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.

Our ERP/Business Systems Validation Training Courses

Gain the skills and knowledge that will better enable you to make organisational change, take control of your project outcomes, reduce costs and your audit exposure.

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+44 (0)1633 400939

+44 (0)7735 204233

Quality Managment Systems – Policies & SOPs

We can support you by reviewing your current QMS or tailoring our own QMS to meet your needs.

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Lead, Drive and Deliver ERP/Business System Implementation

Our Approach

Our risk based approach to criticality assessments and associated validation strategy ensures a cost effective approach to ERP/Business system compliance. We focus effort and resources on critical areas resulting to reduce validation costs for the project.

Delivering Business Benefits

With an integrated approach to organisational change, project management and validation Clarity Compliance Solutions can deliver the greatest business benefit in terms of business operation, project outcome and audit exposure.

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