Articles/Presentations

• DiscoveryAutomation: TheBenefitsof 21CFRPart11 Compliance — Even if the FDA Never Asks for Your Records
• Computer Systems Validation – A Primer- December 2009
• A Layered approach to managing computer validation risks- DIA 2007
• Designing Secure IT Environments for Pharmaceutical Clinical Trial Data Systems- SANS Institute 2002
• Risk Based Approach to Part 11 and GxP Compliance- Agilent Technologies
• Infrastructure Qualification- ABB London
• Validation of Off-the Shelf Software-Master Control
• Some Basic Definitions when we talk about “Software Testing”-Come to Basics Again
• Software Vendor Audits-Life Sciences Leader
• Internal Audits for Pharma and Biotech- Life Sciences Leader
• Impact of ERES on Chnromatography laboratories- Just E-sign on the Bottom Line
• Why Have Coding Specifications-A Management Overview