Glossary Terms (Simple List)
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Data Lake
A storage repository that holds, in a structured way, a vast amount of raw data, including metadata, in its native format until it is needed. (TR84)
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Data Lifecycle (MHRA)
All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive/retrieval and destruction.(TR80) (TR84)
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Data Lifecycle (WHO)
All phases of the process by which data is created, processed, reviewed, analyzed and reported, transferred, stored and retrieved and monitored until retirement or disposal. There should be a planned approach to assessing, monitoring and managing the data and the risks to those data in a manner commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the data life cycle. (TR80)(TR84)
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Data Process Flow Map
A flow map that uses a baseline process flow map and overlays the data flow. (TR84)
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Data Vulnerability
An indicator of data’s level of exposure to data integrity failures due to intrinsic weaknesses in manufacturing processes, data-capture technology, and human factors or a combination thereof.(TR84) -
Date of Manufacture
For small molecules, the date of manufacture of a drug product is considered to be the initial date that an active ingredient has been added during manufacturing. For biologics the date of manufacture can be determined in multiple ways and should be consistent with internal quality systems and the product license application. (TR53)
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De Novo Sequence Assembly
Assembly of short reads of a sequence to generate a contiguous sequence (contig). (TR71)
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Dead Leg
Area of entrapment in a vessel or piping run that could lead to contamination of the product. (TR69)
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Deadlegs
An area of entrapment in the vessel or piping run that could lead to contamination of the product due to insufficient exposure to moist heat. (TR61)
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Decision Maker(s)
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)