Data Integrity as per 21 CFR Rules : Pharmaceutical Guidelines

Data Integrity as per 21 CFR Rules

21 CFR has rules of data integrity its part 11 has every thing about electronic data and digital signature. Data integrity implementation improve the reliability of the documentation.

Meaning of Data Integrity

If you have been in the pharmaceutical industry for some time, you may have realized that protection of data from accidental/intentional modification, distortion, or deletion is the key to maintaining reliable health records which comply with the laid down regulations.

Data integrity relates to the act of maintaining complete and intact data records in their original context of data to the extent that they relate with other data records. In this sense, you attain data integrity when your data records are valid for offering the necessary services and comply with the regulatory framework guiding your organization.

Data Integrity as per 21 CFR Rules

One major benefit that computer systems have on the pharmaceutical industry is that they enable us to keep reliable and up-to-date electronic records which are easier to process, store, and retrieve. Due to the advancement of information technology, management of health records has become very easy. 21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals and medical devices.

Part 11 of 21 CFR rules is particularly concerned with regulating how electronic records, as well as electronic signatures in data management in the pharmaceutical industry, should be applied.

For this reason, the data integrity as per 21 CFR rules relates to how these rules guide the management of electronic records as well as electronic signatures. In this case, the aim of application of 21 CFR rules in data pharmaceuticals is to ensure that reliable and complete data records are kept in an integral manner.

21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures. As such, as the user of electronic data records, you are guided by 21 CFR rules so that you can have optimal benefits from the data and also act in integrity.

In this case, the organization and companies in pharmaceutical industries are required by Part 11 of 21 CFR rules to implement good business practices by clarifying the methods under which electronic records, as well as signatures, are taken to be accurate, valid, reliable, confidential, and in equal proportion to the paper records and signatures written by hands.
Related: ALCOA in Pharmaceuticals : A necessary tool for Quality

The aim of Part 11 of 21 CFR Rules is to promote the integrity of the usage of electronic records and signatures such that the data is not distorted, deleted, or manipulated in any way which would compromise the delivery of services. The pharmaceutical practitioners are, therefore, required to maintain a high degree of compliance with these rules to enhance reliability and trustworthiness of the electronic records as well as signatures. By doing this, the storage, processing, retrieval, and dissemination of data/information becomes transparent and reliable to the users.

Furthermore, these rules ensure that the relationship between data records is maintained. The maintenance of data relationship is important in that it will enable you to retrieve information from various sources for enhancing better decision-making. Indeed, 21 CFR Rules enhance the data integrity by ensuring that the data kept is reliable and equivalent to the data from the paper records/signature.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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