Salesforce 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.
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. USDM is committed to helping you to successfully and compliantly move to the cloud, optimize your processes, and digitally transform your businesses. Here are five tips that lead to success when using Salesforce for GxP.
Key takeaways
- Qualify first. Treat Salesforce as a GxP platform with a documented qualification baseline before you build a single regulated workflow.
- Plan for three releases a year. Salesforce ships in spring, summer, and winter on a fixed schedule — evaluate each release for GxP risk and keep documentation current.
- Optimize before you migrate. Don't lift-and-shift an old process; use the move as the moment to redesign it.
- Start with one or two processes. Prove value on a focused use case, validate it, then scale.
- Govern centrally. A dedicated Salesforce GxP governance team keeps a shared platform compliant as adoption spreads.
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.
Platform qualification is also where your 21 CFR Part 11 obligations get pinned down — electronic records, electronic signatures, and audit trails all need to be demonstrably under control. A risk-based computer software assurance (CSA) approach lets you focus testing effort where patient safety and product quality are actually at stake, rather than documenting everything to the same exhaustive depth.
Don't skip the audit trail. The qualification baseline you establish on day one is what every future Salesforce release, configuration change, and new GxP app inherits. Get it right early and the rest of your program compounds; cut corners and you'll re-litigate the same questions on every change.
2. Have a process for the three 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.
Three vendor-pushed releases a year is not a problem to dread — it's a cadence to operationalize. Treat each release like a planned change-control event, not a fire drill.
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.
Redesigning the process is also the right time to think about how data moves. As you consolidate workflows onto one platform, data integrity across objects, integrations, and reports becomes a first-class design requirement — not an afterthought you bolt on later.
4. Start with one or two 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.
A simple sequence for your first GxP workflows
- Pick a focused use case. One or two high-priority processes — QMS, document control, product registration, or site evaluation — not the whole portfolio.
- Design for the future state. Optimize the process; don't replicate the old one.
- Build, test, and validate. Apply a risk-based assurance approach so testing matches GxP impact.
- Demonstrate value, then expand. Use the proven workflow as a template to add the next process quickly.
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.
A centralized team is also where ongoing continuous compliance lives day to day — owning the release cadence, the validation backlog, and the shared-object hygiene that keeps a growing platform from drifting out of a qualified state.
With USDM’s Cloud Assurance, life sciences organizations can rest assured that the Salesforce platform is qualified and stays continuously compliant. 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.
FAQ: Salesforce and GxP compliance
Who is responsible for compliance on the Salesforce platform?
Responsibility is shared. Salesforce, as the cloud vendor, owns elements such as change control, audit history, and software development SOPs. As the customer, you are responsible for obtaining proof of those procedures — sometimes through an onsite audit — and for testing and documenting the core platform features you rely on, including security, permissions, object and field configuration, and audit history tracking.
How do Salesforce's three releases a year affect GxP validation?
Salesforce pushes new versions in the spring, summer, and winter on a fixed, non-voluntary schedule. Most changes aren't GxP-relevant, but some are. The practical approach is to pull the release notes early, evaluate each change for GxP risk, and test and document accordingly. Documentation that lags behind the current release can put you out of compliance if a GxP element hasn't been proven to work as expected.
Should we migrate our existing process into Salesforce as-is?
It's tempting, but moving to a new platform is the ideal moment to optimize. Many processes were designed years ago for a different business reality. Use the migration to redesign — taking advantage of additional workflow, collaboration, mobile, and real-time reporting capabilities — rather than freezing an outdated process in new technology.
Where should a life sciences organization start with Salesforce GxP?
Start small. Focus on one or two high-priority processes such as QMS, document control, product registration (medical device), or site evaluation (clinical). Build and validate those first, demonstrate value and ROI, then use them as a template to add more processes quickly.
Why do we need a centralized governance team?
As adoption spreads, more teams share the same system and the same objects and workflows. A centralized “Center of Salesforce GxP Excellence” prevents duplicated effort, broken configurations, and stalled draft-state apps. It establishes SOPs and maintenance schedules and maintains a roadmap for bringing on new processes and users.
Ready to run Salesforce as a qualified GxP platform? USDM can qualify your platform, validate your first GxP workflows, and keep you continuously compliant across every Salesforce release. Contact us to talk through your roadmap, or explore USDM Cloud Assurance to see how qualification and ongoing compliance work together.
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. We focus on regulated industries and have 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.