Services offered

Quality System development to meet international regulatory requirements and other guidance and standards (e.g. GxP, GAMP®, ITIL®).
Development of strategies to support a risk-based approach to the quality and data integrity compliance.
Assessments of suppliers in support of computerised systems validation (CSV).
Auditing of systems, sites and projects to ensure compliance with regulatory expectations in respect of computerised systems operation and support.
Understanding the approach to, and performance of risk assessments associated with IT service provision and CSV.
Creation of CSV documentation throughout the full life cycle (planning, specification, implementation, operation and retirement).
Working within a larger project team to advise on organising for successful validation.
Enabling suppliers to understand the requirements of their pharmaceutical and life sciences industry customers.
CSV training (internal and external).