Purchase the Title 21 CFR Part 11 Compliance Guide CD-ROM online for $298.00 from IndustryMatter.com titled "Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11: With Clear Recommendations for Corrective and Preventive Actions." This guide in CD-ROM format was produced from a web seminar conducted by Dr. Ludwig Huber, an expert in the field of FDA and equivalent international compliance and ISO/IEC 17025-laboratory accreditation.

This is an important reference tool for pharmaceutical manufacturers, drug makers, medical device manufacturing businesses, biotech firms, developers of biologics, and other FDA-regulated industries. This comprehensive guide to computer validation compliance is a valuable resource for pharmaceutical industry executives who want to avoid receiving warning letters from the Food and Drug Administration (FDA). 

Pharmaceutical companies, as required by 21 CFR Part 11, must maintain a secure environment that must be validated to maintain electronic signature integrity. This Title 21 CFR Part 11 Compliance Guide is a valuable resource tool for laboratories that want to prepare for FDA Part 11 Inspection of data integrity, computer systems, e-records and to avoid FDA warning letters.  Learning from recent FDA warning letters related computer validation and to 21 CFR Part 11 is a good strategy for pharmaceutical manufacturers. This CD-ROM Part 11 compliance guide provides concise recommendations for corrective and preventative actions. Click here to read the FDA PDF titled "Guidance for Industry, Part 11, Electronic Records; Electronic Signatures — Scope and Application".