Auditing software targets FDA chemical validation

By Simon Pitman

- Last updated on GMT

Related tags Chemical industry Fda

Valdata Systems has devised a software validation system aimed at helping chemical companies meet the challenge of fulfilling auditing regulations.

Fine chemicals and related ingredients players an integral part in the formulation of cosmetic and personal care products, and likewise, ensuring that all such products meet regulation and auditing requirements is crucial.

In particular the US market for chemicals is regulated by FDA audits. If companies trading in this area do not meet current FDA auditing requirements, then, in short, they cannot do business in the US market.

Software aims to help make companies more organized

In response to this challenge, Valdata has come up with Chemical Management System, a software designed to help companies manufacturing chemical-related products to be more organized in this often convoluted and complex process.

The system offers real-time, paperless control over all the primary manufacturing processes, including, formulation development, receiving, testing, inventory control and pre-weigh, as well as providing an overview of the manufacturing and production processes.

The software has been designed to meet the strictest processes, which the company says includes FDA’s CFR 21 Part 11, and is precise enough to provide an audit trail that details every single transaction.

Designed to eliminate human error

Likewise, the system communicates directly with scales, so all pre-weigh and consumption data is guaranteed to be accurate and eliminate human error, the company also claims.

The individual operating the software is also prompted at every level of the auditing procedure, an element that aims to help eliminate human error and ensure that no detail is forgotten.

The company says it has already implemented the system with a handful of leading players involved in the fine chemical and ingredients area, including BioPharm International and CEI, both of which have operations in New Jersey, where Valdata is also based.

Related topics Formulation & Science

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