Make Your Product Compliant to 21 CFR Part 11 Guidelines

1. Make Your Product Compliant to21 CFR Part11 Guidelines

2. In order to understand how we can make our product compliant with 21 CFR Part 11 Guidelines, first, we need to understand what 21 CFR Part 11 actually is, and in how many ways it is affectingour products. Firstly, to get a hold of 21 CFR Part 11 we need to understand its background and the purpose of its existence. It was officially published in 1996 and since then there have been numerous updates. 21 CFR Part 11 was developed with the idea to provide necessary rules and regulations on thematterof security concerns related to the issues ofdistribution, storage, and record-keeping by manufacturing firms, making drugs, biotech, and other medical equipment. Furthermore, these firms have been using paper for record-keeping which naturally results in substantialcosts. This regulationprovides the necessary standards and guidelines to help these firms to shiftfrom traditionalpaper-based record keeping to new and advanceddigitized systems.

3. Is it applied to yourfirm? If you are a manufacturer in the United States, who has any sort of data stored or uploaded onto any computer then consequently the 21 CFR Part 11 is applied to you and you have to make your product compliant withit. 21 CFR part 11compliance. To make sure your product is in compliance with 21 CFR part 11 you need to abide by the following requirements. There are mainly seven requirements that are most critical. 1.Validation. You need to validate your system (eQMS). Thisinvolves checking whether the system functions properly, is stable and all the data logs and records are safe and secure. After testing your systems and frequent checking, you need to do formal documentation, describing how your system works and claiming that everything worksfine.

4. 2. Recordgeneration. It is a requirement of 21 CFR part 11 compliance that your eQMS should support a smart search and indexing feature making sure finding data is easy and less time consuming for you as well as for anyauditor. AuditTrails. The eQMS you are using must create audit trails. The purpose of these audit trails should be storing the history of all the development that has been done. This history can be accessible but should not be editable ormodifiable. OperationalControls. Your firm’s eQMS should besophisticated enough forthe FDA auditor to understand the whole business process map. Based on this understanding the FDA inspector will audit and inspect thesystem.

5. 5. SecurityControls. The security of your eQMS should be impressive and strict. Each individual using the system must have his or her own password and without that password accessing the system must be impossible. All the records should only be editable by certain specified individuals, and every time a file is edited the system should create a record for that, which can be seen in thefuture. 6. DigitalSignatures. The use of e-signature has givensubstantial attentionin 21 CFR Part 11. Only those eQMS are compliant which have the ability to control the use of e-signatures. Controlling the use of e-signature involves, creating signature requests, canceling requests, and determining boundaries where the signature should apply. This will make sure the system is secured from any kind of fraud.

6. 7.Training. 21 CFR Part 11 urges firms to ensure complete training of all the individuals involved in operating eQMS. Trained professionals using eQMS will make fewer errors and the system will run smoothly. It is crucial for all the medical manufacturers willing to enter the US market, as it will ease the process of making the product compliant to 21 CFR Part 11 and improved the overall efficiency of the system by operating it to its fullpotential. Implementation of virtualization in the critical sectors likemedical manufacturing, naturally sets the bar of compliancesubstantially high. These guidelines are essential if you want your product to be compliant with the 21 CFR part 11. Following these will not just make the product eligible for the US market but also streamline system operations. Paperless documentation is quick, convenient, and harmless.