Anthem - Compliance and Computer System Validation

Compliance and Computer System Validation

	Compliance and Computer System Validation We partner with our clients, working with them to define the road to compliance within their environment. At the heart of our services is a thorough understanding of compliance. We have an in-depth understanding of international regulations and assist our clients in staying up to date and responding to the latest developments in regulatory compliance. Our well-defined structured methodology and approach follows best industry practices and complies with all international agency requirements. We follow internationally accepted GAMP 5 guidelines and its current interpretations for validation of computer systems applying Risk Based Approach and Life Cycle Management philosophy. Our team is well versed in US FDA 21 CFR Part 11 as well as EU Annexure 11 requirements, and can work with your organization to develop a structured methodology for achieving 21 CFR Part 11 Compliance while leveraging a risk based, scientific approach.
	Our Major Services in Computer System validation are as under: Process Control (PLC/ SCADA / BMS) System Validation Software (ERP/SAP) Validation Laboratory Computerized System Validation IT Infrastructure Qualification Prepare Test Protocols Periodic Review & Audit Support Vendor Assessment