Regulatory Compliance

We have strong regulatory compliance capabilities, and help life sciences organizations adhere to 21CFRPart 11 regulations. Our Pharma Quality Management System bridges the traditional SDLC with Part 11 requirements—delivering validated systems to our customers.

In this area, we:

• Conduct gap analysis for compliance with 21CFRPart11 regulations
• Establish user identity, user accountability, and procedures in various SOPs for developing, maintaining, administering, or using a system
• Test and validate systems to ensure accuracy, reliability, and operational consistency
• Define enterprise-wide security policies
• Design audit trials and archiving mechanisms
• Establish and implement document control procedures
• Implement electronic signatures

Additionally, we have a practice dedicated to ensuring clients comply with the Sarbanes Oxley Act of 2002—a US law designed to improve corporate responsibility and accountability, enhance financial reporting and disclosures, and ensure auditor independence. Section 404 of the Act requires companies to assess the adequacy of internal controls related to financial transactions and financial reporting, and report on their assessment annually. We have a comprehensive approach—it leverages automated tools—to identify, remediate, mitigate, and prevent any SoD violations.

Our SOX compliance approach includes the following steps:

• A validation plan covers system configuration and testing for SOX compliance.
• The tool is tested to identify SoD violations based on rules configured within the application.
• A deployment plan and report related to all activities are created.
• A validation report is written after the final implementation of the tools.

Back