The only application used by Pharma companies worldwide for over 2 decades
At the heart of the application is a validated residue limit calculation engine that has been in use for the last 2 decades. Designed by Destin LeBlanc, this calculation engine has been verified by more than 100 sites worldwide, some involving 500 products in a single calculation. eResidue has passed multiple FDA, MHRA, EMA, ANVISA & other regulatory inspections. It addresses both chemical & microbial residues in alignment with ISPE Cleaning Validation Guide and PDA Technical Report 29.
eResidue Pro has been designed to address all cleaning validation requirements at a site. Cleaning studies, limit calculation, worst case product determination, impact analysis, line clearance, execution of cleaning work instructions, sample collection, capturing residue results and finally data analysis – all can be carried out seamlessly from within the application. eResidue Pro can also be integrated with your SAP, LIMS, QMS and Document Management systems working towards a paperless work place.
Our business is Cleaning Validation. Quascenta offers separate eResiduePro solutions for API, Formulation or Biotech manufacturing. Utilise our expertise in cleaning validation to set up an audit ready compliant CV program. Our SMEs can configure the application to meet your unique cleaning requirements. Our project team can also help you with qualification script execution, data verification and data upload. You can also out-source your entire CV program to Quascenta.