Due to the legal regulations and concerns for patient safety, strict monitoring of quality criteria is a necessity to the medical technology industry. The use of coordinate measuring machines (CMMs) in monitoring the manufacturing processes requires special considerations for medical device companies. According to the Code of Federal Regulations Title 21, Part 820.70 and Part 820.72, it must be ensured that all inspection, measuring and testing equipment is suitable for its intended purpose and produces valid results. Each manufacturer must therefore define and maintain processes to ensure the equipment is routinely inspected and serviced. Validation activities and results must be documented. MEETING GXP QUALITY GUIDELINES The principle determination of a CMM’s suitability can be ascertained based on appropriate validation documentation. At the very least, such documentation should contain internal approval documentation, quality management certificates, e.g. according to DIN EN ISO 9001, 14001 and 17025, calibration certificates, process documentation, notes on setup and use and declarations of conformity. Procedures for determining measuring uncertainty, inspection capability and measurement system analysis (using GR&R testing) can be used for taskspecific inspection. CMMs used in the medical device industry must be subject to regular calibration and typically annual maintenance. Some CMM manufactures have the capability to provide maintenance schedules based upon activity and device load. At Carl Zeiss, we use a software tool called Master Control Center (MCC). In this example, we use predictive tools such as Probe Collision data (Fig. A) to help determine needed service intervals (Fig. B). The FDA has significantly changed the validation procedures required over the past years. Particular focus has been placed on the product and process knowledge; which are both crucial for ensuring high product quality and the associated high level of patient safety. Up until now, the fixed development model (V model) was considered the standard for developing computer-assisted systems for the regulated industry. Today, it is only one of numerous models in the Good Automated Manufacturing Process (GAMP 5). All lifecycle models that allow quality to be developed into the system (quality by design) are now accepted. Consequently, agile software development models are allowed. Here, agile means that it is not necessary to first compile and sign complete requirement specifications Before the engineering specifications and the subsequent draft specification are prepared. Requirement specifications can first be prepared in a rudimentary manner and later revised. During this time, the development of the system can already be started. GAMP 5 even recommends keeping documents in the draft stage, in other words, easily editable for a long time. AUTOMATICALLY SAVING THE INSPECTION RESULTS ELECTRONICALLY The most detailed regulations for the measuring process affect how the measured results, or measurement records, are handled. Since measurement records must essentially be electronically processed in an automatic test environment, the entire process is largely subject to the electronic document regulations according to 21 CFR Part 11. Here, Part 11 takes into account that the risk of manipulation, misinterpretation and untraceable changes is higher with electronic records than with conventional paper records, or is more difficult to detect. As a result, additional measures are required. At Carl Zeiss, we use MCC to track measuring part programs (Fig. C). The ability to electronically recall the current published version as well as previous and blocked versions meets the strict FDA standards for documentation. Medical device organizations must take control of their quality process with appropriate technology solutions. FDA–compliant software allows for risk reduction, greater complexity in the manufacturing process, and expanded innovation in the medical device industry. For more information please contact Chris Bomgaars, Strategic Account Manager – Medical, Carl Zeiss Industrial Metrology, LLC at firstname.lastname@example.org.
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