IMPLEMENT FASTER BE PROACTIVE NOT REACTIVE PREVENT RISK Nova-LIMS has enabled laboratories to cut back manual and time-consuming activities and has empowered pharmaceutical and biotechnology organizations to achieve objectives such as decreasing product time to market while ensuring regulatory compliance. Over the years, the importance of system integration and automation has drastically increased, thus placing…
Pharmaceuticals and regulated industries need to comply with multiple sets of regulations and guidelines imposed by various global regulatory agencies such as FDA, EMEA, EPA, TGA and OSHA. In addition to these regulations, established practices such as cGMP, GLP, 21 CFR Part 11, GAMP and GCP must be followed. The complexity of these guidelines presents…
ENSURE ENTIRE PROCESS FROM A TO Z STATISTICS SHELF-LIFE | P-VALUE ARRHENIUS MANAGE STABILITY STUDIES Determining of the shelf-life of a pharmaceutical product is critical for understanding how long that product can maintain original quality specifications. Product used after the expiration date can negatively impact a patient. For this reason the shelf-life determination must be accurate.…
