Anyone who has been in the medical device industry, or is trying to venture into that industry should know about the FDA 21 CFR part 11. The CFR part 11 involves a lot of technicalities, and it is easy to get intimidated by the slew of schedules and initials which may come across while trying to venture into this robust industry. However, with the right mentality, it can be relatively easy. Here is a guide to help anyone understand what the CFR part 11 means.
What Exactly Is CFR Part 11?
Put in simpler terms; this is Part 11 of Title 21 of the Code of Federal Regulations. To explain a bit further, this section sets out how a company operating in the United States can use electronic quality records and digital signatures instead of paper-based documentation and ‘wet signatures’ in such a way that complies with FDA regulations.
The Background of Part 11
1996 was the year it was first published, and since then, there have been various iterations that were introduced to keep up with the changes in technology. The fundamental reason for its existence was as a response to security concerns about how to manage the distribution, storage, and retrieval of records by manufacturers of biotechnology, drug, and medical equipment in the digital age. Another reason was to address the enormous costs that these companies incurred while maintaining paper-based filing systems just to satisfy the regulator. Generally, the key objective was to allow these firms to shift to virtualized networks.
What Are the Main Requirements?
For proper compliance to CFR part 11, a few requirements are necessary. Here are the seven critical requirements of 21 CFR part 11.
Part 11 requires validation of systems to ensure accuracy, reliability, and consistent intended performance. One should formally define how all the elements that are part of the system are designed to work. They should then come up with test routines and scripts to validate that it is working as it should. Validation also serves as reassurance on the security of one’s data and audit logs, as well as increasing the integrity of record keeping.
One’s eQMS must have indexing and search functionality to make it easy for the owner or an inspector to find records easily. A good proprietary eQMS will have just this kind of search function with search results showing all document changes and iterations, indicating what a ‘final version is’, as well as displaying the digital signatures of any approval they were subject to.
Part 11 stipulates that one should use secure, computer-generated, time-stamped trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. A good system will ensure that any developments made on all of one’s processes are well documented and can be traced to a particular originator and have an associated audit history. The audit history should not be modifiable and should be automatically generated.
Another requirement is that the eQMS should allow for quality procedures to be monitored and controlled through a process commonly known as ‘phase gating.’ This will make sure that the documents are reviewed by specified individuals and that they meet the prerequisites before they are signed off, and a contingent phase begins.
It goes without saying that a unique login and password should control entry to every system. This is to prevent any unauthorized access. The system should be able to specify the number of people who can make changes to particular documents as well as track each version of the file. It is important to note that final records should be read-only.
Part 11 has clearly mapped out the requirements for the use of a digital signature. It insists that there should be a recognized Certification Authority to act as a notary to verify a signer’s identity. The exact words used by FDA CFR part 11 are “A digital signature is an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.”
The FDA allows for the use of digital signatures in place of wet signatures on paper in order to streamline and virtualize business activities. However, for them to be compliant, they should include the printed name of the signer, the date/time when the signature was applied, and the ‘meaning’ or intention of the electronic signature.
A good system will give the administrator total visibility and control over the use of these signatures across their systems. They should have the ability to create and cancel signature requests and also set the locations where signatures can be used to protect against fraud.
The final requirement is for all users to have undergone the necessary training to perform their assigned projects. An eQMS can itself aid with this requirement by accepting conditions upon signing into the system or procedurally by detailing this responsibility as part of the training.
For any medical developer looking to enter the competitive US market, compliance to the CFR part 11 is necessary. This process can be made a little easier by finding an eQMS that is specially developed to combat those regulatory challenges.
What Computer Systems Must Be Compliant With 21 CFR 11?
It is imperative that each and every computer that will be used to store data that is necessary when making quality decisions or data that will be reported to the FDA be compliant with 21 CFR 11. For situations that involve laboratories, any laboratory results used to determine quality, safety, strength, efficacy, or purity should also be included. As for clinical environments, what is included are all data to be reported as part of the clinical trial used to determine quality, safety, or efficacy, and lastly, for the manufacturing environment, all decisions related to product release and product quality.
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