Quality & Regulatory Affairs

Regulations and Compliance

Medidata is compliant with regulatory expectations for software developers and service providers within the global regulatory environment. Medidata demonstrates compliance with Good Clinical Practice (GCP), regulations including US FDA 21 CFR parts 11, 312 and 812, the EU Commission Directive 2005/28/EC and ICH E6. In so doing, Medidata can also demonstrate compliance with the ICH E6 sections on data handling and record keeping. Further, Medidata products and services are flexible and can be configured to aid and support our clients with their overall GCP compliance.

Moreover, as a Software as a Service (SaaS) provider, Medidata adheres to the data protection expectations as outlined in the US-EU Safe Harbor requirements including the Data Protection Directive 95/46/EC.

In addition, Medidata products specifically support appropriate compliance with Electronic Records and Electronic Signature (ERES) requirements including the US FDA 21 CFR part 11 and Japan’s Ministry of Health Labor and Welfare (MHLW) ERES Regulation. We provide further support to assist our clients with their ERES compliance by training users on the significance of electronic signatures and requiring documentation of such training prior to end users utilizing Medidata products.

Quality Policy

Medidata is dedicated to maintaining its position as an industry leader by providing quality SaaS-based products and professional services that satisfy our clients’ needs and expectations through conformance with declared requirements and specifications, designated quality standards and regulatory requirements. Medidata continually strives for improvements and client satisfaction in all we do.

Quality System Approach

Medidata’s Quality System incorporates policies and procedures covering, but not limited to, such areas as Management Responsibility, Internal Audits, Corrective/Preventive Action, Records Retention, Control of Quality System Records and Client Complaints.

Software Quality

All Medidata products are designed, built, validated and deployed using a standardized Medidata Software Development Life Cycle. Product releases have documented requirements and design specifications and validation plans, along with a full suite of functional, operational and performance tests. Each product release yields a Validation Certificate that includes a list of all documents that support the validated status of the product, plus release notes and impact statements.

Quality to the Client

Medidata assigns a project manager to work with every client. Quality Control verification processes are employed to ensure that the Medidata product and services solutions fully meet the client's requirements.

Quality Assurance

Medidata’s Quality & Regulatory Affairs (QRA) function is involved in all aspects of Medidata’s product and services business. Additionally, QRA oversees:

• Coordination of audits of Medidata by clients and inspections of Medidata by regulatory authorities
• The evaluations and audits of Medidata’s key suppliers
• The internal Quality System audit program
• Coordination of Medidata’s corrective and preventive action (CAPA) program
• Development and delivery of quality and regulatory training
• Dissemination of new regulatory information.