Compass Health Document Control SOP

Study Notes

This document outlines the process and responsibilities for controlling Compass Health documents. This includes creation, review, approval, and distribution.
The procedure applies to all controlled documents produced by Compass Health, including those related to the Quality Management System and product-related documents.
Key standards and regulations to be met include FDA QSR § 820.40 Document Controls, ISO 13485:2016 Section 4.2.4 Control of Documents.
Templates, forms and documents related to the Product Development Process are referenced.
The document includes a list of roles with responsibilities detailed.
- Authors: Prepare controlled documents and ensure adequate reviews and approvals are obtained.
- QA/RA: Administer the procedure and Document Management System, verifying compliance with the procedure, and ensuring retention and storage of all documents and records.
- Approvers: Review document content, accuracy, adequacy, and completeness, providing feedback to the author and authorizing/rejecting document release for use.
- Document Management System: Manages document versions, and electronic storage.

Controlled documents are managed through creation, approval, release, dissemination, retention, change, and expiry stages.
Each stage follows a detailed lifecycle process.
Document creation involves initiating the document, authoring it, reserving a unique document number, and entering it into the Document Management System (DMS). Templates are accessible to all employees within the DMS.
The document number is reserved from the DMS's Document Number Registry managed by QA/RA.
Documents are reviewed and approved by designated approvers, prior to release, following approver selection, draft circulation, approval and signing.
Document release and dissemination occurs upon the effective date, with documents becoming accessible for reading in the DMS. These are distributed according to a defined process.
Changes to documents require review and approval by either the original approving function or another designated function. Initially, the revised document is submitted to the DMS for approval, after which it may be used for training, if required.
Controlled documents, including revisions, are kept for a minimum of five years, or the product's lifespan.

Controlled documents are viewable, approved documents within the DMS.
Uncontrolled documents are issued to employees or external parties outside direct DMS access, for informational purposes only.
Obsolete documents are those rendered obsolete by content update or merging with another document.
External documents (non-Compass-created) are tracked and maintained.

Company documents are stored in the Document Management System (DMS).
This system is backed up according to pre-approved schedule and Supplier List.
Physical copies are stored in a locked cabinet, accessible only by QA/RA personnel. Physical copies are scanned and stored electronically to halt deterioration.