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21 CFR Part 11, the guide for the industry

The evolution of production and management systems leads to the progressive dematerialization of the records necessary to prove the conformity of industrial productions: material batches used, equipment used, quality controls carried out, labeling tests carried out,…

21 CFR Part 11 et l'industrie pharmaceutique

The digitalization of the industry

Today, production equipment issues operating reports or alarms in electronic form, operators make computer entries, scan material barcodes.
The initial information is no longer only handwritten on a paper document as it was 20 years ago, but also electronically recorded.

This evolution has raised 2 essential questions in highly regulated industries like the pharmaceutical industry:

  • How can we ensure that records are reliable, i.e. durable and tamper-proof ?
  • How to establish secure signatures for records and approvals ?

US Regulations: 21 CFR Part 11 Definition and Specifications

To cope with this development, the U.S. Department of Health and Human Services created the FDA (Food and Drug Administration), which established a standard in 1997, 21 CFR Part 11.

Logo de la Food and Drug Administration pour la norme 21 CFR Part 11

The 21 CFR Part 11 standard defines the rules to be respected during the development of computer systems in industry to meet the challenges of traceability of records and electronic signatures.

The FDA 21 CFR Part 11 standard is composed of 2 main sections :

  • All controls and procedures related to electronic records such as data backups, data security and computer system validation.
  • Features that ensure system security, data audit trails and electronic signature integrity.

21 CFR Part 11: for whom and why ?

21 CFR Part 11 regulations: for which industries ?

All companies in the pharmaceutical, cosmetic and food industries must meet the requirements of 21 CFR Part 11 in order to market their products in the United States.

What is the FDA’s goal with 21 CFR Part 11 ?

The Food and Drug Administration (FDA) requires the implementation of Good Manufacturing Practices (GMP) to ensure that products manufactured by industry meet its quality requirements.
In this way, the FDA hopes to prevent the release of finished products that do not comply with the company’s validated quality policy, for example to avoid a food scandal.

Risks for non-FDA 21 CFR Part 11 compliant applications

Any application (computer or paper) can potentially be checked by an FDA auditor. Non-compliance with certain points of the standard can lead to fines or a complete shutdown of production in the event of product non-compliance. At this point, it is clear that the investment in an IT solution is quickly paid off when simulating a production stoppage or the salary costs of preparing for a quality audit.

21 CFR Part 11 Implementation Process for an Industry

Objectives :

The project to comply with the 21 CFR Part 11 standard goes hand in hand with the implementation of MES software. We are therefore trying to meet the objectives of continuous improvement:

  • Eliminate paper in the workshops to reduce (re)entry errors: this is a process of dematerialization and document management (EDM = Electronic Document Management).
  • to have an ascending and descending computerized traceability to save time when searching for a batch, a component: from digitization to archiving with the use of metadata. This is called “records management”.
  • computerize the manufacturing file and document flow management (or electronic batch record, “Master Batch Records”) to facilitate batch release
  • Save time on problem escalation to reduce non-conformities through automation and document indexing.

Start your industrial application 21 CFR Part 11

Any project requiring FDA validation must be organized in a precise manner. This starts with the writing of documents containing the “User, Functionality and Architecture Specifications”. The IT team in charge of designing the industrial application will use these documents. In parallel to these different steps, the qualification documents, called IQ (Installation Qualification), OQ (Operations Qualification) and PQ (Performance Qualification) must be written. These documents will be guides for the validation of the application.

Specific application or market standard ?

The availability of the 21 CFR Part 11 standard allows MES software vendors to offer standardized solutions to facilitate the integration of an FDA 21 CFR Part 11 compliant industrial application.

Rather than starting from scratch, manufacturers can choose a solution that has already been validated by FDA 21 CFR Part 11. Capitalizing on these projects allows manufacturers to make economies of scale compared to a specific development.
It is even possible to measure a quick return on investment when comparing the cost of acquiring such software with the costs generated by the recall of an entire batch, the production stoppage, the fine in case of FDA 21 CFR Part 11 non-compliance.

Validation of the application according to 21 CFR Part 11

Once all the preparations are completed (specifications file, IQ, OQ, PQ documents, etc.), the application can enter the validation phase. This one is carried out :

  • or by an internal department of the company (often the quality department)
  • or by a third party specialized in this activity

The validation of the application according to 21 CFR Part 11 consists of a series of tests and verifications to check the compliance of the application with the requirements of 21 CFR Part 11. At the end, the validation team will issue a positive or negative opinion, with or without corrective action.

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