The FDA does not usually approve, disapprove or review the services and products that let people be under the regulations of the FD. The 21 CFR part 11 compliance warehouse solutions is a rule that comes with evolving compliance that differs from distributors and manufacturers of the medical, cosmetic, and pharmaceutical devices.
It is the rule by the FDA for E-documentations and signatures. It helps companies outline the implementation of electronic records in managing the quality system in medical device companies.
It was 1997, when it was published initially, the electronic documentation and signatures turned advanced significantly. However, the goal of the 21 CFR part 11 is still applicable over 20 years later.
The reason why part 11 was designed was to fulfil the growing needs of the medical device industry to help companies. 21 CFR part 11 compliance warehouse solutions help in the following ways:
We have also had to be more practical when it is about managing companies' paperwork with more than one office or multiple needs for updating the records or accessing it. With the help of a system based on a paper in a single office can be challenging, and with offices based on the world, it will not be practical.
It is a daunting process for most companies to validate the 21 CFR part 11. However, it is essential to prove that the system is strong enough to comply with the standards.
The deployment and design method used by us offers the clients the capability to quality and get compliance with the FDA’s 21 CFR part 11. The base functionality targets the primary concerns in administering the computerized system with the help of electronic signatures and records. Controls in the warehouse come with user authentication, controls security, system access, and audit trails.
There are plenty of ways to 21 CFR part 11 compliance warehouse solutions. Let us discuss some of them:
Companies who do not want 21 CFR part 11 usually state that their master records are paper based. However, it may not be the case, and they upload the documents to a shared file or in some server that is accessible.
The FDA states in section 11.3 that any text combination, pictorial, data, audio, graphics, or any other information in the digital form which is maintained, created, modified, or distributed by the computer system is an electronic record.
Even if companies state that their records are based on paper, they may still have a pervasive electronic system. Companies still need to validate the records to ensure that the scanned version is the same as the paper version.
Clear audits are needed so that you can see which user did the given action. Companies should ensure that the events are recorded with the precise date, username, and time. We will assign a role to the user who will access audit trails for a reason.
Companies should know when someone logs in and out. It is referred to as the complete history of the record-keeping system.
Various software platforms are claiming to cater to all the needs of the 21 CFR part 11 compliance warehouse solutions.
However, it is not true as the responsibility will always be of the company. Know that the software company should not say that they have taken care of all of the needs as your company is responsible for that role.
Various platforms can help test, validate the platform, and support documentation; however, your responsibility will be compliances.
You should follow these tips to ensure that the integrity and security of the records and companies should be ready for the FDA inspection. Keep in mind that the medical device companies are responsible for compliance regardless of the promises of the third parties.