FDA 21 CFR part 11 (also merely referred to as part 11 in common instances) designates that electronic records and signatures are as valid as paper records and written signatures. Once the regulation was enacted in 1997, it had been commended as a landmark rule. At long last, the utilization of electronic record-keeping systems is permissible in compliance with the initially established restrictive needs that applied to paper-based systems, conjointly called U.S. Food and Drug Administration (FDA) predicate rules.
In recent times, the FDA has resorted to tight social control actions, issuing warning letters to many high world corporations. This means the bureau plans to conduct additional inspections with larger detail and accuracy and has heightened its oversight. While this is often a welcome move for strengthening patient health and safety and charitable trust within the system, it concerns corporations to be additional alert and take all doable preventive actions to avoid FDA warning letters.
What is a predicate rule?
A predicate rule is any office regulation that needs a corporation to keep up bound records and submit specific data to the agency as a part of compliance. Though predicate rules originally applied to paper records with written signatures, thanks to part 11 they’re additionally applicable to electronic records and signatures used for compliance functions. Part 11 does not seem to be determined to interchange or disregard alternative existing office laws touching on signatures and records. They’re merely a contemporary extension of the necessities for records and signatures that must be met by corporations that use digital systems to manage compliance-related processes and activities.
What is the role of 21 CFR part 11?
The mandate for the government agency is to shield public health. Its primary goal is to confirm that merchandise within the US market doesn’t seem to be corrupted or mislabeled. FDA, as a part of its inspections, verifies compliance to Current Good Manufacturing Practices (cGMPs) and quality system regulations, monitors removals of stock, devices, and medicines inside the US, adverse events, as well as death and heavy injuries. It authorizes stock purchasable within the U.S., through analysis and approval processes, and conjointly evaluates and clears foreign commodities for safety and usage.
The various methods to avoid 21 CFR part 11 citation:
- Determine company policy: Companies unwilling to embrace FDA 21 CFR part 11 usually say their “master records” are paper-based, though they are transferring documents to a shared file or some accessible place on a server. They suppose that “paper-based” records mean no effect on part 11, however, this cannot be the case. “Master records” could be a misuse of the term. People can say that the piece of paper is their “master record” and suppose that what they are doing subsequently (such as scanning and uploading) doesn’t matter if the paper remains intact. The reality is, the moment the document is uploaded to a server, the company is subject to compliance with 21 CFR part 11 compliance.
- Password policy: When it involves digital security, passwords are a significant part. Security is that the biggest space of concern with 21 CFR part 11 validation as a result you need to recognize that proper individuals have the proper permissions. Access to electronic records ought to be controlled by a unique login, with a username and password. Users inactive for 10-20 minutes ought to be logged out automatically. If the account has been inactive for an amount of time, the user should be logged out.
- Audit and Control: Clear audit tracks are needed to be able to read which user performed any given action and at what time. All events must be recorded with the precise username, date, and time. Besides, to vary management, audit trails apply to moments of access. You must keep a note of when a user logs in and logs out. One can determine a complete history of your record-keeping system.
- Preventive action measures: While preventive actions modify firms to avoid potentially troublesome situations, appropriate corrective actions help in avoiding warning letters and alternative social control actions and facilitate them to build a healthy relationship with the agency. The effectiveness of action should be verified, and proof of action maintained, through correct documentation. Effective coaching metrics aligned with established procedures are necessary to confirm the supply of qualified specialists. Result-oriented coaching programs need systematic designing, execution, and analysis.
Complying with 21 CFR part 11 does not mean to be an exhausting task, notably if you aim in mind that any plan of a “paper-based master record” could be a complete name when something is uploaded to a computing system. In different words, virtually each Life Science company should comply with 21 CFR part 11 unless they do have everything on paper solely, with no electronic copies of documents deposited in a particular place.