Pharmaceutical Document Management Control System

MasterControl's Pharmaceutical Document Control Software Ensures Compliance with GMP/GCP and 21 CFR Part 11, Part 50, Part 56, Part 210-211, and Part 312 Requirements

The concept of a pharmaceutical document management is closely intertwined with quality control, an integral principle found in the current Good Manufacturing Practice (cGMP) regulations that apply to the pharmaceutical industry. The guidelines in 21 CFR Parts 210 and 211 require the establishment of a quality control unit responsible for approving or rejecting all procedures and specifications that affect the quality of a drug product. Specifically, 21 CFR 211.22 provides that the responsibilities and procedures applicable to the quality control unit shall be in writing. Additionally, it stipulates that these procedures must be followed. Within such a quality system, written procedures must be followed and deviations from them need to be justified and documented.

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