Eliminate Paper Records with Cockpit's Document Control System
21 CFR 820.40 instructs companies to establish and maintain procedures to control all documents required by Part 820 of the Quality System Regulations established by FDA.
a) Document Approval and Distribution
- Designate person(s) to review documents for adequacy and approve prior to issuance.
- Document approval includes date and signature of approving person(s).
b) Document Changes
- Have changes to documents reviewed and approved by same person(s) designated in part a.
- 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 Design History Files (DHFs) that can be used as supporting evidence for the Design Controls process as defined by 21 CFR 820.30.
Document Control Features
Comply with Cockpit
Cockpit provides built-in features for both formal and informal design reviews as well as Engineering Change Requests. Both of these mechanisms allow product teams to comply with 21 CFR 820.40 and 21 CFR Part 11 with ease.
Documentation is a significant piece of a device submission. A few primary goals of good documentation are:
- Demonstrating a compliant quality management system is in place throughout.
- Demonstrating your device has been developed and designed through the design controls process, ensuring the product is designed and validated based on the specific user needs.
- Demonstrating a solid risk management process throughout all stages of development and manufacturing.
It helps teams maintain all documentation relating to the product design. These documents are automatically generated by Cockpit based on information entered through the various exercises performed during device development. Once the design goes to market, Cockpit is capable of housing all postmarket details such as complaints and customer feedback, corrective and preventive action (CAPA), change orders, etc.