Regulatory agencies system

Establish Verification Procedures. Verification can be performed independently by the manufacturer and the regulatory agency to determine that the HACCP system within the plant is in compliance with the HACCP plan as designed. [Pg.33]

NPDES Permit National Pollutant Discharge Elimination System permit is the regulatory agency document issued by either a federal or state agency which is... [Pg.619]

A system for reporting emergencies to the proper regulatory agencies... [Pg.89]

Laboratory notebooks—It may be debatable to consider laboratory notebooks as text documents, but they should be mentioned here because of their importance in preclinical development. Laboratory notebooks are used to record experimental procedures, observations, raw data, and other important information. Although laboratory notebooks are rarely used for submission to regulatory agencies directly, they are available for inspection by the authorities in the Preapproval Inspection (PAI) and other GMP/GLP-related inspections. Currently, most of the major pharmaceutical companies still use paper-based laboratory notebooks. Electronic-based notebook systems are being developed and commercialized, which are discussed in Chapter 9. [Pg.63]

Does the application or system employ electronic signature capabilities and/or provide the sole record of the signature on a document subject to review by a regulatory agency ... [Pg.1060]

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