Data integrity within a CGMP environment is defined as “the assurance that data records are accurate, completed, intact, and maintained within their original context, including their relationship to other data records”. This requirement applies to paper, electronic, and hybrids of both electronic and paper records to ensure that data is reliable, true and accurate.
The FDA and other regulatory agencies expect data to be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models.
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.
Staying off the regulatory radar requires a quality approach to manufacturing. Companies operating in the life sciences space must see to it that effective controls and oversight are implemented in advance of inspections. Every effort should be made to ensure the accuracy and reliability of data so instances of contamination, mix-ups, and errors can be eliminated, and consumers are protected from buying products that are either ineffective, or hazardous to their health. Kymanox provides the knowledge and expertise that empowers Life Sciences organizations globally to accelerate growth and move from compliance to performance to ensure your organization avoids CGMP issues involving data integrity.