As all the rest of your work has moved from manual to electronic, your Document Management System (DMS) should also be fully electronic. Preferably on the same platform you are using for the rest of your medical device development related work.
For example, if your software development team is using Jira, it is only natural that your organisation would like to have everything on Atlassian stack including your quality management documents.
Atlassian products are known for their full customizability, transparent pricing and fantastic integration features between Jira and Confluence where you can pull information easily from one to the other using built-in queries and macros.
A fully electronic Document Management System should comprise of:
a) Compliant Quality System documentation,
b) Electronic workflows for Document Review and Approval,
c) E-signatures to electronically approve the steps in the workflow.
TOP 3 FEATURES OF ELECTRONIC DOCUMENT MANAGEMENT SYSTEM:
Compliance to the major standards and regulations like ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR 820, and more. The system should be 21 CFR 11 compliant if you intend to enter the US market.
Quality Management System (QMS) is a collation of Procedures, documents, templates and records that describe and dictate how certain activities must be carried out for medical device products. This QMS must conform to certain requirements, most commonly ISO 13485 (EU, Canada, Australia) and 21 CFR 820 (USA).
Automation of the main processes, workflows, concurrent collaboration, traceability, easy linking, dedicated automation for processes like CAPAs, Changes, Training.
The principal advantage of an electronic DMS is to get rid of paper, but it is a basic expectation to have a high level of automation in the system. First and foremost for the workflows and electronic signatures.
Customization of most aspects of the system, such as permissions, workflows, content, security, settings, etc.
The less you depend on the developer to customize the system to your needs the better. As your company grows, you will have different requirements for your DMS. Locked templates, workflows, permissions, settings will force you to regularly need the services of the producers to make even the smallest changes.
You can learn more about how to turn Confluence into your electronic Document Management System with the MediCompli Solution.