We’re excited to announce that Amazon Web Services (AWS) has completed the first cloud service provider (CSP) audit by the Ingelheim Kreis (IK) Initiative Joint Audits group. The audit group represents quality and compliance professionals from some of our largest pharmaceutical and life sciences customers who collectively perform audits on their key suppliers.

   <p>As customers embrace the scalability and flexibility of AWS, we’re helping them evolve security, identity, and compliance into key business enablers. At AWS, we’re obsessed with earning and maintaining customer trust. We work hard to provide our pharmaceutical and life sciences customers and their regulatory bodies with the assurance that AWS has the necessary controls in place to help protect their most sensitive data and regulated workloads.</p> 
   <p>Our collaboration with the IK Joint Audits Group to complete the first CSP audit is a good example of how we support your risk management and regulatory efforts. Regulated pharmaceutical and life sciences customers are required by <a href="https://aws.amazon.com/compliance/gxp-part-11-annex-11/#:~:text=GxP%20is%20an%20acronym%20that,devices%2C%20and%20medical%20software%20applications." target="_blank" rel="noopener">GxP</a> to employ a risk-based approach to design, develop, and maintain computerized systems. GxP is a collection of quality guidelines and regulations that are designed to ensure safe development and manufacturing of medical devices, pharmaceuticals, biologic, and other food and medical products. Currently, no specific certifications for GxP compliance exist for CSPs. Pharmaceutical companies must do their own supplier assessment to determine the adequacy of their development and support processes.</p> 
   <p>The joint audit thoroughly assessed the AWS controls that are designed to protect your data and material workloads and help satisfy your regulatory requirements. As more pharmaceutical and life sciences companies use cloud technology for their operations, the industry is experiencing greater regulatory oversight. Because the joint audit of independent auditors represented a group of companies, both AWS and our customers were able to streamline common controls and increase transparency, and use audit resources more efficiently to help decrease the organizational burden on both the companies and the supplier (in this case, AWS).</p> 
   <h2>Audit results</h2> 
   <p>The IK audit results provide IK members with assurance regarding the AWS controls environment, enabling members to work to remove compliance blockers, accelerate their adoption of AWS services, and obtain confidence and trust in the security controls of AWS.</p> 
   <p>As stated by the IK auditors, “…in the course of the Audit it became obvious that AWS within their service development, their data center operation and with their employees acts highly professional with a clear customer focus. <strong>The amount of control that AWS implemented and continuously extends exceeds our expectations of a qualified CSP</strong>”.</p> 
   <p>The report is confidential and only available to IK members who signed the NDA with AWS prior to the start of the audit in 2023. Members can access the report and assess their own residual risk. To participate in a future audit cycle, contact <a href="mailto:joint-audits@pharmadvantage.it">joint-audits@pharmadvantage.it</a>.</p> 
   <p>To learn more about our commitment to safeguard customer data, see <a href="https://aws.amazon.com/security" target="_blank" rel="noopener">AWS Cloud Security</a>. For more information about the robust controls that are in place at AWS, see the <a href="https://aws.amazon.com/compliance/programs/" target="_blank" rel="noopener">AWS Compliance Program</a> page. By integrating governance-focused, audit-friendly service features with applicable compliance or audit standards, AWS Compliance helps you set up and operate in an AWS control environment. Customers can also access <a href="https://aws.amazon.com/artifact/" target="_blank" rel="noopener">AWS Artifact</a> to download other compliance reports that independent auditors have evaluated.</p> 
   <h2>Further reading</h2> 

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