Industry > Pharmaceutical
Pharmaceutical
Spectrum is a unique off–the–shelf software solution for quality operations management and monitoring that is unmatched in the pharmaceutical industry. Spectrum’s fully-integrated quality solution combines traditional quality operations with the most advanced Statistical Process Control (SPC) tool, which complies with the most stringent international regulations – including cGMP, GLP and FDA 21 CFR Part 11 regulation (Electronic Records and Electronic Signatures). |
|
The pharmaceutical industry is under intense pressure to decrease the cost of drugs. The stringent compliance requirement and the difficult business environment drive mergers and acquisitions, and are creating a bottle neck for the industry. Spectrum provides the ease to add any number of products, procedures and testing methods whilst maintaining existing data integrity, and ensuring internal and external compliance. To be successful, every organization must constantly reduce costs and increase efficiency, comply with regulatory requirement, and increase throughput. Spectrum provides the required integrated approach to product quality, cost efficiency, compliance and process optimization.
|
The Spectrum solution is focused on identifying and reducing waste and inefficiency, monitoring variation, managing time and resources, and organizing and managing the complete testing and quality operation. The system is designed for analyzing and controlling manufacturing through timely measurements (i.e. during processing) and complete reporting and trend analysis of critical quality and performance attributes of materials and processes, with the goal of ensuring the final product quality. The solution provides comprehensive traceability (through audit and monitoring controls), and state-of-the-art risk assessment. |
The core functionality of the Spectrum LIMS solution provides an integrated approach to managing the comprehensive functionality of the additional modules, such as Stability, Lab Inventory, Instrument Interfacing, Instrument Calibration, Reagent Management, Dispensing and Statistical Process Control. Spectrum comes with pre-configuration and validation scripts that streamline the implementation and validation of the solution, further reducing the overall quality cost, and improving pharmaceutical laboratory efficiency and productivity.
|
