SERVICES OFFERED

Services for Regulated Healthcare Companies

We can provide a number of services including:

• Creation of Quality Improvement Plans and risk based strategies to address IT compliance and data integrity gaps
  

• Development or improvement of an IT Quality Management System which will meet regulatory requirements and industry standards

• Leadership of the Computer System Validation (CSV) element of IT implementation projects

• Creation of required CSV documentation across the system lifecycle

• Advice on the qualification of infrastructure (servers, platforms, networks, data centres, etc.) and the ongoing maintenance of the qualified state

• Supplier assessment and on site audit, tailored to the type of supplier and the product / service they provide

• Inspection readiness preparations including in depth audits of your existing systems to identify gaps or non-compliances

• A range of training options including individual electronic training modules and on-site training.

Services for IT Suppliers

We can provide a number of services to IT suppliers to improve the overall product you offer to your customers including:

• GxP Awareness training
  

• Assessment of current status to determine your readiness for customer supplier assessments / audits

• Creation / improvement of a Quality Management System that works for you  and will be acceptable to your customers

• Identification of enhancements that might better enable your customers to comply with applicable regulations

• Creation of suitable, pre-filled questionnaires that you can provide to your customers during supplier assessments

• Creation of a validation package for your product which you can provide to your customers.