Demos
A look at some of my projects and tools.
GxP Compliance Platform for Training, Documentation and Recordkeeping
Regulated industries face strict requirements for training records, document control, and auditability. When these processes are handled manually or via disconnected point solutions, gaps emerge that can lead to findings during inspections.
Our platform consolidates the core compliance processes into a single system.
Feature overview:
Training management: Delivery and proof of mandatory training, including knowledge assessments. Completions are documented with a legally binding electronic signature, as required by relevant regulations (e.g. 21 CFR Part 11).
Document control: Management of controlled documents (e.g. work instructions) across their full lifecycle — draft, approval, release, withdrawal — with a four-eyes principle for approval.
Onboarding and role assignment: Structured onboarding processes with automatic assignment of required training based on role.
Auditability: Tamper-proof logging of relevant events for full traceability during audits and inspections.
Data protection and retention: Support for deletion requests and enforcement of defined retention periods as an integral part of the processes.
Multi-tenancy: Clean organizational and technical separation of multiple sites or business units within the same system instance.
The goal is to systematically and verifiably meet legal and regulatory requirements for training and documentation processes, with reduced manual effort and lower risk during regulatory inspections.