Activity

  • This is a little out of my scope of my job, but I was just at conference and the large device companies use different systems. For example Cognition has a platform called Cockpit, which a risk management and design control platform for medical device, and pharma development teams.

    21 CFR 820.40 instructs companies to establish and maintain procedures to control all documents required by Part 820 of the Quality System Regulation established by FDA. For Document Approval and Distribution, you designate one or more people to review documents for adequacy and approve prior to issuance.Document approval includes date and signature of approving person(s). Document Changes-have changes to documents reviewed and approved by same person(s) designated in part Communicate changes to the appropriate personnel in a timely manner. The Cockpit Platform provides a single, backed-up repository for creating Design and Development Plans along with Risk Management Plans. The platform also auto-populates a Design History File (DHF) that can be used as supporting evidence for the Design Controls process as defined by 21 CFR 820.30. I think using electronic systems like this one are great so you can see who is working on the documents so if something changes you can see exactly who made a change and go to them to discuss.

    Document Controls