Data integrity according to 21 CFR part 11 rules

MEANING OF DATA INTEGRITY

If you have been in the pharmaceutical industry for some time, you may have realized that protecting data against accidental or intentional modification, distortion or deletion is the key to maintaining reliable health records that comply with established regulations. .

 

Data integrity refers to the act of keeping complete and intact data records in their original data context as they relate to other data records.

 

In this sense, you achieve data integrity when your data records are valid to offer the necessary services and comply with the regulatory framework that guides your organization.

 

DATA INTEGRITY ACCORDING TO 21 CFR PART 11 STANDARDS

One of the main advantages that computerized systems have over the pharmaceutical industry is that they allow us to maintain reliable and up-to-date electronic records that are easier to process, store and retrieve. Due to the advancement of information technology, managing health records has become very easy.

 

THE 21 CFR STANDARDS ARE A SET OF STANDARDS THAT GOVERN OR REGULATE THE MANAGEMENT AND USE OF ELECTRONIC RECORDS IN PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES.

The CFR 21 Part 11 is particularly concerned should apply regulate how electronic records as well as electronic signaturesin data management in the pharmaceutical industry. For this reason, data integrity under 21 CFR part 11 is related to the way these standards guide the management of electronic records, as well as electronic signatures. In this case, the goal of applying 21 CFR part 11 regulations to pharmaceuticals is to ensure that data records are reliable, complete and comprehensively maintained, hence why we are talking about data integrity. The 21 CFR part 11 regulations establish guidelines on the use and management of electronic records, as well as on electronic signatures. As a userelectronic data records, we must all be guided by 21 CFR part 11 rules so that we can all reap the benefits of data as well as act with complete integrity. In this case, the organization and the companies of the pharmaceutical industry are obliged, following 21 CFR part 11, to implement good commercial practices clarifying the methods under which electronic records, as well as signatures, are considered to be accurate, valid , reliable, confidential and in equal proportion to paper records and handwritten signatures.

 

The objective of the 21 CFR part 11 rule  is to promote the data integrity of the use of electronic records and signatures so that the data is not distorted, deleted or manipulated in any way that could compromise the provision of services. Therefore, it is requiredto pharmaceutical professionals who maintain a high degree of compliance with these standards to improve the reliability of electronic records, as well as signatures. In this way, the storage, processing, retrieval and dissemination of data / information become transparent and reliable for users. In addition, these standards ensure that the relationship between the data records is maintained. Maintaining the data relationship is important because it will allow you to retrieve information from various sources to improve decision making . In fact, 21 CFR standards improve data integrity by ensuring that the data held is reliable and equivalent. to the data of the records, signatures on paper.

 

§ 11.1 Scope.

 

(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

 

(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

 

(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.

 

(d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with § 11.2, unless paper records are specifically required.