FEATURED WHITE PAPERS
The White Papers, Research Reports and other custom publications appearing in this area are special advertising supplements intended to inform our readers, and are not created or selected by the Bio-IT World editorial staff.
Absolute Software
A Layered Approach to Computer Security for Healthcare Organizations
With the widespread adoption of electronic health records and laptop computers, healthcare organizations face increased risk of data breaches. The loss of a computer compromises patient privacy, and exposes organizations to damaging publicity and HIPAA compliance challenges. This paper outlines a multilayered approach to computer security, complementing encryption with theft recovery and remote data delete capabilities to ensure the highest standard of protection. Download Now!
Master Control
How Effective Document Management Can Help Accelerate Time to Market
How Effective Document Management Can Help Accelerate Time to Market In the drug
development process, time is indeed money. So it only makes sense to try to reduce delays in
every phase of the process and speed up time to market. But how and where do you begin to save t
ime? This white paper suggests that you start with the most basic activity—document management.
This white paper discusses how effective document management can accelerate time to market
Click here to download whitepaper
Master Control
FDA’s Quality Systems Approach to Pharmaceutical CGMPs
The FDA issued the final version of this guidance on Sept. 29, 2006. It is meant to bridge the gap
between the 1978 Current Good Manufacturing Practice (CGMP) regulations and current quality
systems and risk management approaches. The guidance aims to help manufacturers operate modern
quality systems that are fully compliant with CGMP― specifically 21 CFR Parts 210 and 211―
harmonize CGMP with other quality standards, such as ISO 9000, non-U.S. pharmaceutical
quality management requirements, and FDA’s own medical device Quality System Regulations (QSR).
Click here to download this whitepaper
Master Control
CDER Official Offers Tips on GMP Inspections
Only one of every 10,000 potential medicines investigated by American research-based
pharmaceutical companies passes the rigorous Food and Drug Administration (FDA) approval
process, according to the Pharmaceutical Research and Manufacturers of America. On average, it
takes 15 years of research and development — at a cost of about $800 million — for a new medicine
to get approved. It is no wonder that for many pharmaceutical companies, there are no three letters
in the alphabet more important than F-D-A.
Click here to download the whitepaper
MasterControl
5 Ways To Ensure System Compliance with 21 CFR Part 11
Validation of electronic record-keeping systems is critical to overall compliance with 21 CFR Part 11. The principle behind validation requirement is to ensure accuracy, reliability, and consistent intended performance of the system and to determine invalid or altered records.
Click here to download this whitepaper
Waters 
Streamlining the Chromatographic Method Validation Process
Chromatographic method validation is a critical step in the workflow of pharmaceutical, food safety, chemical, and environmental laboratories. It can adversely impact regulatory compliance, product development, and ultimately product release and availability. Empower 2 Method Validation Manager is a business critical software that reduces the time and costs required to perform chromatographic method validation by as much as 80%. This whitepaper discusses how.
Reduce time/cost to perform chromatographic method validation-free whitepaper!
BIO-IT WORLD BRIEFINGS
The White Papers, Research Reports and other custom publications appearing in this area to inform our readers are created or selected by the Bio-IT World editorial staff.