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Gain a practical, science and risk based approach to Process Validation including Equipment Verification
As you are aware, validation is very paper-intensive.
The validation of the atmosphere inside a package provides a sure indication that the thermal seals on the package are correct.
Although these developments satisfy the first and second elements--understanding of the basic biology and toxicology, and platforms amenable for toxicity testing--the third element, validation and regulatory acceptance, has been more difficult.
Before data validation was integrated into gas measurement systems, field engineers and measurement analysts reviewed hundreds of paper records to determine violations or anomalies in the data.
The AES validation test suite is part of NIST's CMVP, which encompasses validation testing for cryptographic modules and algorithms.
Mullen noted that two pharmaceutical engineering and construction industry veterans with more than 50 years of combined experience in facilities validation for FDA approval have joined the company to support the new group.
AVL customers realize many benefits associated with the validation program.
The Validation goal is to keep communication open, to ease anxiety, to help Mrs.
Within three months, the team rolled out ValGenesis, a fully compliant electronic-based system, designed to track validation inventory, streamline validation processes, increase efficiency and ensure compliance.
Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.