Examples of metadata might include a user name, date, and time.It also permits data to be attributable to an individual.Typically, these are data that describe the structure, data elements, interrelationships, and other characteristics of data.Metadata is data that describes the attributes of other data and provides context and meaning.An approved set of instructions, which can be replicated to issue controlled operational copies.A document, which gives general or specific instruction on how to perform certain activities (i.e.A systematic procedure of preparing, reviewing, approving, issuing, recording, storing, and archival of documents associated with GxP activities.A combination of text, graphics, data, audio, pictorial or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.A reliable (written) record that can be used at a future time to clearly and completely recreate an activity, event, or process.A record that describes how an activity, event, or process was actually performed.All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation and migration), use, data retention, archive/retrieval, and destruction.The extent to which all data are complete, consistent, and accurate throughout the data lifecycle.Data Integrity: (Related: SOP for Handling of Data Integrity Observations).The total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained, and used to ensure a complete, consistent and accurate record throughout the data lifecycle.The signature of the person responsible for providing official permission or approval to another individual to perform a particular task.CC No: Change Control Number ( SOP for Change Control Management). QA head/ designee shall be responsible for Managing investigations and impact assessments for deviations/incidents concerning Good Documentation Practices / GDP procedures.QA shall be responsible for implementing and managing a master signature log of all department personnel, including contract and temporary personnel.Quality head/designee shall be responsible for implementing and maintaining procedures to provide requirements for good documentation practices.SOP for Recording of Specimen Signatures of Employees.This standard applies to cGxP documents (electronic and handwritten) used in the manufacturing, packaging, labeling, testing, storage, and distribution of Drug Products.This Standard Operating Procedure (SOP) defines the requirements for the compliant, consistent, and accurate completion of Good Documentation Practices.Guideline for Good Documentation Practices 1.0 PURPOSE: Standard Operating Procedure (SOP) cum Guideline for Good Documentation Practices for cGxP documents (Electronic and Handwritten) Pharmaceutical Drug Manufacturing Plants.
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