Executive takeaways
- Classification drives sequencing: separating critical from non-critical GxP applications tells you what to migrate first and how much validation rigor each workload needs.
- Critical GxP applications touch the product or patient safety: they impact physical product properties, measure or disposition the product, or automate quality and safety surveillance.
- Strategy beats speed: a clear end-to-end migration plan, early stakeholder alignment, and supplier qualification prevent data loss, downtime, and excessive validation.
- Phased migration de-risks the journey: moving complex, high-impact GxP applications in stages preserves business continuity while controlling access to sensitive data.
Tips for maintaining quality during transitions
Cloud migrations can be complex and risky. After the COVID-19 pandemic mandated remote working, employers had to rethink workflows and implement new cloud-based solutions. Within the last two years, digital transformation has become a key driver in staying competitive within the global marketplace. The life sciences industry has traditionally been a laggard in adopting new technologies and cloud-based solutions; however, it has now become critical to consider migrating some or all processes to the cloud. McKinsey’s research reports that leading life-sciences companies are discovering the potency of the cloud in enabling analytics, shrinking innovation cycles, and standardizing processes across global operations, among other benefits.
Starting with a clear strategy will lay a strong foundation for your migration process. An end-to-end migration plan is necessary to adopt and implement cloud technologies. Begin by assessing current infrastructure and applications to determine which of your workloads can move to the cloud. It is also important to note that each application moved from an on-premises database to the cloud may have different migration requirements.
Once a plan is in place, all stakeholders must be aware of the objectives and expectations of the cloud migration. Otherwise, your organization can risk losing data, disrupting operations, and incurring high costs.
What makes a GxP application critical?
When migrating to the cloud, an important consideration is determining which applications will move first, which requires an analysis of critical vs. non-critical applications within your company. In general, a critical application is any application that is essential for business continuity.
Within the life sciences industry, critical GxP applications have at least one of the following key attributes:
- They impact the physical properties of the product or essential process
- They measure, inspect, analyze, or disposition the product process
- They automate surveillance, trending, and tracking of product quality and safety issues
Examples of critical GxP applications include:
- Expiration labeling applications
- Batch record systems
- Some elements of enterprise resource planning (ERP) systems
- Clinical systems
On the other hand, non-critical GxP applications do not have any characteristics of a critical application. The non-critical GxP applications exist to manage those systems ancillary to them. They do not touch the product or directly impact patient safety.
A critical GxP application is any application that touches the product or directly impacts patient safety. Everything else is a candidate for lighter, risk-proportionate validation.
Common cloud migration challenges
Once your company clearly understands which applications require the most immediate attention, you can begin shifting workloads to the cloud. Many questions will arise along the way, and businesses of all sizes need assistance making their cloud journeys.
Here are some of the significant challenges that organizations face when they transition to the cloud:
- Failure to adequately evaluate the cloud technology vendor
- Failure to identify any required data migration or archival needs
- Not involving business owners early on in the process
- Not leveraging supplier testing activities which results in excessive validation
To combat these common challenges, here are some critical steps you can take before beginning your cloud migration journey:
- Ensure supplier qualifications are adequate for software suppliers, including SDLC review, text review, and change control review
- Identify all archival needs early on
- Involve all business owners early in the process for configuration and role needs
- Whenever possible, leverage supplier testing for OOB (out of the box) items
- Use critical thinking to minimize testing of low-risk functions
A risk-based readiness checklist before you migrate
- Inventory and classify. Catalog every application and label it critical or non-critical GxP based on product impact, measurement/disposition, and quality surveillance attributes.
- Qualify the supplier. Review the vendor's SDLC, testing, and change control so you can confidently leverage their activities under a CSA approach.
- Protect your records. Confirm migrated systems preserve audit trails, electronic signatures, and record integrity in line with 21 CFR Part 11 and sound data integrity practices.
- Sequence by criticality. Plan a phased move that starts with high-impact, complex GxP applications while controlling access to sensitive data.
- Plan for the long run. Treat validation as ongoing, not one-and-done, through validation lifecycle management that keeps systems compliant across future releases.
Why phased migration is the right starting point
It is common for life sciences companies to start their cloud journey through the phased migration of critical applications and databases to ensure a smooth transition. Phased migration helps move highly complex, GxP applications to the cloud while controlling access to sensitive data. In these situations, life sciences companies divide their migration by department, site, or content type. Phased migration is also based suited for critical GxP applications that impact your business continuity, which is why it is a great place to start if you are looking to transition to the cloud.
Because cloud workloads often introduce new suppliers and external dependencies, it is worth pairing your migration plan with disciplined third-party risk management so vendor risk is assessed and monitored alongside your own validation activities.
By starting with a strong strategy, communicating objectives to all stakeholders, determining critical GxP applications, and considering a phased migration plan, you can overcome some of the most common challenges companies face during their transitions. A smooth transition journey can mean quicker implementations with fewer validation issues and minimal to no performance downtime.
Discover practical strategies for simplifying compliance by leveraging vendor activities in our latest white paper — Validation Requirements and Responsibilities
How USDM helps you migrate with confidence
At USDM, our team of experts understands the importance of maintaining business continuity as you transition to the cloud. We are committed to working alongside you on your digital transformation journey, ensuring a smooth transition to the cloud. We work to ensure that your company can quickly and accurately get life-changing products to market faster.
Consider USDM’s Cloud Assurance services when migrating to the cloud. USDM’s cloud assurance subscription service ensures that all your vendor solutions include GxP compliance from implementation through ongoing validation maintenance, including new software releases.
Learn More
We invite you to watch our webinar, How to Maximize Your GxP Use of the Public Cloud, or read our white paper Regulated GxP Workloads in the Public Cloud to learn more about USDM’s public cloud solution.
FAQ: Critical vs. Non-Critical GxP Applications
What is a critical GxP application?
A critical GxP application is one that is essential for business continuity and has at least one key attribute: it impacts the physical properties of the product or an essential process; it measures, inspects, analyzes, or dispositions the product process; or it automates surveillance, trending, and tracking of product quality and safety issues. Examples include expiration labeling applications, batch record systems, some elements of ERP systems, and clinical systems.
How is a non-critical GxP application different?
A non-critical GxP application has none of the characteristics of a critical application. These systems are ancillary, managing supporting functions that do not touch the product or directly impact patient safety, so they typically warrant a lighter, risk-proportionate validation approach.
Why does the critical vs. non-critical distinction matter for cloud migration?
Classification determines what you migrate first and how much validation rigor each workload requires. Identifying critical GxP applications lets you focus immediate attention and the most thorough validation on the systems that affect product quality, patient safety, and business continuity.
What are the most common cloud migration challenges?
Frequent pitfalls include failing to adequately evaluate the cloud technology vendor, not identifying data migration or archival needs early, leaving business owners out of the process until late, and not leveraging supplier testing activities, which leads to excessive validation.
Why start with a phased migration?
Phased migration moves highly complex, high-impact GxP applications to the cloud in stages while controlling access to sensitive data. Companies often divide the work by department, site, or content type, which protects business continuity and reduces validation issues and downtime during the transition.
Talk to USDM about your cloud migration
We would be delighted to discuss your unique situation and help you classify your applications, sequence a risk-based migration, and keep your systems validated and compliant from day one. Contact us to schedule a call with our compliance and technology subject matter experts.