What’s 21 CFR Part 11?
In March 1997, the US Food and Drug Administration (FDA) issued regulations that established the criteria for accepting electronic and handwritten records and autographs executed on electronic documents. These rules also apply to pharmaceutical companies, biotechnology companies, natural product inventors and other diligence regulated by the FDA.
These laws are codified as Part 11 of Title 21 in the Law of Federal Regulations, or 21 CFR Part 11. It’s divided into three subparts
General Vittles
The General Vittles section discusses the compass of regulations, when and how they should be enforced, and defines some of the crucial terms used in the regulations.
electronic records
The Electronic Records section sets out the conditions for administering unrestricted and open electronic record keeping systems. It also discusses hand instantiations and the conditions for linking autographs to enrollments.
electronic autographs
Eventually, the Electronic Autographs section is divided into three corridor general conditions for electronic autographs, electronic hand factors and controls, and controls for identification canons/ watchwords.
It’s also necessary to remember that electronic autographs are authentications with ultramodern encryption systems. This ensures the identity of the person and the system has its trustability attested to in the document.
Since its original publication, 21 CFR Part 11 has generated a significant quantum of confusion among medical device manufacturers and other assiduity professionals who may use electronic records. The FDA issued a guidance document in August 2003 to clarify the compass and counteraccusations of colorful corridor of the regulations.
This document also served to further interpret the conditions for software confirmation, inspection trails, heritage systems operation, record keeping and record retention. Furnishing useful information about what companies need to do to misbehave with their 21 CFR Part 11 conditions.
With that said, it’s important to remember that these types of guidance documents aren’t the law. Medical device companies should always consult 21 CFR Part 11 directly when assessing their compliance status with FDA regulations.
Challenges to companies
System confirmation is about grueling and establishing a system and its entire terrain. This guarantees and evidences that it meets a set of defined conditions.
Likewise, healthcare companies must submit any system that impacts on Good Practices for confirmation. In this way, this ensures patient safety, in addition to the traceability and integrity of information, the quality of the product or process and any other nonsupervisory compliance issue.
For companies certified by Anvisa, there are specific legislations to gain the instrument in Good Practices, similar as Resolution of the Collegiate Board (RDC)16/2013 for Good Manufacturing Practices for Medical Products, or RDC301/2019, for Good Drug Manufacturing Practices. It’s these RDCs that propose the demand for confirmation of computer systems.
In addition, in April 2010 the National Health Surveillance Agency also published the Computerized Systems Validation Guide, which contains a description of the conditioning and liabilities for this confirmation. This companion is the main public reference for system confirmation. Still, there are still other important references that can be used, similar as the FDA 21 CFR Part 11.
The advantages of validating systems
Likewise, CFR 21 Part 11 provides an occasion for medical device companies to reap the organizational benefits of paperless record- keeping systems. Likewise, it also helps the FDA insure that when medical device companies use electronic record- keeping systems, document security and authenticity are duly maintained.
While some might argue that the 21 CFR Part 11 regulations put an fresh nonsupervisory burden on these companies, it’s important to note that significant benefits can be deduced from enforcing these electronic systems. As well, FDA guidelines help establish responsibility and traceability in all of your attestation processes, icing that
. Access to electronic records is limited to authorized individualities;
Account sharing between individualities, groups or departments isn’t allowed;
. Proper security protocols are followed to insure the integrity of watchwords and login credentials for all druggies;
Electronic autographs can not be transferred or copied between documents;
Electronic autographs are certified to match handwritten autographs and instrument is submitted to the FDA;
Records are tracked through document controls and an inspection trail that monitors changes and discerns invalid or changed records.
Medical device companies profit from espousing 21 CFR Part 11 regulations because it serves as a catalyst in guarding the integrity and confidentiality of their personal data.
Fresh benefits to medicine storehouse
In addition to nonsupervisory determinations, the system confirmation process brings fresh benefits to the health institution’s routine. Among these advancements are the bone that makes the platoon enjoying further in- depth specialized knowledge about the system used. This prevents it from being entirely in the hands of the supplier.
It also allows you to validate specialized discoveries, avoiding the loss of knowledge if professionals leave the company. And eventually, it facilitates the procedures for carrying out a comprehensive contingency plan. Therefore, in cases of breaks or crimes, it reduces product time-out.
Likewise, another benefit is related to medicine storehouse. From the moment that the temperature control and monitoring system has a confirmation regulated by the control bodies, its quality is guaranteed and it provides further safety to the case.
Still, similar confirmation of covering systems allows for lesser control and trustability in the process, in addition to guaranteeing all its traceability. This makes it easier to identify crimes in the process and correct them more snappily if necessary.
In short, using a systems confirmation system regulated by Anvisa and also following FDA CFR 21 Part 11 is necessary. Because it guarantees that your entire process follows the specified norms and will hardly present crimes.