20 - Introduction to the FDA Process Validation
Beyond compliance, validation
can offer significant business value and can be considered as somewhat of a "legal best practice" in providing traceability and accountability within business processes.
These can range from the integrity of a glass vial to the presence of bubbles in liquid fills; and at the same time perform a packaging film validation
process, a gross over-under fill validation
of the presence or absence of a tablet or pill, and even container atmosphere validation
It is likely that subsequent validation
and acceptance of alternatives will have a shorter timeline because assays such as LLNA have paved the way, but probably not by much.
With each validation
role violated, the number of discrete exceptions, especially for hourly meters, could be a page in length, requiring tiresome acknowledgement of many individual exceptions.
Naomi Feil, MSW, ACSW, is Director of The Validation
Training Institute, a caregiving consultation firm based in Cleveland OH.
Commentary on the US Food and Drug Administration's 2011 "Guidance for Industry, Process Validation
General Principles and Practices"
Provides real-time validation
status and eliminates excessive time for tracking validation
status and documents
The question is, how does validation
change when ERP systems are deployed in a virtual systems environment?
is necessary to confirm the relationship to the target disease in large numbers of patient samples and requires highly standardized protein measurement systems.
As per ISO 8402:1992, validation
is defined as "confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled.
Nasdaq: CALD) has announced the validation
of Oracle9i Database for Linux on Caldera Open UNIX 8.
The Institute of Validation
Technology, a division of Advanstar Communications, has announced its 14th Annual International Validation
Week - the industry's longest running and most comprehensive event dedicated to validation
a world-class leading provider of Validation
Lifecycle Management (VLM) software solutions, today announced that Shire HGT has implemented ValGenesis software as its platform for validation
Within the life sciences community, the mere mention of the word "validation
" sets off discussions filled with validation
jargon and acronyms such as IQ, PC), OO, predicate rules, GAMR and other related verbiage.