Eliminate paper records with Cockpit’s Document Control Systems

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.

  • 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 a Design History File (DHF) that can be used as supporting evidence for the Design Controls process as defined by 21 CFR 820.30.

  • designanddevplanning

How Cockpit Complies

The Cockpit Platform provides built-in features for both formal and informal 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 the entire design process.
  • Demonstrating your device has been developed and designed through the design controls process, ensuring the product is designed and validated based on the specified user needs.
  • Demonstrating a solid risk management process throughout all stages of development and manufacturing.

The Cockpit Platform 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, change orders, etc.

Document Control Features

Cockpit has an extensive team review feature built into Cockpit. This built-in feature allows for both formal and informal reviews of all documents within a given project. All reviews are controlled by Cockpit’s comprehensive workflow feature. Unique electronic signatures for every approval in a review cycle are 21 CFR Part 11 compliant.

review_feature

The Cockpit Platform has a built-in mechanism for completing Engineering Change Requests (ECR). Controlled by workflow, change requests are added to the ECR for later approval. The person selected to be the approver has the ability to accept or reject changes with ease, making this part of the process seamless.

change_request

With single-click exports to PDF, Word, XML, Excel, and Powerpoint, documents can be taken from Cockpit and stored in the official system of record for the organization. Alternatively, Cockpit can be used as that system of record for keeping all documentation and relating reviews/approvals in one place.

one_click_export

 

The Cockpit Platform comes with full auditing capabilities so you know what was changed, who made it, and when it occurred. Everything in the system is audited, from permission changes to configuration additions. Auditing is controlled based on the workflow phase, only tracking changes when necessary. Audit logs can be easily exported in case of audit.

audit_log


SUBMISSION-READY ARTIFACTS

PDF submission-ready artifacts
at the click of a button.

OPEN API

Connect other programs to Cockpit to transfer data between the two. The possibilities are endless.

REQUIREMENTS MANAGEMENT

Manage all aspects of requirements for your
project in Cockpit.

AUDIT TRAIL

See what changed, by whom, and when with Cockpit’s full auditing options.

RISK MANAGEMENT

Manage all risk-related activities in Cockpit. Custom scoring and color settings are available.

ALLOCATION MATRICES

Easily allocate design inputs, user needs, etc. to sub-systems of the design.