I was recently involved in implementation of Success Factors Validated LMS(VLMS) for a US based life sciences organization.
I would like to share some of my experience implementing the solution coupled with what SAP SuccessFactors provides with VLMS solution. In this article I will mainly focus on Validation aspect and not on details of implementing LMS solution.
Let’s first understand what Validated SaaS is and why it is required:
Validation is governed by guidelines from the Federal Food and Drug Administration (FDA) and is prevalent in the life sciences industries. The goal is to document procedures and processes to demonstrate that results are consistent. Consistent results lead to a better controlled environment for the development of products. Validation ensures FDA compliance.
Validated SaaS has benefits for highly regulated environments because it provides a way to comply with regulatory bodies. Validated SaaS provides a consensus-based service designed to meet the FDA 21 CFR Part 11/validation requirements. Life Science Industries can reduce costs and IT resource needs. This process also ensures FDA compliance and GxP processes.
For organizations that need to regulate, qualify, and certify their employees, SAP SuccessFactors Learning allows them to automate and assure compliance training. Validation is not standard across industries or customers but it usually requires highly detailed documentation. The documentation is time consuming to produce. It usually takes three-to-six months.
As a result of the validation requirements, customers cannot receive quarterly release updates. Instead, these customers need an annual release schedule. For these customers, SAP SuccessFactors offers SaaS at a slower cadence and with some additional validation reporting features. This allows time for them to produce the documentation they need to meet their validation requirements.
The slower release cadence and additional validation reporting is called Validated SaaS, or vSaaS.
Validated SaaS Qualification
A Validated SaaS customer need to show installation, operational, and performance qualification.
Installation Qualification (IQ) Reports are relevant to SAP SuccessFactors. The SF Operations team provides documentation of initial set up of the application and database that demonstrates all of the required steps were followed for proper installation in the environment.
Operational Qualification (OQ) and Performance Qualification (PQ) are relevant to Validated SaaS clients. With OQ, customers test application functionality and document actual-versus-expected results, similar to User Acceptance Testing (UAT). With PQ reports, customers test application functionality based on their business processes, use cases, and data to ensure the product will work as designed.
Learning Validated SaaS Release Schedule and Environments
SAP SuccessFactors Learning Validated Software as a Service (vSaaS) releases annually and rolls up all quarters in the year.
SAP SuccessFactors Learning Validated Software as a Service (vSaaS) is released in Q3 of every year. It includes all features released in the last year, starting with Q4 of the previous calendar year. For example, the Validated SaaS release of Q3 2017 includes Q4 2016, Q1 2017, Q2 2017, and Q3 of 2017, all in a single release.
The following instances are included in a Learning Validated SaaS:
BizX Foundation is a requirement for all customers, and is the entry point for HR user data which then feeds Validated LMS.
Supported Integrations for Validated LMS
Validated LMS works with following products in SAP SuccessFactors:
Key Points based on Implementation experience
I am listing here some of the points which we experienced during the implementation and hope it will help others too:
Please feel free to comment or add anything on this.
Thanks
I would like to share some of my experience implementing the solution coupled with what SAP SuccessFactors provides with VLMS solution. In this article I will mainly focus on Validation aspect and not on details of implementing LMS solution.
Let’s first understand what Validated SaaS is and why it is required:
Validation is governed by guidelines from the Federal Food and Drug Administration (FDA) and is prevalent in the life sciences industries. The goal is to document procedures and processes to demonstrate that results are consistent. Consistent results lead to a better controlled environment for the development of products. Validation ensures FDA compliance.
Validated SaaS has benefits for highly regulated environments because it provides a way to comply with regulatory bodies. Validated SaaS provides a consensus-based service designed to meet the FDA 21 CFR Part 11/validation requirements. Life Science Industries can reduce costs and IT resource needs. This process also ensures FDA compliance and GxP processes.
For organizations that need to regulate, qualify, and certify their employees, SAP SuccessFactors Learning allows them to automate and assure compliance training. Validation is not standard across industries or customers but it usually requires highly detailed documentation. The documentation is time consuming to produce. It usually takes three-to-six months.
As a result of the validation requirements, customers cannot receive quarterly release updates. Instead, these customers need an annual release schedule. For these customers, SAP SuccessFactors offers SaaS at a slower cadence and with some additional validation reporting features. This allows time for them to produce the documentation they need to meet their validation requirements.
The slower release cadence and additional validation reporting is called Validated SaaS, or vSaaS.
Validated SaaS Qualification
A Validated SaaS customer need to show installation, operational, and performance qualification.
- Installation Qualification (IQ): Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Installation Qualification (IQ) Reports are relevant to SAP SuccessFactors. The SF Operations team provides documentation of initial set up of the application and database that demonstrates all of the required steps were followed for proper installation in the environment.
- Operational Qualification (OQ): Demonstrates that all facets of the process or equipment are operating correctly.
- Performance Qualification (PQ): Demonstrates that the process or equipment performs as intended in a consistent manner over time.
Operational Qualification (OQ) and Performance Qualification (PQ) are relevant to Validated SaaS clients. With OQ, customers test application functionality and document actual-versus-expected results, similar to User Acceptance Testing (UAT). With PQ reports, customers test application functionality based on their business processes, use cases, and data to ensure the product will work as designed.
Learning Validated SaaS Release Schedule and Environments
SAP SuccessFactors Learning Validated Software as a Service (vSaaS) releases annually and rolls up all quarters in the year.
SAP SuccessFactors Learning Validated Software as a Service (vSaaS) is released in Q3 of every year. It includes all features released in the last year, starting with Q4 of the previous calendar year. For example, the Validated SaaS release of Q3 2017 includes Q4 2016, Q1 2017, Q2 2017, and Q3 of 2017, all in a single release.
| VLMS Q3 2017 Release (1708) | 1611, 1702, 1705, 1708 (all 4 in Annual release) |
| BizX | Quarterly Release |
The following instances are included in a Learning Validated SaaS:
BizX Foundation is a requirement for all customers, and is the entry point for HR user data which then feeds Validated LMS.
Supported Integrations for Validated LMS
Validated LMS works with following products in SAP SuccessFactors:
- Single Sign-On (SSO) authentication
- Theming (branding)
- Learning Management System (LMS) and Career Development Plan (CDP) integration
- SAP Jam
- User information synchronization
- Competency synchronization
- Employee profile
- Validated SaaS Mobile Application
Key Points based on Implementation experience
I am listing here some of the points which we experienced during the implementation and hope it will help others too:
- SAP doesn’t release all the 4 LMS instances in the beginning after the procurement process of VLMS is completed.
- Instances would be released sequentially based on below approach:
- Customer has to sign off successful tests performed by the Implementation Partner in the sandbox tenant.
- Then the Implementation partner creates a support ticket and provides customer Sign-off along with order form for that customer with SAP.
- Then the next instance will be released to the customer via email from the SAP Provisioning team. This process is repeated until all instances are provided.
- You would receive 2 BizX instances, 1 LMS Instance, 1 iContent server, 2 sFTP servers for BizX and 1 sFTP server for LMS to start with.
- There are only 2 BizX instances (Sandbox and Production) which comes as part of VLMS purchase
- Release cycle is Annual for VLMS as mentioned above and Sandbox and Staging fall under preview release cycle, whereas, Pre-Prod and Prod LMS instances would be under Production cycle release.
- Only SF LMS is validated, other components like Employee Profile, SSO integration are non-validated.
- Employee Profile (BizX part) will have normal quarterly release cycle.
- SAP provides IQ Report which quantifies that LMS is installed and the database for same. Validation team of our client also asked for another IQ to be done as even though its out-of-the-box vanilla implementation, we still need to configure things to make LMS run like Domains, AP’s, other settings etc. (this may differ based on validation team of respective clients) as per client requirements.
- All team members working on IQ/OQ reports had to undergone quality training as per client’s SOPs.
- One key problem we faced was that until Production, we couldn’t test the entire end-end flow for a user i.e. Login using SSO into SF BizX and access their Employee Profile and then move to My Learning/Learning Admin page in LMS as per their roles in LMS. This is basically due to only 2 BizX instances and only Production instance has a validated LMS along with BizX.
- There is one Validated SaaS Group in SF community portal – “Validated SaaS Learning Communication”. It provides special documents, release schedules, and notices that are specific to Validated SaaS Learning clients. This group is only open to current SuccessFactors Validated SaaS life science, pharmaceutical, and medical devices companies under FDA Regulation. It is not open to non-Validated SaaS customers or any implementation partners at this time.
- This group also provides Validation Tool Kit, which includes different Test Plans, OQ/PQ Protocol samples, Test scenarios, Test Scripts etc. for every release annually.
Please feel free to comment or add anything on this.
Thanks
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