In certain regulated industries, such as pharmaceuticals, medical device manufacturing, and life sciences, there is more scrutiny around the data generated by training efforts. For this, SAP SuccessFactors offers a Validated Learning Management System (LMS) solution.
Getting a Validated LMS off the ground requires special implementation methodology. Typically, there are also product-based differences compared with a “normal” non-validated LMS.
Many Validated implementation processes are intrinsically customer-dependent—including increased focus on testing, documentation of results, and rigorous process around audit trail and accountability. Many life science customers have a special Quality function within the organization that is responsible for those requirements. Others will contract with a third-party to provide those services.
How Validated LMS Differs
For SAP SuccessFactors LMS—Validated SaaS, product differences from the standard Learning solution include:
- Customer gets 4 distinct LMS instances:
- Non-Validated Sandbox
- Validated Preview
- Validated Production
- Non-Validated Production Support
- Annual vs. Quarterly releases – this schedule is staggered, with new releases in Non-Validated Sandbox and Validated Preview instances in the Fall, and releases to Validated Production and Non-Validated Production Support in the Spring – allowing for a more proactive cyclical testing strategy.
- Availability of IQ (Installation Qualification) Audit Report.
- Validation Toolkit from SAP SuccessFactors, providing a helpful starting point for customers without a well-developed Quality function.
Some customers who would normally be candidates for a Validated solution opt to implement “regular” LMS instead, which in the case of SuccessFactors Learning means a quarterly release schedule versus an annual one. On the plus side, this makes new and cutting-edge features available sooner.
The primary drawback is this mandates more frequent execution of test scripts related to new features, as well as quarterly regression testing, primarily to ensure continuity of historical data. One customer I’ve worked with compares this quarterly release scenario to “painting the Brooklyn Bridge” – i.e. it needs to start all over again once completed.
The normal quarterly release model will also preclude availability of the IQ (Installation Qualification) report. While there are compelling arguments for both scenarios, the Validated, annual release schedule is much more logistically feasible for most life science customers. Ultimately, however, the state of FDA compliance lies in customer processes more than in the system itself.
Lessons Learned for Implementing Validated LMS
The fact remains if you’re in an industry that requires Validated LMS, you probably know it already. You shouldn’t let that stop you from building an effective training program for all employees.
We have worked with numerous customers to implement Validated LMS—again, specifically SAP SuccessFactors LMS—Validated SaaS as the solution. Through the course of those implementations, which are almost always longer and more complex engagements compared with a “normal” implementation, we have observed several key lessons learned which you should consider if planning a Validated LMS implementation.
Project timing is critical.
- In the case of SAP SuccessFactors LMS—Validated SaaS, there are three key constraints to consider in your project schedule:
- Availability of the latest release in Sandbox and Preview instances – this occurs in the Fall (usually October). Since this is where initial configuration and testing occurs, kick off the project no later than August to have enough runway leading up to the new release.
- Availability of the corresponding Production release, which usually occurs the following Spring (March). Realistically, you should not plan to go live sooner than April or May, especially if you have significant data migration from prior systems and/or integrations to consider.
- Patch dates. Following each release, there are additional scheduled patch releases (consult the SAP SuccessFactors Customer Community “Validated SaaS Learning Communication” Group for the latest annual schedule). Although these patch releases are primarily designed to correct defects, and do not introduce new features, most customers opt to avoid go-live immediately following a patch release.
Document configuration decisions in painstaking detail
- Don’t be afraid to customize the Configuration Workbook to ensure the level of detail appropriate for your implementation. Your Configuration Workbook will play a much more critical role in Validation testing than it may in a “normal” implementation. This often includes the critical milestone of Workbook Validation, where every configuration made in the system is systematically compared against documented values to ensure the Workbook is a full and complete blueprint of all decisions. Often, more detail is warranted than in non-Validated implementations.
- Work with your Implementation Consultant to ensure the Workbook meets your needs – and don’t be afraid to take customer ownership of it once early configuration iterations have been completed. When doing so, identify one primary owner of the Workbook who will collect and provide feedback to the Implementation Consultant on iterative changes, and who will also ensure continuity of ongoing changes to the Workbook itself.
If possible, arrange for two separate rounds of system Administrator Training
- One training should come early in the project, targeting members of your core Implementation, Data Migration, Integration and Quality workstream and ensuring that they fully understand system capabilities influencing each of their respective areas. A later round of training for all your hands-on system Administrators, so their system knowledge is fresh upon go-live.
Determine early on whether you will leverage the SAP SuccessFactors LMS Validation Toolkit
- You need to find out whether development of such templates as Risk Assessment, User Functional Requirements Specifications, Functional Requirements Specifications, Requirements Traceability Matrix, Test Scripts, Master Validation Plan, and Validation Summary Report will be handled in-house. Even if you decide to use the Toolkit, allow extra time and resource allocation for creation of custom test scenarios which may not be covered in the “out of box” ones provided in the Toolkit.
Ensure all relevant “real world” use cases are represented in your UAT/OQ (Operational Qualification)/PQ (Performance Qualification) Test Scripts.
- Increasingly, Validated customers are taking more of a “risk-based” approach to Validation testing, where OQ and PQ protocols are executed in one set of scripts. With this approach, it is most efficient to “reverse engineer” your desired end state – ensuring that only key requirements and processes are tested – vs. the opposite approach, where test cases are built based on all product capabilities (whether they will feature in your real world processes or not). The most targeted customers I’ve worked with are careful to not “lose sight of the forest for the trees” in this critical phase. Reach out to other Life Science customers via the SAP SuccessFactors Customer Community “Learning Life Sciences SIG” Group for input on their testing approach.
Take a backup of a “clean” state of configuration
- This backup should be done minus any test data or results of data migration and Connector runs so instance config can be reset to a blank slate later if needed. This is especially critical where complex data migrations and/or DMS (Document Management System) integration scenarios are involved. At minimum capture this backup in Validated Staging, with the added benefit that the backup can be applied later to Validated Production, with any interim deviations in configuration approached as a manageable delta. From a scheduling standpoint, make sure to build in adequate time for capture of and application of the backup by SAP (10 business days, although we allow 15 to be safe).
Find a trusted advisor as implementation partner.
- Trite as the saying may be, you don’t know what you don’t know. An experienced partner and Implementation Consultant can guide you through minefields of decisions, make recommendations based on real-world experience, and help you achieve your vision on time and on budget. Rizing HCM is the partner of choice for SAP SuccessFactors implementations, specializing in LMS Validated SaaS.
Taking these steps will help ensure that your SAP SuccessFactors LMS Validated SaaS implementation goes smoothly and provides the much needed training compliance that your industry demands.