Compass Health AI SOP: Document Control PDF

Compass Health AI SOP: Document Control Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin...

Compass Health AI SOP: Document Control Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document#: QMS-SOP-0002 Revision History Version Date Description 1.0 03 Jan Initial Release 2024 Document#: QMS-SOP-0002 1 Introduction This document outlines the process and responsibilities for control of documents at Compass Health, including the creation, review, approval and distribution of documents. 1.1 Scope This procedure applies to all controlled documents prepared by Compass Health including those specific to the Quality Management System and product-related. The process for handling changes to documents is also described within this SOP. 2. Applicable Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.40 Document Controls ISO 13485:2016 Section 4.2.4 Control of Documents 2.2 Reference Documents The following documents, templates and forms are referenced within this procedure and are related to the Product Development Process: Document Title Document Number SOP: Control of Records QMS-SOP-0003 Document#: QMS-SOP-0002  SOP: Product Development Process QMS-SOP-0007 3 Acronyms and Definitions Table 1: Acronyms Acronym Meaning Document Management DMS System QMS Quality Management System QA Quality Assurance RMT Risk Management Team Table 2: Definitions Term Meaning Controlled The currently viewable, approved documents within the DMS documents Documents issued to employees and/or outside parties by means Uncontrolled other than direct access from the DMS and shall be used for documents information only, by individuals who are not affected by the document. Document#: QMS-SOP-0002  Obsolete Documents, in which the content has been rendered obsolete, or by documents merger of contents with another document. 4 Process Roles Role Description of Responsibilities Preparation of controlled documents and for ensuring that Author adequate reviews and approvals are obtained QA-RA Administration of this procedure and of the Document Management System Verifying compliance to this procedure Retention and storage of all documents and records Are also reviewers as they are responsible for reviewing the content of a document assigned to them for accuracy, Approvers adequacy, and completeness and for providing feedback to the author Authorizing or rejecting the release of the document for use Document An electronic storage system used to manage the versions Management of documents and records created at Compass Health System 5 Document Control Process Controlled documents are managed throughout their lifecycle by a rigorous process of creation, approval, release and dissemination, retention, change, and expiry. At a high level, a document will follow the lifecycle process shown in Figure 1. Document#: QMS-SOP-0002 Figure 1: Controlled Document Lifecycle Process Each of these stages are detailed in the sections below. 5.1 Document Creation Authors are responsible for initiating creation of new controlled documents. The document creation process includes creating and authoring the document itself, generally from a template, reservation of a unique document number, and entry into the Document Management System (DMS). Templates are stored within the Document Management System, accessible to all employees. The Author shall reserve a document number from the Document Number Registry, which is in the DMS and is managed by QA-RA. The Document Number Registry will automatically assign a document number at the time of reservation. Controlled document creation follows the process shown in Figure 2. *Note: it is acceptable for the document number reservation step to occur prior to initiation of the draft. Figure 2: Controlled Document Creation Document#: QMS-SOP-0002 All controlled documents are subject to review and approval prior to being made available for retraining. The review and approval process includes approver selection, draft circulation, approval, and signing. This follows the process shown in Figure 3. Figure 3: Controlled Document Review and Approval At a minimum, the list of approvers shall include persons from the groups identified in the Approval Matrix (Appendix A). The approval matrix may be superseded by the Product Development Plan (i.e. reviewers and approvers can be assigned in the project plan for specific project related documents). The selection of specific approvers is performed by the author, and may include additional personnel as deemed appropriate. Documents are approved by the author explicitly, prior to circulation for approval by others. Drafts may be circulated at any time prior, to solicit comments and suggestions, and to build consensus. Documents shall initially be only submitted into the Document Approval space within the Document Management System to allow for collaboration and approval prior to dissemination of the document. The Document Approval space shall only be accessible to reviewers and approvers as specified in Appendix A: Approval Matrix, to prevent the unintended use of such documents prior to its effective date. Once a document has been approved by all approvers, the document shall be used for training, if training is deemed required by QA-RA or Functional Managers. At least one approver shall be responsible to review the document specifically for document construction and identification, including: table of contents and any captions that have been updated Document#: QMS-SOP-0002  document number is correct and has been updated to reflect the new revision and remove draft status author and correct approvers are identified on the cover page, and match those in any approval workflow interface If training on the document is required, affected individuals shall be notified via email or any alternative means of communication. Training may involve self-training or a group training session. All training records shall be maintained as quality records, per SOP: Control of Records. 5.3 Document Release and Dissemination On the effective date of the controlled document, the document shall be released and made available for read-only viewing within the Document Management System and disseminated according to the process in Figure 4. Only current versions of controlled documents may be used to perform operations that affect product quality. Figure 4: Controlled Document Release and Dissemination The QA-RA makes documents available to all employees on the effective date of the approved controlled document. Dissemination is performed through notification by email or other channel in writing, indicating the availability within the DMS. This marks the completion of the release phase. Document#: QMS-SOP-0002 5.4 Document Change Changes to controlled documents shall be reviewed and approved either by the original approving function or another designated function that has access to pertinent background information upon which to base its decisions. The revised document shall initially be submitted for approval in the Document Approval space within the Document Management System. Once the revised document is approved by all required approvers, the revised document shall be made available for retraining purpose only, if required. If training is required as a result of the change(s) made, affected individuals shall be retrained on the document prior to the document’s effective date. Training may involve self-training or a group training session. Records of retraining shall be maintained as quality records. If training is not required, all changes made to the previous version of the “changed document’ shall be notified through email or other channel in writing, clearly outlining the changes made to the previous version of that document. The revised document shall be released and disseminated to the team within the Document Management System on its effective date. 5.5 Document Retention and Expiry Controlled documents, including all revisions, shall be retained for no less than five (5) years or for at least the lifetime of any medical device – the longer of the two would apply. Nominally, all controlled documents, and associated approved revisions, will be retained permanently within the DMS. Documents may be obsoleted, either by the content being rendered obsolete, or by merger of contents with another document. To obsolete a document, a change should be enacted to revise the document such that it contains document preamble only, indicating in the change history the obsolescence of the last revision. To merge a document, the new merged document should first be created and approved. Promptly thereafter, the now-obsolete document should be revised to contain document preamble only, indicating in the change history the new document number under which the merged contents exists. Document#: QMS-SOP-0002 Specific to Health Canada’s Summary report: Copies of your summary reports and the information used to prepare the reports must be kept 7 years. 5.6 Deterioration and Loss of Documents Company-controlled documents and quality records are stored in the Document Management System (DMS). Quality records may also be stored on other platforms (for ex. training records, production records). All software housing controlled documents and quality records shall be backed up to prevent loss of documents. These software shall be backed up as per the schedule outlined in Compass' Approved Supplier List (ASL), along with the Recovery Time Objective (RTO) for each of these platforms. Physical copies Paper-controlled documents and quality records are stored in a locked cabinet and is accessible only by QA/RA personnel. Paper controlled documents and quality records shall be scanned and stored electronically to prevent deterioration and loss. 6. Controlled and Uncontrolled Documents 6.1 Controlled Documents The currently viewable, approved documents within the DMS are considered “Controlled Documents”. Printed copies, or any electronic copy that is not directly accessed from the DMS, are considered uncontrolled copies, unless clearly marked as a “Controlled Copy”. Controlled documents are identified by: Title Unique document number Effective date and/or revision level Identification of the approver(s) on the cover page and date approved Documented distribution and training as required Document#: QMS-SOP-0002 6.2 Uncontrolled Copies Documents issued to employees and/or outside parties by means other than direct access from the DMS, are considered “Uncontrolled Copies”. Uncontrolled copies shall each be clearly marked “Uncontrolled Copy”, and shall be used for information only, by individuals who are not affected by the document. The individual receiving or personally printing the uncontrolled copy assumes responsibility for the copy, and for ensuring the correct revision upon use. Uncontrolled copies of documents may not be given to personnel or outside parties who manage, perform, or verify work that is directly affected by the document. To mitigate risk of unintended use, uncontrolled copies shall be removed or destroyed immediately on determining that they have fulfilled their informative function and are no longer needed. 6.3 Obsolete Documents A document is obsoleted through a process of placement of the obsolete document in an Archived Document space, only accessible by the DMS Administrator(s) to prevent the unintended use of obsolete documents. Obsolete documents remain retrievable within the specified area of the Document Management System and are retained according to this SOP. Controlled documents are identified by unique numbering, based on the project, document type, a serial number, and a revision. The format is as follows: PROJ-TYP-#### Rev## PROJ Abbreviation of the project, device, classification, or effort TYP Abbreviation of the document type 4 digit zero-filled document serial number, globally unique among all #### controlled documents. Rev## A revision identifier (e.g. A, B, C etc. ) Document#: QMS-SOP-0002 Document serial numbers are assigned by the document management system. The project is determined by the area of application for the document, whether project, company department, or other company effort. This will typically be defined in advance at the planning stage of a project. The type is selected by the author from a pre-defined list of document types within the DMS. The list may be amended from time to time, to add new types as required. Document revision identifiers are assigned by the author based on the document status. Approved and released document revisions are identified by a letter, incrementing from ‘A’. Draft revisions are identified by a number following the letter of the eventual approved revision. Thus, a document with revision ‘B2’ refers to the second draft of the eventual revision ‘B’. The full document number is then based on the author’s selection of project and type, along with the serial number and revision. 8 Control of External Documents Documents of external origin, including forms (e.g. Health Canada MPR form), guidance documents, customer specifications, national regulations, and standards, are maintained within the DMS with document number identifying their type as “EXT”. 9 Process Monitoring 9.1 Internal Documents The QA-RA shall conduct periodic spot review to ensure process is being followed with regard to approval, completeness of signatures, and release of documents. Results shall be communicated to management at each regularly scheduled QMS Management Review meeting. All SOPs and Quality Manual shall be reviewed annually and Review date shall be recorded in the Schedule of Planned Quality Activities (QMS-FRM-2309) for that year. Document#: QMS-SOP-0002 9.2 External Documents QA-RA shall identify the external standards that apply to the business, production, marketing, safety, regulatory and quality activities that affect Compass Health and its employees. The QA-RA shall ensure that the most current versions of these standards are posted for employee use in the DMS and shall replace the document with the newer version as soon as they become aware that a newer version has been issued. If a newer version has been issued, QA-RA will also review relevant operating procedures or work instructions which reference the external documents and update them if needed. A regular review to identify new or revised updates to these documents of external origin shall be conducted by the QA-RA and results reported at each regularly scheduled Management Review meeting. Evidence of review shall be captured in the form of a record showing the version and date of last review. 9.3 Uncontrolled Copies The QA-RA shall conduct periodic spot review to ensure uncontrolled copies are not being improperly used (e.g. as a source of specifications or data for computation). Results shall be presented to management at each regularly scheduled Management Review meeting. 10 Quality Records Record type Description Controlled Master list of all Compass’s controlled documents with their Document List assigned unique document number Appendix A: Document Approval Matrix Document#: QMS-SOP-0002