Data integrity: sharing results regulators can trust

In a highly informative and useful Expert View piece, Heather Longden, senior marketing manager for informatics regulatory compliance at the analytical laboratory instrument and software company Waters Corporation, provides insights into the vital role data integrity plays when it comes to analytical testing for drug development.

More drugs are being developed and manufactured in more laboratories around the world than ever before. This has placed a greater burden on regulators all over the world to ensure drugs manufactured by different companies adhere to uniform standards of quality and safety. As a result, regulators have increased their scrutiny of drug submissions and drug product release data for compliance with current good manufacturing and good laboratory practices.

Manufacturers have to provide regulators with full accountings of high-quality data to prove integrity of their products. This reliance on data is perhaps best illustrated at the US Food & Drug Administration (FDA), where they once lived by the quotation from W Edwards Deming (the father of modern quality management): “In God we trust. All others bring data.”