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Our Regulatory Experience
The business world is becoming more regulated each year. It is important for you to know that we pay attention to the current regulations, including FDA regulations for our pharmaceutical clients or the new Sarbanes-Oxley rules for publicly traded companies. We have worked in these environments and know what needs to be done to protect our clients.
Sarbanes-Oxley 302 and 404 Compliance
The Sarbanes-Oxley Act of 2002 (SOX) has rewritten the rules for corporate governance, disclosure, and reporting. SOX makes the CEO's and CFO's explicitly responsible for effective internal controls over financial reporting and disclosure. What does this have to do with IT? Mainly SOX section 404 requires effective internal control over financial reports. Often data coming from data warehouses and data marts via the business intelligence architecture feeds the financial reporting process. Any publicly traded company must have these internal controls in place. SOX section 303 is not directly IT related but covers the validation of design and effectiveness of disclosure controls and procedures. We are available to perform retrospective audits of your reports to insure it complies with SOX section 404. We can also assist in setting up your SOX 404 controls.
FDA Software Validation
The biotech and pharmaceutical industries require complete software validation in accordance with FDA cGMP guidelines. We have the resources and expertise to validate both custom and commercially available software.
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