Cygnature’s 21 CFR – How to stay compliant with 21 CFR part 11 regulation?

  • May 24, 2022
  • Reading Time: 3 minutes
Reading Time: 3 minutes

21 CFR Part 11 is a federal law that requires companies to follow certain procedures when dealing with sensitive patient information. The regulations apply to healthcare providers, health plans, hospitals, pharmacies, medical device manufacturers, and other entities that handle or store protected health information (PHI). 

Cygnet Infotech has been a leading IT solution provider for more than two decades now. Cygnature, the e-signing solution with Blockchain technology by Cygnet Infotech, is a comprehensive solution that helps organizations with 21 CFR compliance. This module provides a secure environment to help maintain electronic records of approvals and documentation like sampling, trials, etc.   

The module includes: 

  • Electronic Signatures 
  • Review and Approval Workflows 
  • Data Protection 
  • Audit Trail 
  • Secure Messaging 
  • Document Management 
  • Advanced Encryption 

This module offers complete 21 CFR compliance, including encryption, audit trails, data retention, access control, and other features. It also supports the storage of multiple types of electronic records, such as text documents, images, PDFs, XLSX files, etc.

What is Cygnature?  

Cygnature is an award-winning solution that securely authenticates signers and offers them a variety of signature types for signing. This seamlessly developed tool also ensures to protect the signed documents from tampering.  

It is designed with cutting-edge technologies, offers choice of signature as well as top notch security. The security of Cygnature is seamless because the audit trail is done on Blockchain, and it offers advanced encryption. 

Cygnature’s CFR Module helps Pharma companies and Medical Equipment Manufacturers to stay compliant with the FDA’s 21 CFR Part 11, EU Annex 11, and GAMP-5 guidelines.  

  • Securely sign GxP documents such as sampling records, test results, calibration records, quality documentation, and SOPs 
  • Authenticate the signers while applying signatures 
  • Use Active Directory for authentication 
  • Select signer role as creator, reviewer, or approver 
  • Maintain a timestamped audit trail 
  • Configure signing reasons 

Key Features of the CFR 

  • Provide access to authorized individuals only (no guest access) as per 21 CFR 11.10 (d) 
  • Record a computer-generated time-stamped audit trail as per 21 CFR 11.10 (e)  
  • Signature appearance with name of signer, date, and time of signing and the reason for signing as per 21 CFR 11.50 
  • Authenticate the signer while applying for the signatures as per 21 CFR 11.200 
  • Use access code in combination with password as per 21 CFR 11.300 

Why is Cygnature’s CFR Module Recommended? 

Precise Validation 

Cygnature offers validation of the system to make sure that it is accurate, reliable, and brings consistency. The entire validation process is aimed at reassuring the security of data and audit logs.  

Generation of Records made Easier 

Based on the Part 11 mandate, your eQMS shall consist of indexing and a search feature that lets you search for records quickly and without any hassle. 

Secured Audit Trails  

As it is based on Blockchain technology, auditing is something you would not even need to worry about. It is a technology that offers secure, time-stamped audit trails that record date, time, location of the entries and actions on the document. It offers a clear view of the records consisting of the trails of documents being modified. The audit trails are developed automatically and are not even modifiable. 

Smart Security Controls 

Cygnature by Cygnet is highly secure, and it does not let any unauthorized person make any alteration in the document.  

Wrapping Up 

Get this fully featured module and be CFR compliant with all the innovative features of the 21 CFR part 11 electronic signature module. Cygnature’s CFR Module offers a comprehensive digital signing feature to help digitize all the compliance requirements. Book a demo with us and learn more about Cygnature and its multi-functional features.  

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