Requirements of Part 11:

All computerized systems must be validated.

There needs to be secure retention of electronic records and instant retrieval.

User-independent computer-generated time-stamped audit trails.

System and data security, data integrity and confidentiality through limited authorized access to systems and records.

Use of secure electronic signatures for closed and open systems.

Use of digital signatures for open systems.

Use of operational checks.

Use of device checks.

Determination that the persons who develop, maintain or use electronic systems have the education, training and experience to perform their assigned task.


Electronic record.

“Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”


Electronic signature.

“An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.”

FDA Part 11 Electronic Records Electronic Signatures

Medical Device Validation, Classification, Regulation. Risk Evaluation. Etc. Information & training presentation >>>

Approach to Application of Part 11 by the FDA.

The FDA applies a “narrow interpretation of scope”

Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained or submitted to FDA, when an organization chooses to use records in electronic format in place of paper format, part 11 would apply.

Alternatively, when using computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable compliance requirements and persons (organizational staff, product users, …) 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”. In these instances, the use of computer systems in the generation of paper records would not trigger part 11.


Definition of Part 11 Records.

Under this narrow interpretation, FDA considers part 11 to be applicable to records or signatures in electronic format, where the …

… Records are required to be maintained in electronic format in place of paper format.

If however, Records are not required to be retained under compliance requirements, but they are nonetheless maintained in electronic format, they are not part 11 records.

The FDA recommends that you determine, whether specific records are part 11 records and that you document such decisions.


Electronic records and records that are required to be 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.

For example, if a record is required to be maintained 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 FDA may consider you to be using the electronic record instead of the paper record. That is, the FDA may take your business practices into account in determining whether part 11 applies.

Accordingly, the FDA recommends that for each record, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. The FDA recommends that you document this decision (e.g., in a Standard Operating Procedure (SOP), or other specification document.

Records submitted to FDA, 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 and it is maintained in electronic format.

Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signing. Part 11 signatures include electronic signatures that are used, for example to document the fact that certain events or actions occurred (e.g. approved, reviewed, and verified).

Information & Training.

Medical Device.

      • Validation. Classification. Regulation. Requirements. Current best practices.
      • FDA cGMP’s. EU MDR’s / MDD’s.
      • FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
      • FDA Medical Device Classification. The FDA approach to Medical Device Classification.
      • EU Medical Device Regulation and Classification (per MDD’s).
      • NewEuropean Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
      • Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
      • Quality System requirements to maintain compliant Validations.
      • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
      • Medical Device Software Validation.
      • Medical Device Design Validation.
      • Electronic Signature, Electronic Records.
      • Life Cycle Approach to Validation.
      • Risk Identification. Documentation. DHR’s. DMR’s.
      • Etc. Etc. …
      • Information & Training presentation >>>
FDA Part 11, Electronic Records; Electronic Signatures – Scope and Application