I most recently was the lead Project Manager for the implementation of a Change Management module for the QA group of one of our pharmaceutical clients. This new application was an add-on to the existing suite of Quality Management System (QMS) modules, as part of a pre-approval inspection (PAI) readiness initiative.
Posts Tagged ‘Software as a Service’
At Maxiom Group, many of our client companies are making the transition from drug development to commercial operations. Among other things, this often involves significant growth and change in the IT group. What could once be managed on a very informal basis must now become well defined and disciplined IT processes. IT managers in this situation often experience great difficulty in creating these new and formal processes essentially from scratch. We also find that this is as true for the SaaS or hosted services as it is for the traditional on-premises environments.
In many facets of life, if you want to do something right, you feel inclined to do it yourself. This age old adage is no different for the biopharma industry, especially when it comes to developing home grown clinical software solutions. But now many biopharma companies actually employ an extensive software development team, not to mention enough IT resources and infrastructure to host and maintain the system? And with tighter resources available, is this really where a company’s talent and energy should be focused?
Commercial launch of a biopharma company’s first drug product is a transformative event. A first product launch includes not only preparing the organization for the transition from development to commercial, but also transforming the IT applications and support model for the company. IT organizations that have been trying to differentiate themselves or increase business presence have a unique opportunity to:
1. Modify current IT practices
2. Pre-plan for commercial needs
3. Support other departments, e.g. G&A, prepare for corporate transition
About a year ago, I wrote a blog post about using an ERP system to manage the Clinical Supply Chain. Since that time I’ve had many healthy debates with different people about the pros and cons of this versus other applications that were designed specifically towards clinical operations. While I am not an expert on clinical specific apps, I do consider myself knowledgeable about ERP and how it manages supply chain transactions and data. I see far more similarities than differences between the commercial and clinical supply chain, but let’s put all the theory aside for a moment and look at a real life example.
At Maxiom Group we do a lot of ERP selections with our clients in the life sciences industry. Frequently these clients are concerned about specific features and capabilities, and it’s true that sometimes these details can solve, or cause, big problems. However, with ERP systems we’ve found it’s really the big picture that matters. Following are a few of the “big picture areas” we focus on when selecting and ERP system with our clients.
Is the Biopharma Enterprise Document Management market shifting? Sharepoint 2010 may now be a practical contender!Tuesday, October 12th, 2010
As you may have heard, Microsoft has released SharePoint 2010. This release has been touted to have extended features, such as enhanced governance, a more intuitive user interface and better support of the management and discovery of content.
Many Biotech and Pharma companies at various stages of maturity struggle with an accurate tracking mechanism for managing all of their samples. Similar to commercial and clinical inventory (management / tracking / visibility), SAMPLE VISIBILITY is also a significant issue for Life Science companies! There are several considerations, for example:
• Legal: e.g. when a patient withdraws from a study and wants their specimens withdrawn and/or destroyed.
• Regulatory: such as how long samples are to be kept in storage.
• Logistics: packaging, labeling, and shipping conditions.
• Cost: such as absorbing expensive long term storage.
Since we do a lot of pedigree-related work, and deal with many of the vendors in this space, we had an opportunity to get an early look at Oracle’s Pedigree and Serialization Manager (OPSM) solution. OPSM was designed to create and manage serial numbers, record and transmit serial number hierarchies and create pedigrees. OPSM was designed to comply with both document model (California) and centralized server (European) methods of pedigree reporting and to be extensible to meet future pedigree formats and data standards. Additionally, OPSM has an open web services architecture that should allow for additional features, such as product authentication, analytics and enhanced supply chain visibility.
More than half of U.S. enterprises now consider cloud computing a viable technology, with favorable views on cloud jumping by more than 50 percent in just a year, according to the Boston market research firm Yankee Group. The information technology-oriented research house said in a report that “cloud computing is on the cusp of broad enterprise adoption.”