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Quality Agreements: The Essential Items for Contract Manufacturers
After the recent announcement and publication of Article 47 of Directive 2001/83/EC on the...
Document Retention: Regulatory Guidance
This article gives a general overview of the document retention periods as indicated by...
The 3 C’s: Impact on Vendor Qualifications in Bio-Pharmaceutical Industry
The biopharmaceutical industry is developing quickly and the quality systems are getting increasingly stringent...
The 3 Steps to Awesome Design Qualifications
DQ covers all aspects of the design and procurement of facility and equipment. It...
Airlocks – The Ventricles of Cleanroom
In Pharmaceutical, Bio-Pharmaceutical and sterile manufacturing, the clean room environment is the major prerequisite...
How We Contaminate Clean Rooms?
Of the many potential sources of contamination in cleanrooms and other clean manufacturing environments,...