January 25, 2016

What is 21 CFR Part 11?

These days, manufacturers are talking about the FDA’s 21 CFR Part 11 requirements for electronic documentation but what does that mean? This primer will give you an understanding of the FDA’s requirements.

In the 21 CFR Part 11 documentation, the FDA states:

“FDA has concluded that regulations are necessary to establish uniform, enforceable, baseline standards for accepting electronic signatures and records.”

Part 11 regulations cover issues such as:
•Security
•Audit trails
•Electronic signatures
•Copies for inspection

The Software Development Life Cycle steps and the Computer Validation steps that were used in developing InstantGMP™ MES, InstantGMP™ VAPE, InstantGMP™ MD and InstantGMP™ PRO assure compliance with 21 CRF part 11 requirements for closed systems.

All InstantGMP™ systems comply with the 21 CFR Part 11 regulations shown below:

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

(d) Limiting system access to authorized individuals.

(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

(k) Use of appropriate controls over systems documentation including:

(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.