Gain a practical, science and risk based approach to Process Validation
including Equipment Verification
As you are aware, validation
is very paper-intensive.
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
goal is to keep communication open, to ease anxiety, to help Mrs.
for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells
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.
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.