ValiCor Associates, Inc.

ValiCor Associates, Inc. provides contract validation and regulatory compliance services to the Pharmaceutical, Medical Device, and Biotechnology industries. These industries are regulated by the US Food and Drug Administration. Authority to regulate these industries is given to FDA based on the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)), and codified in the Code of Federal Regulations.

Since the documents prepared by ValiCor are used in the validation and ongoing operation of GMP regulated facilities, ValiCor feels the need to have a Quality unit.

A quality unit is any person or an organizational element designated by the firm to be responsible for the duties related to quality control [21 CFR 210.3(b)(15)]. The quality control unit has responsibility and authority for certain actions [21 CFR 211.22], including reviewing and approving or rejecting written documents and records.