Technology Solutions Leader Helps Pharmaceutical And Food Customers Comply With FDA 21 CFR Part 11 Guidelines
Columbus, OH - To assist pharmaceutical customers in their ability to meet FDA 21 CFR Part 11 compliance, and food customers in safeguarding food manufacturing processes with improved documentation, METTLER TOLEDO has identified two technological innovations which create electronic records instead of printed documents with handwritten signatures. Freeweight.net 3.2 Quality Management System offers the pharmaceutical and food industries a more robust, one-source Quality Management solution for both packaged product and in-process control, and ID30 combines the latest technology with impressive PC software, creating an unparalleled solution for the most demanding weigh applications.
In the Part 11 guidelines, the "Guidance Document: Electronic Records; Electronic Signatures: Scope and Application (The Guidance Document) recommends that decisions relative to validation, audit trails and record retention be made on the basis of
The Guidance states that manufacturers are asked to specify in premarket submissions the level of concern for the software product and describe how the level of concern was determined.
Further, submissions for any level of concern should contain a device hazard analysis that takes into account all device hazards associated with its intended use. The METTLER TOLEDO Freeweight.net 3.2 Quality Management System makes compliance easy and cost effective, with well defined regulatory assistance programs and additional service options. FreeWeigh.net acts as a quality management system in several areas of specialization. In tablet production, the software provides a simple and reliable means of checking tablet characteristics, such as weight, diameter, thickness, hardness, friability and disintegration. On the packaging line, FreeWeigh.net monitors quality attributes such as expiration date, seal integrity, label position and net content control via random sampling.
"The METTLER TOLEDO FreeWeigh.net software and ID30 terminal are enhanced by the ability to provide efficient validation for the customer," offers METTLER TOLEDO Industrial Business Area Market Manager, Ken Falk. "Statistical quality control systems used in the GMP environment must be legally validated. With ready-made validation protocols, time, money and labor are all significantly reduced."
METTLER TOLEDO is a leading global supplier of precision instruments and is the world's largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. The Company also is a leading supplier of several related analytical and measurement technologies. METTLER TOLEDO Direct Laboratory Service supports a worldwide customer base in more than 100 countries. Additional information about METTLER TOLEDO can be found on the company web site www.mt.com/usa.
Contact METTLER TOLEDO AT 1-800-523-5123, or email indinfo@mt.com or visit www.mt.com/usa. for more information.
Source: METTLER TOLEDO