4.1. Document Control and Record Management
Document Control: Process for the creation, control and revision of controlled documents and the associated requirements for review, approval, final release, distribution and archiving.
Control of Records/Records Management: Process that defines the minimum requirements for the identification, storage, security and integrity, retrieval, retention time and disposition of Quality Records necessary to demonstrate compliance with corporate, federal and international requirements and regulations and for effective operation of Quality Management System.
Training for the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner.
eQMS, or electronic Quality Management System, is a software that helps maintain and manage Quality Management System.
Process for identifying gaps in the existing procedures and processes due to changes or updates in external documents such as standards and guidance documents to ensure compliance.
Process for establishing competence, providing needed training and ensuring personnel awareness to the Quality Management System and work affecting product quality.