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A major advantage of computer systems in the pharmaceutical industry is that they enable us to keep reliable and up-to-date electronic records that are easy to process, store and retrieve. Due to advances in information technology, health record management has become very easy. 21 CFR regulations are a set of regulations that regulate or control the management and use of electronic records in pharmaceuticals and medical devices.
21 CFR Part 11 compliance specifically deals with regulating how electronic signatures should be implemented in electronic records, as well as data management in the pharmaceutical industry.
For this reason, data protection and integrity as per the 21 CFR rules relate to how these rules govern the handling of electronic records as well as electronic signatures. In this case, the goal of applying the 21 CFR rule to data pharmaceuticals is to ensure that reliable and complete data records are kept in an integral manner.
21 CFR regulations set forth guidelines for the use and management of electronic records as well as electronic signatures. As such, as a user of electronic data records, you are governed by the 21 CFR rules so that you can get the most out of the data and act with integrity.
In this case, organizations and companies in the pharmaceutical industry must implement good business practices by Part 11 of the 21 CFR rules, which clarifies that electronic records, as well as signatures, are accepted as accurate, valid, reliable, confidential. , and in equal proportion to handwritten paper records and signatures.
Part 11 of the 21 CFR Regulations aims to promote the integrity of the use of electronic records and signatures so that data is not distorted, deleted or manipulated in any way that could compromise the delivery of services. Hence, pharmaceutical practitioners must maintain a high level of compliance with these regulations to enhance the reliability and trustworthiness of electronic records as well as signatures. By doing so, storage, processing, retrieval and dissemination of data/information becomes transparent and reliable to users.
Moreover, these rules ensure that relationships between data records are maintained. Maintenance of data relationships is important as it will enable you to retrieve information from different sources to make better decisions. In fact, the 21 CFR regulations enhance data integrity by ensuring that data retained is reliable and equivalent to data from paper records/signatures.
