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  • Tye Spillum CDMO Quality Agreements: Reviewing the purpose of the Quality Agreement and looking at what degree the customer will be integrated into the manufacturing process from a Quality perspective. Communication, roles, responsibilities, requirements, expectations, level of control, and the decision making process are a few of the key areas. read more
     March 7,2013 by Tye Spillum   0


  • Anthony Chambers Sustain Your ELN – Before You Start Your ELN: Change management can be found as a bullet under “critical success factors” in many Electronic Lab Notebook project charters. Touted as crucial in determining the success of an ELN, many agree in principle that change management is needed, but don’t know how to go about making it effective, tangible, and measurable. read more
     January 25,2012 by Anthony Chambers   0


  • John Trigg Management Buy-in and User Acceptance in an ELN Project: But the management commitment is also required throughout the implementation phases. Getting the balance right between hands-off and hands-on is critical; too much hands-off, and the project team and users get concerned whether management cares; too much hands-on and it can feel like interference and a lack of trust. read more
     September 12,2011 by John Trigg   0


  • John Trigg Where Do the Ideas Come From?: When it comes to purchasing and implementing laboratory systems’ software, return on investment is inevitably one of the key drivers. The up-front requirements to justify the expenditure are usually aligned to process improvement and productivity often driven by a functional need to work with dispersed teams, across different sites, regions and time zones. But there’s usually a secondary, softer requirement aligned to return on investment, but more difficult to quantify, that alludes to an improvement in knowledge management within the organisation by making laboratory information explicit, accessible and reusable. read more
     June 7,2011 by John Trigg   0



  • Mollie Shields-Uehling Nobody Knows You’re a Dog: A few years ago, The New Yorker magazine published a cartoon of two dogs sitting in front of a computer monitor. One was explaining to the other: “On the Internet, nobody knows you’re a dog.” Given the regulated nature of the global biopharmaceutical industry, the explosion in global collaboration, and our reliance on the Internet, it is absolutely essential that we know and trust the identity of people on the other side of the screen. read more
     July 13,2011 by Mollie Shields-Uehling   0


  • Jon Wetzel OpEx for 2013 – Crystal Ball Predictions: To look forward we need to first look back. From 2008-2012 we saw big pharma collide creating larger companies. Genentech-Roche, Novartis-Alcon, Pfizer-Wyeth and GlaxoSmithKline-Human Genome Sciences just to name a few. During this same time frame the economies of the world have seen crashes and upheavals causing some of these same companies to “trim” their workforces. What does all this mean for 2013? read more
     March 8,2013 by Jon Wetzel   1



  • Jon Wetzel Chunk it or Choke on it!: We’ve finished the future state map on how to fix the entire system but it’s going to take us at least a year, involve a ton of man hours and cost a lot of money. It also involves every department and it’s going to triple our daily work load until we get all the bugs worked out.” Have you heard this before? Did the idea flash and then fizzle? Next time….Chunk it! read more
     October 18,2012 by Jon Wetzel   0


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