The cloud-based solution provides a pre-configured electronic Quality Management System with document approval workflows for the MedTech industry
Southampton, UK: 28th January 2020 – Clearvision, SoftComply and Comalatech today announced the release of MediCompli – their compliance solution for the Medical Device industry. Based on Atlassian Confluence, this medical device compliance solution includes a pre-configured Quality Management System together with out-of-the-box FDA 21 CFR 11 compliant document approval workflows and e-signatures, all of which fully customisable for additional workflows and compliance requirements.
MediCompli is the result of SoftComply’s industry expertise, Comalatech’s powerful approval workflows and Clearvision’s Atlassian and Cloud experience. Content-wise, users get a Quality Manual, a Quality Policy, 17 SOPs and 50 document templates that are based on ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR 820. All documents are pre-filled and have embedded guidance to fast-track the development and implementation of their compliant Quality System.
Dr. Marion Lepmets, SoftComply’s co-founder and CEO explains how MediCompli helps companies of all sizes comply with regulation – “With an increasing amount of software in medical devices and with software increasingly in the safety-critical role in these devices, an electronic compliance solution that is fully integrated into the toolset that software developers are already using – the Atlassian stack, is finally available. We are happy to offer MediCompli solution together with Comalatech & Clearvision that will help medical device companies automate their compliance management and get their medical devices on the market faster.”
The pre-defined approval workflows, fully auditable and traceable, are a key part of MediCompli’s Full Audit Trails capability. Comalatech’s CEO, Roberto Dominguez, is excited for the workflows to be available in a solution. “More and more organisations are using our Comala Document Management app to add reviews and approvals in compliance environments. One industry where proper management and control of documentation is crucial is medical device manufacturing. Partnering with Clearvision and SoftComply on MediCompli lets teams utilise approval workflows in a single, complete solution for document compliance.”
Hosting and supporting MediCompli in Clearvision’s AWS-powered cloud service was a natural decision for Gerry Tombs, CEO of the ISO27001 certified Atlassian partner: “Cloud is the way forward for most businesses, especially those that are built on continuous innovation and rapid growth – such as medical devices companies. We are delighted to join SoftComply and Comalatech in helping these fast-paced business focus on what they do best, and freeing them from time consuming compliance processes that are a source of distractions and often end up delaying go-to-market cycles.”
For additional information please visit www.clearvision-cm.com/medicompli/