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Samples in periodicals archive:
Good documentation practices (GDPs) often indicate a low risk supplier.
Chapter 4 summarizes the requirements of GMP-related documentation activities, listing the various types of expected records and the corresponding retention periods, defining the processes for generating and controlling GMP documents, and reminding of the basic principles of Good Documentation Practices.
It is to this end that JAPM supported by SABEQ Program organized the Good Documentation Practices and Batch Record Review workshop to the Pharmaceutical Industry.
Utilizing the ClinTest(TM) suite of cutting edge automated validation tools, Users will be able to dramatically shorten their Software Development Life Cycle on Web based or IVR system deliverables; allowing our User's system(s) to be released into production faster, complete with automatically generated Objective Evidence that adheres to all applicable Good Clinical Practices and Good Documentation Practices.
This 68-page manual explains the principles or good documentation practices, provides step-by-step instructions for many documentation-related processes and provides numerous examples and templates that can be modified for use by industry companies.
Baseline principles like Good Manufacturing Practice (cGMP), Good Documentation Practices (GDP), Risk Assessments per ISO 14971, chain of custody processing, and software/process validations which are now so familiar to the medical industry through enforcement actions by the FDA are still not being sufficiently cultivated within the BioTech sector," says Marshall Wenrich, Realtime Group President.
As director of corporate compliance, Keller played an integral role in creating, communicating, and training corporate-wide standardization processes including controlled documents management, internal and external audits, good documentation practices, non-conformance processing and management, do not call compliance, and corrective and preventive measures.