Validation and Part 11 Compliance Services

With increasing regulatory scrutiny and requirements to comply with national and international regulations, more and more companies are moving to replace manual and paper-based processes with automated systems. Due to their experience and background, CSI consultants are well equipped to qualify your systems of varying levels of complexity and help you stay compliant. CSI optimizes the time and cost of validation by applying a risk-based approach to each system. CSI can also provide a wide range of automated tools as part of the consulting engagement to provide you with sustainable compliance.

CSI is a recognized leader in providing compliance solutions to the FDA-regulated industry with a global client base that spans North America, Europe and Asia. CSI consultants combine regulatory knowledge with technical expertise to provide solutions to issues instead of simply highlighting them. CSI follows the FDA-recommended GAMP 4 methodology for all validation services. CSI's validation methodologies have been developed after years of real-world field experience to ensure successful project outcomes. We strive to deliver value as an added ingredient in all our deliverables with a view to improving operations and productivity and simplifying processes with compliance as a by-product.

CSI offers a wide range of services that include validation planning, risk assessments, Part 11 assessments and remediation plans, preparation of validation documents and SOPs, protocol execution, deviation resolution and training. CSI regularly contributes to industry conferences, journals, tradeshows and events and is in tune with current FDA thinking and future direction.