21CFR part 11 requires validation for all systems
that govern cGXP process - be it current Good Manufacturing
Practices, Good Laboratory Practices, or Good Clinical Practices.
Starting with comprehensive guidelines from FDA, this article
explores "easy-to-implement" framework for systems validation
and the best practices. Read
The sticker shock of 21CFR Part 11 compliance to a company could range from $5 million to a hefty $400 million. This article delves into some issues in 21CFR part 11-system requirements, discusses a risk-based methodology to create a roadmap and identifies most popular first steps. Read More ...
Is your company spending resources in manufacturing
scraps? The quality department of a manufacturing company with
annual sales of $250 million, calculated the total cost of repair,
rework, scrap, service calls, warranty claims and write-offs
to be in excess of 20% of their sales. So one day every week,
the company spent its time manufacturing waste. Read
While Many books and articles have
been written about how to drive greater management and organizational
output, only recently managers are being asked to incorporate
"audits" as a management tool. How does one incorporate audit
best practices to manage day to day operations? Read
"The notion that medical device companies
must maintain robust quality assurance systems to achieve regulatory
compliance is not a new one. What is new, however, is the opportunity
for medical device companies to transform regulatory compliance
from a disparate set of cost center activities to a core element
of their most strategic and profit-focused product initiatives."
- Forbes IT Research
"In many industries, competitive advantage
is rapidly shifting to the management of suppliers, which can
account for as much as 60 to 80 percent of manufacturing costs.
Companies that effectively involve suppliers in their internal
product development achieve a new strategic advantage."
- The McKinsey Quarterly
"Excellent firms don't believe in excellence,
only in constant improvement and constant change."