Quality Assurance & Auditing
We provide quality assurance and auditing expertise in the area of Federal Regulations regarding the validation of computer systems, computer applications and regulated manufacturing areas and supporting systems. This includes the review of subject system and associated documentation for compliance with current interpretations of Federal Regulations and best industry practices. In addition, recommendations are offered for remediating risk areas and systems, with exceptional practices and equipment. We also provide Regulatory Audits such as Pre-approval inspections, FDA preparedness audits, vendor audits and internal audits.
Sarbanes-Oxley (SOX)
We understand the unique Sarbanes-Oxley (SOX) compliance challenges that life science companies face. Our SOX compliance strategy focuses on Section 302 (Chief executives must take personal responsibility for the accuracy of all financial statements) and Section 404 (Various internal controls must be in place to curtail fraud and abuse).
Our industry experience and regulatory expertise allows us to provide you with value based business solutions. We do this by leveraging your existing quality systems to achieve SOX compliance in a cost effective manner.
We will collaborate with you to achieve SOX compliance while maintaining shareholder value. We will work with your internal team, external auditors and business allifiates to develop a streamlined process for SOX compliance.
Our approach includes regulatory advice, training and hands-on implementation assistance. As a Stelex Client, you can be confident that you have chosen a total compliance solutions provider.
About Our Methodology
We have developed a methodology to meet the specific needs of each company. Our methodology leverages the quality systems you have developed to comply with regulations to achieve compliance.