21 CFR Part 11 Compliant
42Q Cloud MES was designed specifically to meet the operations management and record-keeping requirements of medical device manufacturers, including GAMP5 compliance. The 42Q solution enables medical device manufacturers to easily meet regulatory requirements and reduce compliance costs by replacing paper-based systems with electronic records that can be recalled and audited in just seconds. As part of this, the traceability functions in the 42Q solution track product and component genealogy at a granular level, building complete traceability trees that can be viewed backwards and forwards. Additionally, 42Q can integrate with systems that track operator training and certification, and can instantly lock out workstations for operators not certified on the latest revisions of work instructions.
During an FDA audit, the ability to produce correct, clear and verifiable quality records in a timely manner is essential. 42Q provides structure for and ensures compliance with key elements of the FDA QSR (Quality Systems Regulation). Our Class I, II and III manufacturing clients use the Cloud-based 42Q manufacturing platform to ensure they are prepared when the FDA expects to see:
- Device History Records (DHR’s) for production of high volume medical devices, built within specific date ranges.
- DHR’s for products built using integrated circuits from specific lot codes.
- Test and parametric data for specific products.
- Training records related to a work instruction ECO (Engineering Change Order).
42Q provides the tools to streamline your daily manufacturing operations in order to ensure constant readiness for FDA audits, as well as other regulatory and quality exercises such as recalls and component material tracking. Move your organization to “evergreen” electronic DHR’s, and ensure that any product rework or subsequent upgrades and repairs are automatically appended and linked to component lot data for complete electronic traceability. Automatically upload test and parametric data and associate it with a specific device serial number or lot number. Integrate with production equipment such as barcode scanners, label printers, and test equipment, and gain complete multi-plant visibility into your operations today.