Lumenia specialises in regulatory software testing and computer systems validation services, particularly ERP system validation, helping clients to ensure that key business systems are fully functional and in compliance with applicable regulations.
Our validation consultants all have GxP/FDA/MHRA environment experience preparing validation lifecycle documentation, conducting vendor audits, performing systems assessments and preparing protocols. We have successfully led ERP system validation processes across a range of medical device, pharmaceutical and bio-pharmaceutical companies.
Our risk-based approach ensures that your systems will comply with all regulatory constraints in an efficient and cost-effective manner.
How our ERP System Validation Services Add Value
Save Time & Money
We help our clients to save time and money by using experience to minimise the effort involved in ERP system validation, while ensuring that the system will fully comply with all applicable regulations.
Ensure Audit Compliance
We have extensive experience of regulatory audits, and of the questions that auditors are likely to ask. We will use this experience to ensure that the ERP system is fully “audit-proof”.
Minimise Documentation Effort
We take a practical view based on the GAMP® 5 Risk-Based Approach to achieving compliance to minimise the level of documentation required to support the ERP system validation process.
Reusable Validation Model
Our approach to ERP system validation is fully reusable and the framework can be applied to other computer systems validation processes, thus reducing effort and cost on future technology projects.
We can support your computer systems validation project by producing any of the following deliverables.
Validation Master Plan
Documentation of the validation master plan setting out the overall validation strategy and defining who is responsible each activity.
Functional Risk Assessment
Leading risk assessment sessions to ensure an appropriate risk rating is assigned from a compliance perspective.
Vendor Audit Preparation & Execution
Preparation of vendor audit criteria and checklist, delivery of the audit and production of the audit report
User Requirements Documentation
Critical review and provision of feedback on user requirements documentation to ensure compliance with relevant regulatory standards.
Protocol Development and Review
Development or critical review of test plans, scripts and validation protocols (i.e. IQ, OQ, PQ).
System Compliance Support
Critical review of validation reports to ensure all required validation deliverables are in place and ERP system meets compliance requirements.
Benefits of Lumenia ERP System Validation Management
Experience & Expertise
Our computer system validation services are all led by consultants who have extensive experience in GxP/FDA/MHRA environments, and specific expertise in the full ERP system validation life cycle.
We use our experience to help chart a path to ERP compliance that minimises the amount of effort required by the systems validation and ERP project teams.
Best Industry Practises
We apply a best practise approach to our ERP system validation methodology and associated templates based on GAMP® 5 and up-to-date industry standards.