How confident are you that your data is complete, secure and accurate?

A drug’s safety requirements extend beyond clinical trials and must be upheld through sound quality by design (QbD) principals and continual process monitoring and control, confirmed with a rigorous quality control (QC) testing programme. As the foundation for current good manufacturing practice (cGMP) compliance, data is an essential component of an organisation’s quality system. Patients expect their medications to be safe and effective. At the heart of this expectation is the data that drives everyday decisions in the QC laboratory. Ensuring it is accurate, relevant and reliable is critical to support confident decisions on product quality and patient safety. With an increase in US Food and Drug Administration (FDA) warning letters and cGMP inspection violations, regulatory agencies are setting the expectation that organisations be proactive in their efforts to adhere to data integrity laws, regulations and best practices.