Quascenta Simplifies Cleaning Validation For Active Pharmaceutical Ingredient (API) Manufacturers With The Release Of Eresidue Software
Biospace: Quascenta's just launched software application eResidue for API replaces manual spreadsheets; thereby allowing the Active Pharmaceutical Ingredient (API) manufacturers to streamline their residue limit calculations, eliminate costly errors, and save time.
Quascenta is pleased to announce the official release of eResidue-API, a software application designed specifically to help the Active Pharmaceutical Ingredient (API) manufacturers with a more efficient, affordable and compliant cleaning validation process. The first product of its kind, eResidue will significantly improve the way manufacturers set the residue limits and identify the worst case molecule.
Over the years, the API manufacturers have been relying solely on the traditional practice of using spreadsheets and calculators for residue limit calculation. However, it has been observed that this process is both time-consuming and error prone. More importantly, this process fails to relate the intermediates, cleaning agents and other residues to the APIs.
Quascenta claims that eResidue for API will bridge the gap in the residue limit calculation process by providing a software platform that not only stores all equipment and product related data, but also allows users to carry out multiple calculations based on their site requirements. The application has been designed to handle complex workflows while providing a simple user interface.
Quascenta has developed eResidue for API in collaboration with Destin LeBlanc. Destin is the chair of the PDA task force to revise and update PDA Technical Report #29, and an internationally recognized expert in the area of cleaning and cleaning validation.
eResidue-API has been built on the existing eResidue – a powerful and intuitively designed cleaning validation software application for finished pharmaceutical products. It offers several critical features that include the ability to use dose or health based values as the basis, role-based access, 21 CFR Part 11 compliant audit trails and electronic signatures, standard and customized reporting, and more.
“eResidue for API is the first and only solution for cleaning validation residue limit determination designed around the requirements of API manufacturers”, commented Ravi Moorthy, President of Quascenta. “Our customers can finish the qualification and start using the application within a week, without lengthy implementation cycles that are typical in desktop based applications.”
To find out more about eResidue for API or request an online demo, please visit https://www.eresidue.com/arrange-demo About Quascenta: Quascenta Pte Ltd. is a specialty solutions provider to the healthcare industry. The company is developing novel software and hardware solutions to bring about a change in the way data is captured and analysed, thereby improving operational efficiency. Quascenta’s flagship solution, eResidue®, is currently in use at several locations worldwide.
About eResidue: Developed by Quascenta in collaboration with Destin LeBlanc, eResidue is a validated cleaning validation software. Its available in 2 versions, one for API and the other for finished drug products. This first-of-its-kind software application will help improve the residue limit calculation process by efficiently storing all relevant data and carrying out multiple calculations as per the requirement of the manufacturers.
