Definition: Computerized System Validation (CSV)

Computerized systems for research, development, and manufacture of drugs and other new therapies have an enormous impact on the potential safety, efficacy, and quality of health care products and services. Regulators worldwide are striving to ensure that health care industries keep these computerized systems under documented management control.

Pharmaceutical and biotech professionals are confused about "how much is enough" in computer validation work. Many firms are losing valuable time and productivity as system teams try to figure out how to proceed in validation work. A standards-based approach is needed for CSV work to become a normal part of business in regulated environments, and The Compliance Group, Inc. has different systems ready for implementation depending on your specific needs.