Information Technology

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Boutique vulnerabilities (BioPhorum cyber security education series: one)

The BioPhorum IT Cyber Security Education Series: 1 This is the first in an ongoing series of publications to be delivered by the BioPhorum IT Cyber Workstream as part of the new BioPhorum IT Cyber Security Education Series– a portfolio of articles and short papers addressing emerging issues in cyber security in the biopharmaceutical manufacturing environment. Focusing on key findings from extensive surveys, case studies and peer reviews, the...

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Is your digital manufacturing plant cyber resilient?

As the maturity of digital manufacturing plants grows, so does the risk of a cybersecurity or other digital incident. A successful phishing attack or a data center cooling failure, as examples, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer. So the ability of a plant to minimize the risk of a digital disaster, and quickly restore operations if one occurs, is a vital...

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Sponsor / CMO Data Standards

The use of CMOs for clinical and commercial biopharma production is widespread and significant.  More that 50% of global drug product capacity is with CMOs and the story is not much different in drug substance. Add to this the diversity of CMOs and the contacting out of available capacity and the number and complexity of relationships is staggering.  Yet there are no effective data standards meaning all too often sponsors are dependant on...

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Logistics service provider integration webinar

Listen to this exclusive webinar, presented by Donatien Menu, Martin Bashford, Vanya Semkova and Jonathan Dakin, authors of a recent paper – the Logistics Service Provider (LSP) Integration paper. The webinar brings you commentary from the authors about the key features, benefits and opportunities for developing industry solutions in this field.

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Logistics collaboration hub: An opportunity for significant time and cost savings

Most biopharmaceutical manufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services, and they are usually linked using customized, electronic, point-to-point connections. But this model can have major time and cost challenges when creating these connections. Updating or changing the links may also be expensive and the effort needed may hamper a company’s ability to quickly respond...

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Logistic service provider (LSP) integration

Many biomanufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services. Typically linked using customized, electronic, point-to-point connections. These connections can be expensive and slow to set-up and expensive to update in response to changing market demands. There is no dominant technical solution that monitors the condition and location of shipments, and that enables companies to adopt different solutions for different regions and partners. There is a need to raise the awareness of software vendors of this unmet need and the real interest of many industry stakeholders if a suitable LSP integration solution was available.

This paper provides an overview of the current needs of manufacturers and their technical integration with their network of LSPs. It contains a high-level requirements specification for a common, cloud-based, integration platform, that would reduce customization and multiple point-to-point solutions. The specification is designed to help technology companies develop this services. Informal benchmarking across member companies indicates that ‘collaboration hub’ use would deliver a 50–70% saving in time and cost when linking to a new partner. These benefits would be realized by both partners making the new connection.

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The ‘how to’ guide to implementing Agile in GxP

The ‘how to’ guide to implementing Agile in GxP The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received. It described how the use of Agile in a GxP environment was limited due to perceived regulatory risks. The Guidance provides an approach that ensures delivery of software solutions while at the same time maintaining regulatory compliance. It also details the approach and key prerequisites...

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Agile GxP: Guidance on the use of agile in a GxP environment: Companion document

This Companion document, to be used alongside its original guidance ‘Guidance on the use of Agile in a GxP environment’. It provides more practical advice on how to implement agile in a GxP environment. The Companion is less about ‘what is Agile’ but more ‘how to do it’ in the biopharmaceutical arena. The Companion details five levels to full Agile working that will help companies determine what level they are currently at and what they need to do to progress to the next stage. This approach will help companies understand how to implement Agile in GxP environments more rapidly and effectively.

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