validation

Our consultants and practitioners are able to support our clients in all aspects of computer system and process equipment validation

Strategy Development

Our consultants work with senior management teams in order to provide understanding of the business benefits derived from regulatory compliance and the risk of non-compliance. Corporate and Site validation strategies are developed in order to provide a risk-based solution to compliance deficiencies.

Validation Infrastructure

We are able to develop validation processes, procedures and systems based of industry standard development and operational lifecycles. Customer personnel are actively engaged in the development of such processes, procedures and systems in order to ensure appropriate buy-in.

Skills development processes establish the necessary competencies within the organisation to ensure systems are appropriately applied, monitored and maintained.

Validation Planning

Site Validation Plans are developed to provide a prioritised approach to facility, equipment and computer systems validation. Maintainable inventories are established in order to identify critical systems requiring validation and their current validated status.

Delivery

We offer managed project teams or key individuals to supplement a customer’s internal team in order to meet prospective or retrospective validation needs. Our consultants and practitioners are competent in all aspects of validation associated with system development and operation. Typical services provided include but are not limited to:

Validation Planning
Supplier Auditing
User Requirements Definition and Review
Risk Assessment
Design Specification and Qualification
Software Code Review and Configuration Management
Pre-Delivery Testing
Post Delivery Testing and Qualification
Data Migration
System Cut-over
Validation Reporting
Post Implementation Monitoring
Operational Compliance