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GMP Documentation - Documents, Records and Data Integrity

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GMP Documentation - Documents, Records, Data Integrity and their definition and Classification

GMP Documentation - Documents, Records and Data Integrity

GMP Documentation

                             All GMP (Good Manufacturing Practices) documents shall be accurate, truthful and complete, readily retrievable and traceable. All entries shall be concise, legible, unambiguous and accurate.

Document

                    A document is a digital (Computer generated means which we cannot touch say Soft Copy) or physical (which we can touch say Hard Copy) representation of a body of information designed with the capacity to communicate with peoples (persons which take information from these documents). A document may clear symbolic, pictorial or sensory-representational information.

Instruction Document

                              A document which gives general or specific instruction on how to perform certain activities.

Master Document

                          An approved set of instructions which can be replicated to issue controlled operational copies.

Record

              Any document which contains recorded evidence of an activity done during manufacturing, testing and release of a product. The records could be hand written or electronically generated.

Raw Data

                Any worksheets, memorandum, notes, or exact copies thereof, which are the result of original observations and activities. This also includes photographs, microfilm or microfiche copies, computer printouts, magnetic media and recorded data from automated instruments.

Electronic Record

                             A combination of text, graphics, data, audio, pictorial or other information represented in digital form that are created, modified, maintained, archived, retrieved or distributed by a computer system.

Data Integrity

                         The representational faithfulness of information to the true state of the object that the information represents, where representational faithfulness is composed of three essential qualities or core attributes: accuracy, truthfulness and completeness.



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