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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Pharma-production.jpg|160px]]</div>
<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig1 Scroggie DigDisc2023 2.gif|240px]]</div>
'''[[Good Automated Manufacturing Practice]]''' ('''GAMP''') is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff.
'''"[[Journal:GitHub as an open electronic laboratory notebook for real-time sharing of knowledge and collaboration|GitHub as an open electronic laboratory notebook for real-time sharing of knowledge and collaboration]]"'''


GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
[[Electronic laboratory notebook]]s (ELNs) have expanded the utility of the paper [[laboratory notebook]] beyond that of a simple record keeping tool. Open ELNs offer additional benefits to the scientific community, including increased transparency, reproducibility, and [[Data integrity|integrity]]. A key element underpinning these benefits is facile and expedient knowledge sharing which aids communication and collaboration. In previous projects, we have used [[LabTrove]] and [[LabArchives, LLC|LabArchives]] as open ELNs, in partnership with GitHub (an open-source web-based platform originally developed for collaborative coding) for communication and discussion. Here we present our personal experiences using GitHub as the central platform for many aspects of the scientific process ... ('''[[Journal:GitHub as an open electronic laboratory notebook for real-time sharing of knowledge and collaboration|Full article...]]''')<br />
 
''Recently featured'':
"It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system." ('''[[Good Automated Manufacturing Practice|Full article...]]''')<br />
{{flowlist |
<br />
* [[Journal:SODAR: Managing multiomics study data and metadata|SODAR: Managing multiomics study data and metadata]]
''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]]
* [[Journal:Benefits of information technology in healthcare: Artificial intelligence, internet of things, and personal health records|Benefits of information technology in healthcare: Artificial intelligence, internet of things, and personal health records]]
* [[Journal:A quality assurance discrimination tool for the evaluation of satellite laboratory practice excellence in the context of European regulatory meat inspection for Trichinella spp.|A quality assurance discrimination tool for the evaluation of satellite laboratory practice excellence in the context of European regulatory meat inspection for ''Trichinella spp.'']]
}}

Revision as of 16:20, 26 March 2024

Fig1 Scroggie DigDisc2023 2.gif

"GitHub as an open electronic laboratory notebook for real-time sharing of knowledge and collaboration"

Electronic laboratory notebooks (ELNs) have expanded the utility of the paper laboratory notebook beyond that of a simple record keeping tool. Open ELNs offer additional benefits to the scientific community, including increased transparency, reproducibility, and integrity. A key element underpinning these benefits is facile and expedient knowledge sharing which aids communication and collaboration. In previous projects, we have used LabTrove and LabArchives as open ELNs, in partnership with GitHub (an open-source web-based platform originally developed for collaborative coding) for communication and discussion. Here we present our personal experiences using GitHub as the central platform for many aspects of the scientific process ... (Full article...)
Recently featured: