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Quality Management Technology Solutions

To assist pharmaceutical customers in meeting FDA 21 CFR Part 11 requirements, and food customers in safeguarding food manufacturing processes with improved documentation, two technological advances have been identified that creat electronic records instead of printed documents with handwritten signatures. The Freeweight.net 3.2 Quality Management System offers these industries a more robust, one-source Quality Management solution for both packaged-product and in-process control, while ID30 combines the latest technology with PC software, creating a solution for demanding weigh applications. In the Part 11 guidelines, the Guidance Document recommends that decisions relative to validation, audit trails, and record retention be made on the basis of predicate rule requirements; impact on product quality, safety, and record integrity; and a justified and documented risk assessment. Manufacturers are asked in this document to specify in premarket submissions the level of concern for the software product and describe how the level of concern was determined. Freeweight.net 3.2 makes compliance simple and cost effective, with well-defined regulatory assistance programs and additional service options. In tablet production, the software checks tablet characteristics such as weight, diameter, thickness, hardness, friability, and disintegration. On the packaging line, it monitors quality attributes such as expiration date, seal integrity, label position, and net content control via random sampling.
Mettler Toledo
1900 Polaris Pkwy.
Columbus, OH, 43085