Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical device and life sciences industries, is pleased to announce the release of their new med tech compliance solution.
Cognidox v10.1 contains a set of compliance tools designed to meet the requirements of FDA 21 CFR Part 11 and the MHRA GXP data integrity guidelines. This solution is in addition to the PDF digital signatures that Cognidox already supports.
v10.1 has been trialling since October and is now on general release for use by our life science clients.
See how Cognidox can help you be ready for FDA compliance
Cognidox v10.1 answers FDA CFR 21 Part 11 & GxP guidelines
Both the FDA and MHRA require a high standard of authentication around identity and intent for those using electronic signatures to approve medical device documentation.
v10.1 answers these specific requirements through the introduction of two new features.
1. e-Signatures, role and meaning on approval
This is an option for the system to force authentication during the approval of documents as required by FDA CFR 11.200a
- Credential checks: Before a signature can be added to a document you should be required to enter ”at least two distinct identification components”
- Repeated credential requests: If signings take place in separate sessions these identification components must be requested again.
v10.1 ensures a user name/password is requested on-screen or via an authenticator app on your mobile device for ‘single sign-on customers’ whenever relevant.
Cognidox also now ensures the ‘meaning’ of these actions are captured at the same time, in line with requirements in FDA CFR 11.200a
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
2. Signature manifestations
Cognidox have also added an approval manifest page to the PDF of the signed document which includes approver details (such as name, role, meaning of approval and time stamp) plus the version history.
This update meets both the FDA and MHRA requirements for the ‘meaning’ of every digital signing event to be appended to the document it relates to:
“Electronic signature or E-signature systems must provide for “signature manifestations” i.e. a display within the viewable record that defines who signed it, their title, and the date (and time, if significant) and the meaning of the signature (e.g. verified or approved).” Guidance on GxP data integrity, March 2018
In line with the regulation, these two new features are intended to enhance the transparency and trackability of the key decision making that governs the design and development of your medical device.
v10.1 is part of the development of Cognidox’s new MedDev eQMS product tier aimed at medical device developers and the life science community.
Customers can see how Cognidox’s eQMS software helps meet the documentation requirements within specific med tech regulation and other international standards at www.cognidox.com/compliance. These include:
ISO 13485, FDA 21 CFR PART 820, FDA 21 CFR Part 11 and the MHRA GXP data integrity
Cognidox is a leading provider of document management and web portal software for the med tech and high-tech product development sector. Founded in 2008 by Vittal Aithal and Paul Walsh it is based in Cambridge, UK.
It provides highly-integrated support for system engineering workflows and the product lifecycle. Plug-ins are provided for CMS products, software SCM tools, EDA tools, CRM systems, CAD tools and Help Desk applications. Cognidox’s "instant Extranet" solution enables companies to add a secure self-service customer portal onto their public web sites.
Cognidox started life as “Doxbox” – an in-house tool for fabless semiconductor company Virata. The goal was to make product development better by breaking down barriers between teams and making peer reviews much easier to do. Today, it has customers in over a dozen industry sectors, and its lean DMS supports its customer base in creating efficient, sustainable and compliant product development processes.