Life Sciences firms are subject to an immense and demanding set of Quality Compliance regulations. Having the right Quality Compliance tools can make the difference between producing efficiently and being subject to a potential disaster. A successful Life Sciences firm therefore needs a flexible system to meet FDA/CE and internal standards without bogging down production. Following are some of the main functions that must be met by Quality Compliance systems.

Following are the topics covered by Generica QMS, KCS’ product for Life Science firms.

Quality Compliance

Life Sciences 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 Compliance process seeks 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 Pharmaceutical Co-Vigilance – 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

Risk Assessment

Risk Assessment analyzes corporate risk factors in various ways and presents the risks to management in a clear and actionable manner. In addition, these factors must be revised at different points in the development and operations process. Companies must stay appraised of risk mitigation history.

Regulatory Inspection

Manufacturers in the Life Science industry are responsible for upholding federal and local regulations that are set by the respective Ministry of Health. A manufacturer may also be subject to inspection by customers and other companies.

Supplier Management

Life Science companies must manage their suppliers through initial evaluation, implementation of supplier performance measures, and ongoing supervision. In addition to quality issues, these procedures help companies to identify and maintain relationships with the best suppliers.

Deviation and Corrective/Preventive Action (CAPA)

Deviations and CAPAs must be identified, organized around a course of action, and verified. It is essential that deviations and CAPAs have an effective reporting mechanism, complete with schedules, histories, and cost factors.

Change Control

Change control is the result of a customer, supplier, or internal request. A change control procedure will provide a description of the change and deal with the projects, methods, and documentation that must be altered.

Corporate Trend Analysis

Corporate trend analysis is a necessary function for virtually any company. Management must be able to use historical events to evaluate the direction and success of the operation. The analysis tracks deviations in costs, performance, and other factors.