Validated Learning Management in Life Sciences

Training that holds up when the auditor asks for proof.

An SOP revision occurs on Monday. By Friday, an inspector will be demanding evidence that retraining has occurred and that a signature record, compliant with 21 CFR Part 11, has been obtained, along with evidence that the system for storing them has been qualified. Missing one means you get a finding.

In life sciences, a training record is not just another HR artifact. Training records are regulated data, and the system used to store them is a validated system – one subject to change control and validation like any other GxP system. Old-school platforms may capture completion, but they do not validate control.

SAP SuccessFactors Validated LMS (vSaaS) was built with these requirements in mind: an annual release cycle to allow for proper validation, e-signatures and audit-trail capabilities included in the environment, and a distinct Validated Learning mobile application for use by individuals who are working off of their desks.

This on-demand webinar discusses the implementation and operation of a validated learning environment: What does validation cover? What remains your responsibility? Where are the areas in which projects go off the
rails and how do you stay audit-ready?

What You’ll Walk Away With

Practitioner-focused session based on issues that occur in regulated organizations:

• Validation of SaaS vs. standard SuccessFactors Learning — cadence, documentation, and where SAP’s responsibility ends
• 21 CFR Part 11 and EU Annex 11, translated into real configuration: e-signatures, audit trails, access control, retention
• A validation path through IQ, OQ, and PQ that QA signs off on without a year of paperwork
• Linking your QMS or document system so that a revised SOP assigns its own training
• Surviving the annual release — impact assessment, regression testing, change control
• Curricula and role-based qualifications that hold up across sites and geographies
• The reports and evidence trail that an auditor reaches for first
• Where partner experience saves months, and which decisions deserve more time