42Q at the heart of medical manufacturing

As an award-winning MES, 42Q is recognized by medical manufacturers and auditors as a leader in supporting regulatory compliance.

42Q, a cloud-based MES, was designed to meet the operations management and record-keeping requirements of medical device manufacturers, including GAMP5 compliance, 21 CFR Part 11, EU MDR, ISO 13485, and MDSAP. Reduce your compliance costs by replacing paper-based systems with electronic records that can be recalled and audited in seconds.

During an audit or FDA inspection, the ability to produce correct, clear, and verifiable quality records in a timely manner is essential. 42Q supports compliance with key elements of the FDA QSR (Quality Systems Regulation) and ISO 13485. Our Class I, II, and III manufacturing customers use 42Q, the cloud-based manufacturing solution, to ensure they are prepared when the FDA or notified body expects to see:

• Electronic Device History Records (eDHRs) for production of medical devices built within specific date ranges
• eDHRs for products built using components from specific lot codes
• Parametric test data for specific products
• Training records related to a work instruction change as a result of an ECO (engineering change order)

Traceability is critical in medical manufacturing due to the impact on patient safety, recalls, and risk management. The traceability functions in 42Q track product and component genealogy at a granular level, building complete traceability trees that can be viewed from the top-level assembly down to the lowest component.

Employee certification is essential because of the stringent controls required to ensure only correctly trained employees are operating at each workstation. 42Q can integrate with systems that track operator training and certification, and can instantly lock out workstations for operators not certified to work on specific products and processes.

42Q demonstrates its commitment to quality and regulatory compliance through its GxP (Good x Practice) readiness, specifically in the context of GMP (Good Manufacturing Practice). 42Q's GxP readiness is reflected in its meticulously designed processes, infrastructure, and features that align with the stringent requirements of GMP regulations.

42Q is “GxP Ready” as it is designed, developed, validated, and maintained in accordance with GxP requirements. This involves ensuring that the software meets strict quality standards, provides accurate and reliable results, maintains data integrity, and can be audited to demonstrate compliance.