From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
With more than 20 years’ experience and currently more tha… Read More »
Title 21, Code of Federal Regulations, Part 11. Part 11 established the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA.… Read More »
The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21 parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing… Read More »
Hardware and software applications in which a company has already invested considerable time and money. Legacy systems typically perform critical operations in companies for many years even though they may no longer employ state-of-the-art technology… Read More »