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 on someone outside of their organization to provide and maintain elements of the application. We are committed to helping people successfully and compliantly move to the cloud, optimize their processes, and digitally transform their businesses. Here are 5 tips I’ve found lead to success when using Salesforce for GxP:
1. Qualify the platform: Salesforce, as a cloud vendor, is responsible for various compliance elements such as change control, audit history, and software development SOPs. As a customer, you are responsible for obtaining proof of these procedures. Depending on your own compliance requirements, this may require an onsite audit. You are also required to test and document the core features of the Salesforce platform such as security, permissions, object/field configuration, audit history tracking, and many others. Sound daunting? It can be if you haven’t done it before. The good news is that if it’s done correctly, the Salesforce platform qualification creates a baseline for incredibly powerful, user-friendly GxP applications that are available to purchase or can be created to your exact requirements.
2. Have a process for the 3-releases per year: Every year Salesforce releases new versions in the spring, summer, and winter. Along with these releases come enhancements, fixes, and new features that make the system better than before. These releases are not voluntary and are pushed out on a schedule (check it out here: //trust.salesforce.com). The majority of changes are not GxP, but some are, and require testing and documentation. To best prepare for these releases, you can obtain the release notes as soon as they come out, evaluate each change to determine GxP risk, and then test and document accordingly. Having documentation that is not up to date with the latest Salesforce release will take you out of compliance if there’s a GxP element that YOU haven’t proven to work as expected.
3. Don’t just put your existing process in Salesforce: Taking your as-is process and moving it over to Salesforce without changing anything is easy, but it’s not the best way to go. The fact that you’re selecting a new technology and platform makes it the perfect time to update and optimize your process. Perhaps your process was developed 5-10 years ago, or even a few years ago, and at the time was the best way to do things. Now your business has changed, new guidelines are being enforced, new people and skill sets have entered your organization, and the Salesforce platform has tool and capabilities that you haven’t had access to. Make sure to take the time to identify areas that need improving or can take advantage of additional workflow, collaboration, mobile, and real-time reporting.
4. Start with 1 or 2 GxP processes at a time: Salesforce is powerful and flexible enough to do almost anything or integrate with any other system. The key is to focus on 1 or 2 high priority items such as QMS, doc control, or even just pieces of these larger applications. Configuration of Salesforce can happen quickly but really developing the solution, having the right user-interface development, possible integrations, and training, takes time. Don’t try to do it all at once. For medical device, perhaps start with a product registration process. For clinical, perhaps optimizing sites evaluation. Once you have built and validated a few processes, you can quickly add more and with that, add incredible value and ROI to your organization.
5. Have a centralized governance team for all things Salesforce GxP: The fun thing about Salesforce is once you get those first few apps released, word is going to spread and more users are going to want it for their teams. Because it’s GxP, more rigor is required to properly document requirements, test the end-use, and approve the final product. These can pile up and remain in a “draft-state” if there’s not a team dedicated to their completion. Also with Salesforce, more and more teams and processes are going to be in the same system. This lends itself to sharing common objects and workflow, which requires a team with awareness and visibility to the entire system. Otherwise, you have multiple groups in there duplicating efforts or worse, breaking things or erroneously changing settings that negatively affect other users. Right from the get-go, this governing body or “Center of Salesforce GxP Excellence,” can establish SOPs and maintenance schedules, and create a living, breathing roadmap to bring on new processes and users.
With USDM’s Cloud Assurance, life science organizations can rest assured that the Salesforce platform is qualified and stays continuously compliant. USDM’s Cloud Assurance aligns with Salesforce releases and qualifies those releases before they are deployed. Once on a qualified platform, USDM can build and launch a variety of GxP workflows or applications. To learn more or schedule a demo, contact us at firstname.lastname@example.org
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About the Author
Bryan Coddington is the Vice President of Cloud Technology at USDM Life Sciences. For almost a decade, Bryan has been a senior executive in the Cloud space with in-depth knowledge of sales, marketing, and service and support processes and best practices, helping companies maximize their investment in cloud-based CRM applications.
About USDM Life Sciences
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.