Cygnet Infotech has launched its latest version of Cygnature – an electronic signing solution offering secure, legally valid e-signatures. The latest version includes a module designed for the pharma, biotech and medical equipment companies to help them in the FDA CFR Part 11 compliance.
The title 21 CFR [Code of Federal Regulations] PART 11 is a regulation act established by United States’ FDA [Food & Drug Administration] for electronic records and electronic signatures.
Cygnature – Key Features of CFR Compliance Module
- Allows access to authorized individuals only
- No Guest Access is allowed
- Ability to set up signer roles like author, reviewer, approver
- Time stamped Audit Trail
- Signer Authentication for each signature
- Completion certificate for each signing transaction which captures entire audit trail and digital footprint – IP, browser, device, timestamp
All these features ensure that the documents which are signed on the platform are secure, have been signed by the intended person and will be available for any audit.
Cygnature offers a wide range of signature types including electronic signature, digital, national ID sign, biometric, LIVE, photo sign and others. Every signature transaction captures the timestamp, IP address, Lat/ Long, device used, and browser used, in order to maintain absolute transparency in the documentation. Cygnature also allows businesses to integrate the software into their system with the use of API. With the use of custom bots, companies can seamlessly automate repetitive document uploading which saves a lot of time and prevents manual errors while focusing on core activities and scaling up quickly, on demand.
With Cygnature, users can sign documents from anywhere, anytime using any device quickly. Some of the strengths of the solution include providing highest security with encryption and blockchain. Further, it also tracks all the details of the signer like IP Address, Browser and Device details, Google Maps Location and Timestamp. There are ready API’s to integrate into business systems such as web portals, applications, or website, and Cygnature offers both on cloud and on premise model.
Commenting on the introduction of Cygnature’s latest version, Mr. Niraj Hutheesing, Founder & Managing Director, Cygnet Infotech said, “Cygnet Infotech established the product Cygnature with an aim to promote seamless digital signing of documents. We have launched the new version of Cygnature by incorporating a key feature CFR compliance, which will allow pharma companies based anywhere in the world to manage their GxP documents in a much more sophisticated manner in this digital age while eliminating errors.”