The failure to identify data integrity issues presents a substantial business risk. Consequences start with delays to license approvals, but can extend as far as restricting access to markets for all the products in your portfolio. As global regulatory agencies increasingly share information, a problem in one jurisdiction is more likely to become a problem in other jurisdictions too.
PAREXEL’s Strategic Compliance and Risk Management team leverages decades of experience in detecting and preventing data integrity issues so that clients have sound systems and protocols they can rely on. Within this article, our experts outline applicable FDA and global regulations, guidance and reports on data integrity as well as how they view the newest trends and regulatory changes.