Novatek International software

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. The stability studies required to evaluate shelf-life can take several years to complete. Mistakes made during this process can result in repeating an entire study resulting in long delays getting the product to market.

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 a number of adherence difficulties to manufacturers, and increases their overall commitment to compliance.

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 Nova-LIMS at the forefront of process harmonization and data centralization.   Nova-LIMS allows for accountability and reliability between inter-related and interdependent departments.  It provides the entire organization and their respective customers’ seamless integration between laboratory testing, scheduling, data collection, and real-time reporting. Unique to Nova-LIMS is the interface for seamless communication between LIMS and Quality Management Systems.