ERP/Business Systems Validation

Validation of corporate Business Systems (SAP, Oracle etc) and overall business risk is increasing as regulatory bodies such as FDA and MHRA are becoming more experienced in their inspections.

We at Clarity Compliance Solutions continue to help our clients meet regulatory demands from Blueprint to go-live operation.

In addition to the Computer Systems Validation services we also deliver the following:

• Project Definition
  Project assessment process, validation planning, risk assessment (GxP and project).
• Business Blueprint
  Integrate the regulatory requirements into your business blueprints – capture and specify master data, security, technical and module functional requirements.
• Business Process Mapping
  Integrate quality and validation requirements into your data flows, transactional analysis and interfaced systems.
• Realisation
  Leverage testing by your system implementer and integrate validation into your overall project testing of transactions, workflows, data migration and configuration.
• Final Preparation
  Training of project team and end users, data harmonisation and migration activities.
• Release and Use Cut-over
  Planning and cutover activities, validation reports and release management.
• Go-live and Support
  Cut-over report and performance monitoring.