Compass Health AI Labelling and Packaging SOP (QMS-SOP-0018) PDF

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

Compass Health AI SOP: Labelling and Packaging 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 Rushabh Approver 02-Jan-2024 Head of Gudka Product Document# QMS-SOP-0018 Revision History Version Date Description 1.0 03-Jan-2024 Initial Release Document# QMS-SOP-0018 1 Introduction The purpose of this procedure is to provide instructions—which shall address the mandatory language requirements of relevant geographical regions wherein Compass HealthAI Inc.’s (“Compass') devices are authorized for sale as well as the appropriate usage of relevant certification marks, whenever applicable — and a system for controlling product labelling and packaging and their application. 1.1 Scope This procedure applies to the labelling, packaging and related Compass processes of finished Compass-manufactured product authorized for sale in Canada and the USA. This procedure also applies to labelling of investigational medical devices. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.120 Labelling and Packaging Control Canadian Medical Device Regulation (CMDR-(SOR/98-282)) Section 21-23 Labelling Requirements Australia’s TG(MD)R 2002 and Regulation 10 ISO 13485:2016 Section 7.5. Production and Service Provision ISO 15223:2021 Symbols to be used with Medical Device labels, labeling and information to be supplied Document# QMS-SOP-0018 2.2 Reference Documents Document Title Document # SOP: Control of Records QMS-SOP-0003 SOP: Product Development QMS-SOP-0007 SOP: Production QMS-SOP-0012 SOP: Purchasing QMS-SOP-0015 SOP: Verification of Purchased Product QMS-SOP-0019 SOP: Control of Non-Conforming Product QMS-SOP-0024 WI: Translation QMS-WI-0095 3 Acronyms and Definitions Acronym Description All associated proprietary logos and artistic designs (version screens, as Artwork part of the application) included on Compass' labelling and packaging. Device Master Record Index contains reference to the labelling and DMRI packaging specifications and associated work instructions. Document# QMS-SOP-0018  Promotional All textual content presented on the website, company/product Materials literature, news/press releases etc. 4 Process Roles Role Description QA-RA Responsible for spot checking labelling activities periodically Operations Personnel designated as qualified to perform packaging activities. Responsible for developing and validating marketing materials as Marketing labelling Responsible for creating physical packaging (e.g. dielines) and Engineering electronic labelling 5 Packaging and Labelling Process 5.1 General Product packaging and labelling are integral parts of Compass' products. The product is not completed and cannot be released for distribution before it is packaged and all specified labelling is applied and incorporated into the product. Labelling and packaging shall adhere to all relevant requirements of the quality management system that apply to products and production processes, specifically, the operational procedures and other quality system documentation related to: Design control, including design validation and control of design output and changes Document# QMS-SOP-0018  Control of processes for packaging and labelling, to include personnel training, process validation, work instructions, process monitoring, and process records Inspection and final acceptance of packaging and labelling Establishment and maintenance of necessary records All promotional materials with medical device claims shall be reviewed and approved by QA-RA prior to release to external sources. 5.2 Labelling and Packaging Requirements, Design and Validation During the phase of product design, labelling, packaging, and associated artwork are developed. The development processes are implemented in accordance with SOP: Product Development Process. 5.2.1 Product Labelling Requirements The following labelling requirement shall be met, when applicable. The name or trade name and address of the manufacturer. The details strictly necessary to identify the device and the contents of the packaging especially for the users; Where appropriate, the batch code, preceded by the word ‘LOT’ or the serial number; Where appropriate, an indication of the date by which the device should be used, expressed as the year, month, and day (YYYY-MM-DD format); If the device is custom-made, the words “custom made device” Any special storage and/or handling conditions; Any special operating instructions; Any warnings and/or precautions to take; Where appropriate, the word ‘STERILE’; Where applicable, method of sterilization; Where applicable, the correct Unique Device Identifier (UDI) If the intended purpose of the device is not obvious to the user, Compass shall clearly state it on the label and in the instructions for use; Document# QMS-SOP-0018 Note: Compass does not develop sterile devices, nor devices containing a human blood derivative. For Australia This is the information required with every Medical device sold in Australia. Labelling Information required by TGA 1 The manufacturer's name, or trading name, and address 2 The device's intended use, the intended user, and the kind of patient it's intended for. If this information is not obvious. 3 Provide enough information so the user can identify the device, or packaging contents. 4 Any particular handling or storage requirements applying to the device 5 Any device warnings, restrictions, or precautions 6 Any special operating instructions for the use of the device 7 If applicable, a single use only indication 8 If the device is specifically made for one person or health professional, it should only be used by them. An indication that the device has been custom-made needs to be included. 9 If applicable, an indication that: a. The device is intended for premarket clinical investigation if it's not an IVD; or Document# QMS-SOP-0018 Labelling Information required by TGA if the device is an IVD medical device, it is only intended for performance evaluation. 10 For sterile devices, the word 'STERILE' and how it was sterilised 11 The batch code, lot number or serial number of the device 12 Provide the date (month and year) until which the device can be used safely, if applicable. 13 If the information provided with the device does not include the information mentioned in item 12-a statement of the date of manufacture of the device. This may be included in the batch code, lot number or serial number of the device, provided the date is clearly identifiable. 14 If applicable, the words 'for export only' Additionally, the label should also have the Name and address of Australian Sponsor (for devices sold in Australia), per Regulation 10.2 5.2.1.1 Electronic Labelling Instructions for use may be provided in electronic form only. When this occurs, Compass shall: Maintain the instructions for use in electronic form for a period of 5 years after the last device has been manufactured If special hardware or software is required to display the instructions for use, the device support information shall provide information on the software and hardware requirements needed to display the instructions for use Document# QMS-SOP-0018  Provide the instructions for use through a stable website, using freely available software. This website shall indicate in which languages Compass provides the instructions for use. This shall be completed prior to product release. 5.2.1.2 Investigational Testing Devices In addition to the product labelling requirements listed in Section 5.2.1, product versions distributed for investigational testing shall have the following additional labelling requirements met: 5.2.1.2.1 Health Canada The following statements shall each be clearly visible to the user for investigational devices in Canada: “Investigational Device. To be Used by Qualified Investigators Only. The performance specifications of this product have not been established.” “Instrument de recherche. Réservé uniquement à l'usage de chercheurs compétents. Les spécifications de rendement de l'instrument n'ont pas été établies.” 5.2.1.2.2 FDA The following statements shall be clearly visible to the user for investigational devices in the United States: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use. 5.2.1.2.3 Australia An indication that on the label that the device is intended for premarket clinical investigation. Document# QMS-SOP-0018 5.2.2 Product Packaging Requirements If a product has specific packaging requirements for product being shipped out of Compass, packaging is done per the relevant work instruction (as referenced in DMRI). 5.2.3 Product Labelling and Packaging Validation The following product labelling and packaging validation is performed: For physical labels, labelling integrity is validated to ensure that labels will remain in place and be legible under normal operating and usage conditions per the relevant work instruction. For packaging, packaging integrity is validated as part of the design, according to acceptable international shipping standards to ensure that packaging materials maintain their integrity throughout assembly and cleaning processes, shipping and storage. Compass' labelling and packaging are validated through the relevant work instructions. For electronic labelling, this validation shall include: Ensuring the instructions for use do not impede the safe use of the device o Ensure the proper design and functioning of the instructions for use in electronic form (e.g. legibility of instructions for use not compromised by standard interaction tools such as zoom) o Ensure the product version number is available to the user o Ensure Compass' contact information is available to the user 5.3 Receiving Inspection and Storage All of the required components for packaging and labelling are purchased according to the SOP: Purchasing. The received items are inspected visually to identify overt signs of damage or any missing components or incomplete documents once the material arrives at Compass Health. Incoming inspection and storage controls pertain to user materials (examples include: user manual, appropriate (current revision level) art work, marketing literature or booklets). The relevant work instructions detail the instructions for inspecting the label material. Document# QMS-SOP-0018 5.4 Receiving Inspection Receiving labelling/packaging inspection includes verification that: The materials and printing (e.g. user manual) comply with specifications, Correct control numbers are used (for parts/products with control numbers). Inspection is performed per SOP: Verification of Purchased Product. The details of the incoming inspection and the inspection results shall be inputted in the Incoming Inspection Form (QMS-FRM-0069). If the inspection fails, the product is non-conforming and SOP: Control of Nonconforming Product is followed. 5.5 Production Storage The designated Product Storage area at Compass is used to ensure safe storage of inspected and accepted labels and packaging. This designated area is maintained by Operations team and monitored by QA-RA to ensure proper usage of such materials. 5.6 Packaging and Labelling Operations Packaging and labelling operations and processes are considered to be both design and production processes. All process control requirements and procedures that apply to design and production also apply to packaging and labelling. Specifically, the operational procedures and other quality system documentation related to: Design transfer, e.g., development of packaging and labelling processes Process work instructions Process control and monitoring activities (including qualification of the labelling processes) Inspecting and testing the packaging applied to the label. Prior to initiating new labelling operations for a new physical product, the Operations personnel shall ensure that the workspace is free of any materials relating to past labelling Document# QMS-SOP-0018 operations to minimize labelling errors such as the application of incorrect control numbers to new products. 5.7 Language Requirements The user manual (instructions for use), safety instructions, training checklist (if applicable), related promotional materials and software displays corresponding to Compass-made individual devices for sale in Canada, Australia and the USA shall be written in English. Compass shall translate these materials to French if requested by a Canadian customer as outlined in the WI: Translation (QMS-WI-0095). Additionally, directions for use in the other official language in other jurisdictions shall be made available by the manufacturer as soon as possible at the request of the purchaser. 5.8 Assembly The production (see SOP: Production) applies to packaging and labelling operations. The relevant assembly work instructions for the product (referenced in the DMRI) detail the packaging and labelling configurations, labelling operations, and inspection required during assembly, if appropriate. 5.9 Packaging and Labelling Packaging and Labelling for each product are specific to product, model number, and/or size. Packaging and include final inspection. Please refer to the relevant work instructions. 6 Process Monitoring QA-RA shall periodically monitor packaging operations by spot-checking packaging specifications, artwork prototypes, and inventory products, as well as documentation of inspection and packaging operations. Document# QMS-SOP-0018 Results of such checks shall be made available to Management at Management Quality Reviews. 7 Quality Records Record type Description Purchase and Receiving Contains details of Purchase and receiving activities, Log including product inspection results Record of labelling/packaging inspection and the date and Labelling/Packaging name of the individual performing the inspection. For software Inspection Record products, this is performed during verification testing (refer to the specific product’s test specification). Drawings, specifications, parts lists, artwork, work Labelling and Packaging instructions, and other such documents defining the labelling Specifications and packaging and the associated operations. Document# QMS-SOP-0018