Recent trend on 483s and warning letter due to data integrity issues are increasing.

Pharmaceutical companies face significant challenges when it comes to maintaining data integrity. The FDA and all other health authority have strict regulations and guidelines in place to ensure that data is accurate, complete, and reliable. Failure to comply with these regulations can result in severe consequences, such as legal action, fines, and damage to a company's reputation.

At the same time, you are facing following challenges to maintain data integrity:

• Deficiency or absence of procedure on data integrity
• Deficiency in technical control in equipment and systems
• Deficiency or absence of data integrity governance structure
• Lack of understanding

Our Solutions for You:

• You will get a comprehensive gap assessment report based on the DI Assessment of your facility.
• You will get a remediation plan to mitigate the identified gaps.
• You will get necessary support to develop an effective data integrity governance structure.
• You will receive a training on Data Integrity Foundation.

Our solutions are designed to help you avoid the challenges associated with data integrity issues and ensure that your company is meeting regulatory requirements and guidelines. Contact us today to learn more about how we can help you maintain data integrity and avoid costly consequences.