The 21 CFR Part 11 and EU GMP regulations both require organizations to have in place three levels of control:
- Administrative controls: policies for these regulations and the use of electronic signatures
- Procedural controls: SOPs for using the system
- Technical controls: functions built into software that ensure the reliability and integrity of electronic records and signatures
This means that it is not possible for any supplier to offer a turnkey compliant system. There is software that can be designed to be compliant with the technical controls of the regulations, but it is the user who is responsible for providing policies and procedures to ensure the systems are fully compliant with the regulations and the predicate rule applicable.
STARe Software has a 21 CFR Part 11 software option that is specific for those working under the regulation. We have compiled a list of frequently asked questions (FAQs) that will help you understand how the METTLER TOLEDO STARe software handles the technical controls required of 21 CRF Part 11.
Key features
The STARe software has been designed to work as a closed system. Its key features are:
- Access Control to the application (password)
- User Level Management (user rights)
- Electronic Records (file integrity)
- Audit Trail (change and system history)
- Electronic Signatures (status of electronic records)
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21 CFR Part 11 requires three types of controls:
- Administrative controls, e.g. policies such as identification of individuals and non-repudiation of electronic signatures
- Procedural controls, e.g. Standard Operating Procedures for using and maintaining a system
- Technical controls, e.g. security and access to the application and audit trail
Published in March 1997 and effective on August 20, 1997, the Electronic Records; Electronic Signature final rule (21 CFR Part 11) has had a greater impact on computerized systems than any other regulation. The basic requirement forces computerized systems to ensure the integrity, reliability, and trustworthiness of electronic records. In addition, electronic signatures must be trustworthy and equivalent to handwritten signatures executed on paper records.
21 CFR Part 11 Definitions
Electronic records
Electronic record means 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
Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.
Closed system
Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
