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Life Sciences Cloud Blog
by David Blewitt 25 years have passed since the Good Automated Manufacturing Practice (GAMP®) forum was founded to deal with the evolving regulatory expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. GAMP published its first guidance in 1994.   Over the years, GAMP® has become the defacto approach to dealing with these expectations, and has morphed into leveraging a “Risk Based Approach” to tackling the nuances of computer systems qualification and validation. It has been 9 years since the last version of the guide – GAMP® 5 was published. With the avalanche of companies moving…
by Manu Vohra Life Sciences companies are focused on drug development and manufacturing that traditionally have long, multi-year R&D cycles. While this is business as usual for Biopharmaceuticals, other industries are jumping forward by leaps and bounds by leveraging Digital Transformation principals and modern tools such as real-time analytics, IoT, bleeding edge computing, and Artificial Intelligence (AI) processing. So, how do Life Sciences companies hop on the Dx ‘band wagon’? It all starts with a cloud content management layer like Box.com. Biopharmaceuticals generate copious amounts of content across their organizations, ranging from R&D to Manufacturing to…
Notes from a Lonely Life Sciences Digital Transformation Junkie (A.K.A Bryan Coddington) Digital Transformation isn’t about meeting your goals; it’s about blasting through them and reinventing your business. To do that, you often need to throw out the book and find solutions that are new, bold, and even disruptive to your team. As a medical device company, those solutions aren’t just about the latest and greatest technology but ones that also meet the rigor and requirements of the quality organization. We all know moving to the cloud is a big part of going digital but in…
Notes from a Lonely Life Sciences Digital Transformation Junkie (A.K.A Bryan Coddington) Salesforce is an amazing platform that has remained one of the most innovative and disruptive technologies since its inception in 1999. Along with CRM, customers are finding new ways to extend the platform throughout their organizations to take advantage of its powerful feature-set, such as collaboration, workflow, mobile, and reporting – to name a few. Using Salesforce for GxP applications is a relatively new and exciting area for Life Sciences professionals. For compliance reasons, users tend to be more cautious because they are relying…
Salesforce.com patches are pushed directly to the production environment, unlike releases. You get informed of what they are and what they affect. The patches have already been tested to make sure they don’t affect specific configurations. Typically, they do not affect anything internal from your own configurations as well. But, it is best to analyze the patch and determine whether to regression test it. Patches can be regression tested very quickly, especially if you have an automated tester. For most patches, it is possible to determine using your change control processes that they have no effect on anything preexisting. USDM…
Vendor Qualification is going to depend on your own requirements. You need to establish that the vendor meets the requirements of your Service-Level Agreement (SLA). What goes in the SLA is important and it needs to have an appropriate level of documentation, processes, and experience around infrastructure. Good qualification, data centers, and security procedures need to be formally documented and approved. Verify that there are redundancies in place such as correct document management systems, disaster recovery systems, and back-up systems. Vendor Qualification can be viewed in two ways. You can either preform vendor audits to specify that you need these…
USDM Life Sciences is not suggesting not to validate any of your low-risk requirements. The important aspect to remember is if your implementation processes are documented, sound, repeatable, and your vendor has evidence of all the testing that they've done, you may not need to test out of the box functionality items that are considered to be low risk. If you have items that are not GxP or low-risk GxP, depending on its complexity and configuration, you may have some informal user acceptance testing. You can leverage your supplier’s testing to have confidence in certain areas of the system’s functionality.…
The USDM Validation Accelerator Pack (VAP) takes care of the core platform. Beyond that, specific configuration and customization will be related to your company and your own use cases and requirements. By creating new scripts as necessary or modifying existing ones, those requirements are added to the preexisting requirements in the VAP. Although it is not possible to anticipate a specific company’s requirements in a VAP, we do qualify that platform and add in the necessary pieces. The USDM Life Sciences Cloud Assurance Validation Accelerator provides the components required to meet FDA regulatory requirements including 21 CFR Part 11. For…
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