Focusing on Data Integrity
Data Integrity (DI) is critical for maintaining the reliability, accuracy, and completeness of data throughout the pharmaceutical lifecycle. In an increasingly digital environment, ensuring data integrity is essential for compliance with regulatory requirements and maintaining public trust in the integrity of pharmaceutical products.
Data integrity is a significant component of a pharmaceutical company’s Quality System. Data integrity provides foundational assurance that the data the company uses to demonstrate that its products are safe and effective for their intended use are in compliance with regulatory requirements. A data integrity program recognizes the company’s responsibility to prove the origin, transmission and content of the company’s data are unaltered and secure.
Data integrity is a major global concern of Health Authorities and the pharmaceutical industry. Numerous recent Health Authority enforcement actions, such as Warning Letters, Import Alerts, Product Detentions and suspension or revocation of Marketing Authorizations, have focused attention on data integrity. Regulators consider the integrity of data, from the moment it is generated to the end of its life cycle, to be a critical component of ensuring that only high-quality and safe drugs are manufactured. Data integrity is typically defined in the pharmaceutical industry using the acronym ALCOA+. Data must be Attributable, Legible, Contemporaneously recorded, Original, and Accurate, plus Complete, Consistent, Enduring, and Available.
FDA has cited data integrity violations frequently. Common findings typically point to violating principles of ALCOA+, 21 CFR Part 11, and the FDA’s Data Integrity Guidance document. Audit findings have included:
- Deletion or manipulation of data
- Invalidated OOS results without justification
- Destruction (intentional or otherwise) or loss of data
- Failure to document work contemporaneously
- Uncontrolled documentation
While data security is not a new concept, there is increased scrutiny of data integrity and 21 CFR Part 11 compliance as electronic records have become the industry standard. For manufacturers trying to attain a high degree of data integrity, the FDA’s Data Integrity, and Compliance with Drug CGMP Guidance for Industry document is a great tool to frame an approach to vigorous internal policies. This document is often referenced in FDA warning letters when companies are in violation of principles stated in the guidance. Manufacturers are expected to implement effective and robust strategies to ensure that accurate and secure data management systems are in place and routinely monitored by the quality unit.
A secure quality system must be in place to prevent any intentional or unintentional loss of CGMP data. Software programs used with automated process control and analytical instruments should be designed from inception to prevent loss of data under any circumstance. Secure software will help to mitigate risks for data integrity violations. Software programs must offer audit trails, various user permissions, the inability to delete data, and many other features making it simple to automate compliance to data integrity guidance and 21 CFR Part 11. Data, whether paper or electro