Paperless medical device manufacturing

Modern manufacturing execution systems (MES) help medical device manufacturers achieve efficient, competitive production; deliver new product developments as quickly as possible; and ensure high quality and complete traceability to meet regulatory demands. MES strategic tools facilitate innovation and provide security for the future of the business.

Bye bye paper

MES can replace paper-based processes and records throughout the shop floor with completely electronic systems. Compliant with the requirements of the U.S. Food and Drug Administration (FDA) title 21 CFR Part 11 for electronic records and signatures, modern MES remove inefficient handling of paper records and enable integration of multiple processes and data. This can improve overall plant efficiency, reduce re-work, increase yields, optimize process cycle times, improve delivery fulfilment, and enhance product quality.

The FDA is encouraging businesses to use electronic systems for continuous process improvement to reduce the number of regulatory actions, recalls, and manufacturing related incidents. The FDA initiative, the Case for Quality, is intended to engage medical device manufacturers to focus resources on product quality rather than compliance.

Reviewing and archiving paper-based data is prone to error. Performance analysis can only be done after processing, delaying capture of non-conformances. Measuring overall productivity, efficiency, and process performance is difficult; and advanced engineering analysis nearly impossible. Integrated electronic data capture and self-auditing processes contained in MES lead to continuous process improvements, built-in quality, production consistency, and actionable information.

Traceability

A modern MES solution provides end-to-end product traceability, meeting mandates to show all materials, components, and assemblies meet specification and processing requirements. It can track complex production processes and incorporate products being batched, split, merged, or inserted as components in new assemblies along with managing all back end and assembly processes.

Reducing painful audits

Automatically logging data throughout the production line makes regulatory compliance an outcome of the process rather than a separate activity. The system provides complete, secure electronic Devices History Records (eDHR) and electronic records and signatures in line with FDA 21 CFR Part 11.

Complete audit trails for traceability of every process step and parameter includes equipment, maintenance, and calibration status and certification management of personnel and equipment. With correct access permissions, records are accessible via the system interface. Data can be exported for inspection, review, and copying. Changes at all levels are recorded in the system history and are fully traceable with an in-line time-stamp history.

Summary

The decision to invest in a modern MES can allow a business to evolve as it needs to in the future, while harnessing and analyzing masses of processing data – producing valuable, intelligent information on which to base sound strategic decisions and product roadmaps.

Critical Manufacturing
www.criticalmanufacturing.com