Within a structured quality management system, if changes occur in the inspection specifications, such as characteristic tolerances, formulas, or test equipment assignments, then the documentation must support each mutation in a logbook to create an audit trail. GUARDUS CAQ modules ensure data changes are automatically forwarded to the quality team’s members and are released according to the “2-3-4 man rule.” Electronic signatures, via a user name and a password, safeguard the releases so that they are carried out only by authorized employees.
The planning of quality inspections along the value chain represents the central element in the GUARDUS MES quality management. The role of inspection planning is to establish all of the product and process characteristics that must be systematically monitored and respectively controlled during the manufacturing process. This is possible if detailed information such as specifications, images, and CAD drawings from design or detailed specifications about inspection methods and test equipment flow through to the inspection plans.
In order to carry out the paperless management of these inspection specifications, biotech companies must comply with strict regulations, such as the FDA 21 CFR Part 11, which states that each user action creating or modifying electronic records must be securely recorded with a time stamp as well as the value before and after the modification. GUARDUS Solutions’ manufacturing and quality management software has a built-in audit trail function that provides such an audit trail. Thus, every change in the inspection specifications will be exactly recorded in the inspection planning. Besides this automatic documentation, there is also a release process that systematically supports the 2-3-4 man principle according to the requirements. Only after the official release is the modified inspection plan set as “in-production”
The scope of the 21 CFR Part 11 regulation also provides guidelines for personal identification by means of electronic signatures. Besides the biometrical systems, the authorized procedures are based on various identification mechanisms, such as a user ID and a password. This is why GUARDUS MES is the best solution for supporting the whole change and release process by means of electronic signatures.
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About GUARDUS SOLUTIONS AG, with its offices in Germany, Canada, and Romania, is an internationally renowned software developer specialized in software simplifying manufacturing execution and quality management.
GUARDUS Solutions AG’s truly paperless manufacturing operations management solution gathers data from every corner of your enterprise to give every individual involved with the production floor the information needed to reap the rewards of increased productivity and quality and drive continuous improvement.
Our experience is delivering information from the back office to the shop floor for better clarity at every level of the organization. Discreet manufacturers in the Aerospace, Automotive, Electronics, Medical Devices and Plastics industries benefit from our time proven solutions every day.