Compliance reduces regulatory risk and allows you to concentrate on your critical science. The validity of your analytical results depends on many factors, but for laboratories in regulated industries, there is a particular focus on two areas: The analytical instrument must be qualified for intended use, and the software must be validated for intended use.

If these requirements are not satisfied, questions may arise during audits and inspections that can jeopardize confidence in the integrity of your analytical results. Even worse, they can raise concerns about the data already supplied to regulatory agencies, as well as the quality of your products.

When surveyed, 84% of laboratories classify data integrity as “very” or “extremely” important. This attitude is not surprising, because regulators are now looking at all laboratory operations—including analytical instrument qualification—from a data integrity perspective.

In this era of evolving data integrity focus, FDA 483 reports demonstrate that laboratories are being cited because their controls do not prevent data manipulation. See how your lab can protect itself from citation.

Regulated laboratories must demonstrate that analytical instruments are suitable for their intended use. U.S. Pharmacopeia general chapter <1058> (analytical instrument qualification (AIQ)) defines the essential framework that your lab should follow.

As the only major pharmacopeia with a general chapter dedicated to AIQ, USP <1058> is a key regulator reference and changes have global implications for instrument qualification

The regulatory focus on data integrity is driving many laboratories to upgrade their analytical technologies and software applications to ensure that they can; benefit from new functionality/key features, decrease reliance on manual/paper-based workflows, enhance security, and increase automation.

The regulatory requirements to validate software for intended use within the lab can represent a significant compliance workload. Unless addressed, this workload is a potential barrier to labs upgrading or implementing new software