Pharmaceutical cleaning validation simplified with new software
Digital Journal: The company Quascenta has simplified cleaning validation for active pharmaceutical ingredient manufacturers through a new software package called eResidue. Cleaning validation is a key process, and it avoids cross-contamination.
The main purpose of Quascenta's recently launched software application – eResidue – is to replace spreadsheets. Spreadsheets require manual input; they can suffer from calculation errors and there are concerns about data integrity, especially from the regulators of the pharmaceutical sector like the U.S. Food and Drug Administration (FDA). The new software package also allows manufacturers to eliminate costly errors and to save time. Cleaning validation is a key concern in the pharmaceutical sector and the new software has been evaluated by cleaning expert Destin LeBlanc, who has developed the industry’s cleaning validation standards via the Parenteral Drug Association (PDA). Quascenta develops IoT solutions, primarily aimed at the perishable goods industry. The software solutions allow companies to monitor, on a real time basis, their products and take instant action. The primary aim of the eResidue program is to improve the way pharmaceutical manufacturers track important production information, such as residue limits and worst case molecules. The software allows for complex computations to take place, including factoring in intermediates, cleaning agents and other residues.
Each assessment undertaken with the software will be unique to each facility, taking into account different manufacturing environments. The software will also store all equipment and product-related data; overall it offers a digital transformation package for manufacturers to address cleaning validation concerns. The new software also meets industry regulations pertaining to compliant audit trails and electronic signatures, standard and customized reporting.
