Associate Director Global Quality
1. How fundamental is the role of Data integrity in the context of Quality control?
The integrity of data has always been a critical aspect of quality control. Everything that QC does requires the meticulous recording of data and maintaining that data in QC records. This has occurred for over 5000 years from the initial scientific recordings on papyrus in Egypt through Da Vinci’s scientific notebooks up to the an analyst’s laboratory notebook today. The challenge facing Quality Control today is the transformation from a predominantly paper-based system with its well-developed review system to an electronic data system. The benefits of computerized systems has increased laboratory efficiency and productivity but their complexity has increased the scope of what is required to maintain the integrity of data.
2. Why do you think Pharmaceutical companies should pay special attention to Data integrity in 2017 and upcoming years?
The concerns of the Regulatory Authorities continue with 79% of warning letters from the FDA citing Data Integrity. For the last decade perhaps there was too much focus on computer system validation and misunderstanding regarding what was a the primary record; paper or electronic. As lab processes became more electronic I believe a sense of loss of ownership occurred regarding data records... was it now IT’s or QC’s? This is why identifying the business data life cycle coupled with an ICH Q9 risk assessment is the area that companies need to pay particular attention.
3. What are, in your opinion, the top three priorities to keep data integrity?
Computer system validation remains the foundation of data integrity for electronic based processes. A good CSV package indicates that consideration has been taken with regard to the technical controls and procedures to ensure data integrity. The other two priorities are increased governance by management which will then lead to better employee engagement. Even small steps by management in promoting data integrity will have a significant positive effect as employees will give greater consideration if they are faced with an issue. A management strategy of employee engagement in data integrity will increase process ownership by employees and promote a continuous cycle of data integrity improvement.
4. Any final thoughts on Data Integrity?
People have been breaking the rules from the start of time so technical and procedural controls are only part of the answer. You need to ask why would someone circumvent controls or modify data. Identify the “Why.”