Solutions
Support for every GxP role.
From QA and QC to regulatory affairs, validation and production. For individuals and for organisations.
01
Quality Assurance
Oversight of deviations, CAPA, change control, documentation, audits and training.
Key challenges
Deviations and CAPADocumentationAudits and inspectionsTraining
Relevant modules
Example workflow
Understand the requirementAssess the issuePrepare documentationReview evidenceTrack follow-up
Type of support
Learning, drafting assistance, inspection rehearsal and structured risk assessment.
02
Quality Control
Laboratory testing, data review and investigations.
Key challenges
OOS and OOT investigationsData integrityAudit trail reviewMethod changes
Relevant modules
Example workflow
Review the dataCheck the audit trailDocument observationsEscalateClose the investigation
Type of support
Scenario training on data integrity, drafting support for investigations and fast document retrieval.
03
Regulatory Affairs
Submissions, variations and interactions with health authorities.
Key challenges
Changing requirementsMultiple jurisdictionsSubmission writingHealth authority questions
Relevant modules
Example workflow
Identify the requirementCompare jurisdictionsDraft contentCheck referencesSubmit after review
Type of support
Regulatory research with sources, writing assistance and structured learning paths.
04
Validation and Qualification
Equipment, process, cleaning and computerised system validation.
Key challenges
Risk-based scopeProtocol writingComputerised systemsPeriodic review
Relevant modules
Example workflow
Assess riskDefine scopeDraft protocolExecute and reportReview periodically
Type of support
Risk scoring, protocol drafting assistance and links between validation documents.
05
Manufacturing and Operations
Production, packaging and day-to-day GMP decisions.
Key challenges
Shop-floor deviationsLine clearanceOperator trainingChanges on the line
Relevant modules
Example workflow
Detect the eventSecure the productRecord the factsEscalate to QAApply the lesson
Type of support
Short practical scenarios, risk-based thinking and clear access to procedures.
06
Biotech and Medical Devices
Growing biotech companies and device manufacturers with their own frameworks.
Key challenges
Building a QMSISO 13485 and ISO 14971Scaling teamsFirst inspections
Relevant modules
Example workflow
Map the frameworkTrain the teamDocument processesAssess risksPrepare for audit
Type of support
Foundational pathways, risk management support and documentation assistance.
Who it serves
Value for individuals and for organisations.
For professionals
- Learn GxP at your own pace
- Practise decisions before they matter
- Grow your career with structured pathways
- Find answers with visible sources
For organisations
- Consistent, role-based training
- Structured first drafts with visible gaps
- Rehearsed inspection readiness
- Shared, traceable regulatory knowledge
Let's talk
Shape the future of pharmaceutical compliance with us.
Book a demo of the interactive previews or join the pilot programme.
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