Watch On Demand: Data Integrity and Compliance Seminar

Accuracy is the principal factor in the results in a laboratory, and precision measurement ensures that nothing is left to guesswork. Data integrity is making sure that the accuracy and consistency of the data are maintained over its entire life cycle. Furthermore, this is crucial in the pharmaceutical industry to ensure that the end products meet all required quality standards. Violations of data integrity have led to severe regulatory actions, import alerts, consent decrees and fines. The World Health Organization Data integrity guidance states that data integrity risks are higher when processes are manual or paper-based. 

Danielle Aridis-Lang, Applications Specialist for Lab Weighing at Sartorius Australia, discusses compliance and connectivity to eliminate the risks to data integrity. 

The presentation covers the following topics:

• How to comply with data integrity requirements by following the ALCOA principles 
• Reporting responsibilities according to CFR21 Part 11 requirements