Computer Systems Validation

We are recognised as a global leader in the field of validating mission critical enterprise class applications across all areas of business. These include applications such as Enterprise Resource Planning (ERP) systems, Electronic Document Management Systems (EDMS), Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES).

Using proven methods and procedures, tools and templates from our ISO 9001:2000 registered Validation Library, our risk-based approach to computer system validation is acknowledged to be one of the most cost-effective ways to achieve and maintain a validated state for all mission critical applications.  

Information Systems Compliance

Addressing issues such as IT infrastructure qualification and IT best practice, our process-based approach to Information Systems (IS) compliance allows our clients to focus on defining and implementing efficient IS best practice while assuring that their processes meet regulatory expectations.

Whether defining an IS Strategy, developing an IS Quality Management System or whether addressing specific aspects of IS compliance, our use of IT industry standards such as CoBiT, ITIL and ISO allows us to maximise the sense of ownership within the IS Group.

Considering people, processes and procedures as well as the latest technology, our IS compliance teams help clients to optimise operations and control costs while simultaneously meeting the requirements of multiple regulatory agencies
 

Regulatory Compliance Assessments

Most assessments of computer systems fail to address all of the dimensions that are required to assure regulatory compliance. Even recent assessments conducted to assure compliance to 21CFR Part 11 (or other Electronic Record, Electronic Signature) fail to address important issues such as compliance with the predicate rules or procedural compliance to assure audit trail security.

Our Regulatory Compliance Assessment (RCA) methodology covers all aspects of regulatory compliance, including the capability of an organisation to maintain and support a system in a compliant state. It also assesses the efficiency of business processes by identifying optional transactions that are not mandated by regulatory requirements.

For large mission critical systems such as ERP systems and LIMS, we use a standard model to check conformance against the requirements of the predicate rules. We have mapped the majority of predicate rules and have developed specific models to accelerate the assessment of systems such as SAP R/3, Oracle E-Business Suite and Ross iRenCS. We also have generic models to assess the compliance of systems such as laboratory systems used in clinical trials, manufacturing execution systems, computer aided design and electronic document management systems.
 

Regulatory Compliance Health-Check Assessment

For organisations requiring a more focused overview of their state of compliance, we also offer a 'health-check' to identify high level compliance risks associated with mission-critical systems. It is suitable for companies owning new systems through corporate acquisition, or as a cross-check against changes in regulations or changes in system use.