Regulators have high expectations regarding Data Integrity (DI) in the life sciences sector. Good data practices must be applied to processes embedded in computerised systems and automated systems, but also to data storage in the cloud and to paper-based processes. Any regulated life sciences company needs to make strategic decisions about the management of its manufacturing and laboratory data in order to comply with regulations. In recent years, there has been an increase in the number of data handling violations and other data-related issues at pharmaceutical manufacturing facilities, during GMP inspections by regulatory authorities. Because of these frequent violations of basic data integrity practices, regulatory agencies around the world are focusing on the application of principles and practices to ensure product quality and patient safety.
What does Data Integrity mean?
According to guidance issued by regulators, data integrity is defined as the extent to which all data is complete, consistent and accurate throughout the data lifecycle. Data Integrity requirements include that they are Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). In addition to the main ALCOA requirements data must be Complete, Consistent, Enduring, and Available : the whole is usually referred to as ALCOA+.
What are the Data Integrity guidelines?
The growing issues of data integrity across life science companies means that organizations need to be able to adapt rapidly to prevent violations and regulatory consequences. Several guidelines have been developed to help companies building a efficient Data Integrity program :
- Considerations for a Corporate Data Integrity Program – ISPE
- GAMP® Guide: Records & Data Integrity – ISPE
- EMA GMP Data Integrity Guidance
- Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry – FDA
- Current expectations and Guidance, including Data Integrity and Compliance with cGMP – FDA
- PIC/S PI 041-1 – Good practices for data management and integrity in regulated GMP/GDP environments
Need someone to audit your processes with regards to Data Integrity ? Or want to find a Data Integrity expert ?
When implementing a programme to identify, develop, review and improve data integrity across an organization, you need to find the right experts in the domain. And you’ve most certainly come to the right place. At Akility, you can find the expert to help you analysing, evaluating, auditing or running Data Integrity program.
