Compass Health AI SOP: Control of Records PDF

Compass Health AI SOP: Control of Records 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: Control of Records 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-0003 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document#: QMS-SOP-0003 1 Introduction This document outlines the process and responsibilities for control of records at Compass Health including the identification, storage, protection, retrieval, retention, and disposition of records. 1.1 Purpose The control of records is intended to preserve evidence of process, quality, safety and effectiveness, and conformance with requirements in the design, production, verification, distribution, and servicing of medical devices produced by Compass Health. 1.2 Scope This procedure applies to all Quality Records prepared and retained by Compass Health, including those required as outputs of the Quality Management System, and those that are product-related. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.180, 820.181, 820.184, 820.186 - Records ISO 13485:2016 Section 4.2.5 - Control of Records ISO 13485:2016 Section 4.2.3 – Medical Device File ISO 13485:2016 Section 7.3.10 – Design and Development Files Document#: QMS-SOP-0003 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 # Document Controls SOP QMS-SOP-0002 3 Definitions and Acronyms Table 1: Acronyms Acronym Meaning DHF Design History File DHR Device History Record DMR Device Master Record QA Quality Assurance LOP Life of Product QSR Quality System Record Table 2: Definitions Term Meaning Document#: QMS-SOP-0003  The collection of records that a manufacturer is required to establish and maintain for each type of medical device that contains or Design History references the records necessary to demonstrate that the design was File (DHF) developed in accordance with the approved design plan and the quality system requirements for design and development. The collection of records that a manufacturer is required to maintain for each batch, lot, or individual medical device to demonstrate that the device is manufactured in accordance with the DMR. The DHR shall include, or refer to the location of, the following information: (a) The dates of manufacture; (b) The quantity manufactured; Device History (c) The quantity released for distribution; Record (DHR) (d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR; (e) The primary identification label and labeling used for each production unit; and (f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used The collection of records that a manufacturer is required to maintain for each type of medical device containing the following information: Device Master Record (DMR) (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; Document#: QMS-SOP-0003  (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods. Any paper or electronic record that provides objective evidence of Quality System performance of a quality activity or in support of a quality activity. Record (QSR) This may include but is not limited to; forms, reports, documents, contracts, files, pictures, photographs, and charts. A period of time that a record must be maintained in an accessible Retention Period and readable manner. Records maintained in support of the history of product, production, Archive or the quality system. Life of Product The time a given product type is expected to perform to specification (LOP) with normal maintenance and upkeep. Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, Complaint safety, effectiveness or performance of a device after it is released for distribution. Document#: QMS-SOP-0003 Electronic Back- The process, policies and procedures related to preparing for Up/Disaster recovery or continuation of technology infrastructure critical to an Recovery organization after a natural or human-induced disaster. Lifetime of Product dependent, as defined in the product development plan Device 4 Process Roles Role Description of Responsibilities Author/Initiator Preparation of a quality record Administration of this procedure and of the Document Manager (RA Document Management System Specialist) Verifying compliance to this procedure Retention and storage of all documents and records Document Management An electronic storage system used to manage the System versions of documents created at Compass Health Verification of retention period prior to record QA destruction Document#: QMS-SOP-0003 5 Record Control Process All Compass Health quality records shall be legible and shall be stored in such a way that minimizes deterioration, prevents loss and allows them to be readily accessible when needed. All Quality System Records are scanned and filed electronically and stored permanently. Signed originals are retained as per the requirements specified in this procedure for the various categories of records. At a high level, a quality record will follow the lifecycle process shown in Figure 1. Figure 1: Quality Record Lifecycle Process 5.1 Record Categories Records are established and maintained to provide the evidence that products (including devices distributed for investigational testing), processes and the quality system conform to requirements, and that the quality system is effective and efficient. Records are organized into the following main categories (but are not limited to): Device History File (DHF) Device Master Record (DMR) Device History Record (DHR) Medical Device File Quality System Record (QSR) Complaint Files Confidential Health Information More detailed breakdown for each category is included in Section 6, Associated Records, of this procedure. Document#: QMS-SOP-0003 5.2 Establishment of Records Records are established by an author/initiator. The initiator shall be the personnel (one or more people) performing the task, operation, or activity being recorded, if applicable. Forms and/or instructions for establishing a record are provided in procedures and work instructions that call for establishing the particular record. Some forms include a narrative to guide the completion process while others are self-explanatory forms and, therefore, do not require any instructions. 5.3 Completion of Quality Records Only information required by and pertaining to the quality record may be recorded in the quality record. All fields on a form are completed or clearly marked as N/R (Not Required) or N/A (Not Applicable). Any field marked as N/R or N/A shall have a justification as to why it was deemed as such. Only the personnel completing the specified quality requirement is authorized to complete and sign a quality record. Personnel shall use their written or electronic signature to sign all quality records. It is not permissible to backdate or pre-date a quality record. The date recorded with the signature of the individual performing the function must be the current date. On paper quality records, data may be modified by crossing through the incorrect data with a single line and writing the correct data near the original data point. Data modifications are individually initialed and dated. Note: Incorrect information should not be obliterated or removed from the record. 5.4 Identification of Records Records are signed and dated and identify the function and person who established the record. Document#: QMS-SOP-0003 5.5 Indexing and Storage of Paper Records To facilitate their retrieval, records are indexed and grouped. Binders, drawers, and cabinets containing records are clearly labelled (in writing, or logically named directories on the server) with identification of their contents. Departments that establish records are responsible to store and maintain such records, unless designated otherwise. Records are stored in clean and dry locations with controlled temperature to ensure viability. Records shall not be stored in locations that are not commonly known. 5.6 Safeguarding of Records 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's Approved Supplier List (ASL), along with the Recovery Time Objective (RTO) for each of these platforms. Paper Quality Records and printed controlled documents are stored in a locked cabinet, accessible only by QA/RA personnel. Controlled Documents printed and stored in the production area is permissible if the document is clearly marked as a “Controlled Copy” and is stored in a locked cabinet. 5.7 Administrative Provisions Compass Health or Compass Health’s Authorized Representative, shall, for a period ending at least five years after the last product has been manufactured, keep at the disposal of the national authorities: 1. Signed Declarations of Conformity 2. Representative labeling (product/packaging/Instructions for Use) 3. Classification Rationale Statement Document#: QMS-SOP-0003  4. One representative Essential Requirements checklist 5. One representative Essential Principles checklist 6. One representative Risk Analysis document (or summary) 7. Copy of the Standard Operating Procedures for Post Marketing Surveillance 8. Clinical Evaluation Report Summary 9. Copy of the issued certificates Compass Health shall inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. 6 Associated Records 6.1 General Engineering retains these records for five years after manufacturing of the device is discontinued. These records include design project records with their associated plans, schedules, input requirements and reviews. Design verification/validation records include procedures, protocols and verification/validation results. 6.1.1 Design History File (DHF) Records in this file are retained for five years after manufacturing of the device is discontinued. These records are maintained by Document Control. Design project records: Design plans and schedules, design input requirements, and design reviews. Design verification and validation records: Design verification and design validation procedures, protocols, etc., and reports with verification/validation results. 6.1.2 Device Master Record (DMR) Quality Assurance retains these records for five years after manufacturing of the device is discontinued. The DMR shall include: General description of the medical device, intended use/purpose, labeling and any instruction for use Document#: QMS-SOP-0003  Device specifications – appropriate drawings, composition, component specifications, software specifications Specifications for manufacturing, packaging, labeling, storage, handling and distribution. Quality assurance procedures and specifications Production process specifications Procedure for measuring and monitoring Installation, maintenance, and servicing procedure and requirements 6.1.3 Device History Record (DHR) Quality Assurance maintains records in this file for the lifetime of the medical device plus one calendar year, or for five years, whichever is greater. Purchasing records: Purchasing documents for obtaining of materials, components, products, and services to be integrated into the finished product. Product nonconformity and rework records: Nonconforming Product Reports where the decision is to rework or transfer the product. Re-inspection and acceptance of the reworked product are also included. Device verification and acceptance records: Included here are testing and inspection records established using the production work order, including the final acceptance inspection. Device labeling records: Labeling/packaging operations and inspections records and the date and name of the individual performing the inspection. Production (batch) records: Work orders, production reports, etc. 6.1.4 Medical Device File Medical Device File is equivalent to the Device Master Record (DMR) for each medical device at Compass Health. The DMR shall cover all minimum requirements required for a Medical Device File, which includes: a) General description of the medical device, intended use/purpose, labeling and any instruction for use b) Specifications for the product Document#: QMS-SOP-0003 c) Specifications for procedures for manufacturing, packaging, storage, handling and distribution d) Procedure for measuring and monitoring e) Requirements for installation. as applicable f) Procedures for servicing, as applicable 6.1.5 Complaint Files and Device Recall Records Records in this file are retained for five years. These records are maintained by Quality Assurance. Customer complaints log: A log for summarizing and tracking the processing of customer complaints. Customer complaints files: Files with complaints, including records of investigations, resolution with the complaining customer, and communications with regulatory authorities (for reportable events). Advisory notices: Copies of advisory notices and list of customers to whom the notices were sent. Device recall records: Minutes of meetings, memoranda, and other communication and documents established in the course of planning and implementing a device recall. 6.1.6 Sales and Distribution Records Records in this file are retained for the lifetime of the medical device plus one calendar year, or for five years, whichever is greater. These records are maintained by Top Management. Sales records: Offers, sales orders, and other documents established in the course of processing, negotiating, and implementing contracts and orders; in particular, records of contract/order review. Device distribution records: Records shall be kept for both software and hardware devices. Document#: QMS-SOP-0003 Hardware Distribution Record The Operations Representative shall create and maintain clear and up-to-date distribution records for the hardware medical devices. The distribution records for hardware devices shall provide detailed information about each product, including: 10. Sales Order Number 11. Name and Address of consignee(s) 12. Lot number or Serial Number of the device 13. Shipment date 14. Quantity shipped 15. Additional control number(s) (if applicable) Software Distribution Record Compass’s Engineering and Customer Success teams shall create and maintain clear and up-to-date distribution records for each device that is provisioned to facilitate an efficient response to notification of a defective unit and, in turn, help expedite the recall process. The distribution records for software medical devices shall provide detailed information, including: 16. Device name 17. Device identifier 18. App Version Installed 19. Control/ Part/Product Number(s) (If applicable) 20. Installation date 21. Name of company/ person supplied with the device(s) 22. Name and address of consignee(s) 6.1.7 Retention Periods Quality system documentation: Quality Manual (QM) and Quality System Operational Procedures (OPs), associated work instructions and forms including obsolete copies of these documents. Distribution of these documents and the storage location and retention periods for any obsolete copies is defined by SOP: Document Controls (QMS-SOP-0001). Document#: QMS-SOP-0003 Internal quality system audit reports: Quality Assurance will retain and maintain Internal Audit Reports, including audit findings and associated corrective and preventive actions records for five years. Corrective and preventive action records: Quality Assurance will retain and maintain copies of corrective and preventive action requests (CAPAs) records for five years. Management review records: Quality Assurance will retain and maintain records including: minutes of management review meetings and other management review input and output documents for five years. Training records (Competency, Awareness and Training): Human Resources and departments conducting training will retain and maintain personnel training records for five years after termination of employment. Subcontractor evaluation and performance records: Included here are documents demonstrating subcontractor quality capability and quality performance. Purchasing (or designee) will retain and maintain these records while the subcontractor is active plus five calendar years. Manufacturing Equipment (or software) maintenance records: Engineering will retain and maintain maintenance plans, logs and reports records for five years. Distribution Records: Record retention period for distribution records shall be before the longer of (a) the projected useful life of the device, or (b) two years after the date the device is shipped. Where not specified above, the following retention periods shall apply: Non-product specific records shall be maintained for a minimum of 5 years. Product specific records shall be maintained for the LOP, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer 6.2 Disposal At the end of the established retention period, records are no longer required to be stored and may be destroyed. Before destruction of records, the records are to be reviewed by QA who will authorize the destruction. Disposal will be done in a manner that will maintain the security of the record data. Destruction date and the name of the individual performing the destruction shall be recorded at the time of the destruction. Document#: QMS-SOP-0003 7 Process Monitoring 7.1 Storage and Safeguarding of Records The Document Manager (RA Specialist) shall conduct periodic spot review to ensure process is being followed regarding permissible storage locations, clear labelling, legibility, identification, and safeguarding. Specifically, backups shall be inspected for schedule completeness and integrity. Results shall be communicated to management at each regularly scheduled QMS Management Review. The Regulatory Affairs Specialist shall also review Production records to ensure legibility, completeness and good overall documentation practices monthly. 7.2 Retention and Disposal The Document Manager shall conduct periodic spot review of QSR destruction records, to ensure destruction of records occurs following expiry of the defined retention period. Results shall be communicated to management at each regularly scheduled QMS Management Review. 8 Quality Records Record type Description Device Master See definitions and Section 6.1.2 above Record The collection of records for each type of medical device that contains or references the records necessary to demonstrate that Device History File the design was developed in accordance with the approved design plan and the quality system requirements for design and development. Document#: QMS-SOP-0003  The collection of records for each batch, lot, or individual medical Device History device to demonstrate that the device is manufactured in Record accordance with the DMR. Any paper or electronic record that provides objective evidence of Quality System performance of a quality activity or in support of a quality activity. Record This may include but is not limited to; forms, reports, documents, contracts, files, pictures, photographs, and charts. Medical Device See Section 6.1.4 above File Document#: QMS-SOP-0003