Medical Device Industry

With demanding regulatory compliance requirements, increased competition and higher costs, most Medical Device companies aim to improve efficiency levels through methodologies such as CAPA (Corrective and Preventive Action) and Six Sigma.

As such, factors including reduced cycle time, shorter time to market, improved quality, increased productivity and reduced unit costs are becoming today’s most challenging goals for Medical Device companies.

Fraysen Systems supports these goals by effectively capturing, integrating and presenting data as a standard picture to enable staff including supervisors, operations, engineering and six sigma specialists to identify non-conformances and take corrective action. Because ProcessPlus™ captures and stores this non-conformances data, the team can ‘learn’ from these problems to prevent them occurring in the future.

ProcessPlus™ is embracing the need for electronic recording of data in lieu of manual record keeping. Designed to cope effortlessly with vast amounts of disparate data, it facilitates greater data availability and accuracy, which is key to regulatory compliance procedures such as FDA CFR Part 11 and the newer Process Analytical Technologies (PAT) regulations. ProcessPlus™ enables the investigator to drill down to historical records and so presents a full audit trail for the Customer. Fraysen Systems’ realizes that each customer has unique processes and therefore interpretations of rules to meet with these regulations. It is developed to precisely adapt to the needs of the Customer in line with shifting environmental pressures.

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