Life Sciences firms are subject to an immense and demanding set of Quality regulations. Having the right Quality and Compliance tools can make the difference between efficient manufacturing and a potential disaster. A successful Life Sciences firm therefore needs a flexible system to meet authority standards (FDA, EMA etc.) and internal procedures without bogging down production. Following are some of the main functions that must be met by Quality systems.
Life Science firms must be able to identify, implement, and audit performance regarding the regulations that apply to their products and services. Companies also have a set of internal standard operating procedures that must be upheld. The Quality and Compliance processes seek to ensure that various aspects of production operate under the appropriate conditions. These aspects include:
Internal Sites – Activities within the manufacturer’s own facilities
Contract Manufacturers and External Suppliers – As an increasing number of companies rely on outsourced manufacturing and products supplied by third parties, it has become essential to monitor the quality standards of outside organizations
API and Pharmacovigilance – Pharmaceutical development and usage require intense monitoring at all times
Innovative and Generic R&D – Regardless of whether a company is developing an original life science product, or is using generics, R&D practices must be tracked throughout the product lifecycle