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Overview
eResidue Pro is a validated, cloud-based application for pharmaceutical cleaning validation and residue limit calculation, automating the full lifecycle from design to line clearance. It ensures compliance and replaces inefficient spreadsheets. While highly specialized for regulated industries, its modular design enables seamless scalability across API, biotech, and formulation sites.
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Starting Price
Custom
eResidue Specifications
Quality Control
Compliance Management
Document Management
Reporting And Analytics
What Is eResidue?
eResidue is a validated, cloud-based software designed and supported by Quascenta, specifically for the pharmaceutical industries. It serves as an all-in-one platform to manage the entire cleaning validation (CV) program lifecycle for manufacturing equipment. Its core function is a solid, calculation engine developed by industry expert Destin LeBlanc, which accurately determines residue limits such as Maximum Allowable Carry Over (MACO) based on toxicity or drug dose. The software eliminates paper-based trails, ensures audit readiness, and enforces compliance with global regulatory standards like FDA 21 CFR Part 11.
eResidue Pricing
eResidue pricing is customized and based on user needs and requirements.
eResidue Integrations
eResidue Pro is designed for seamless data integration across the manufacturing and quality enterprise to achieve a paperless workflow.
Who Is eResidue For?
eResidue is ideal for the following industries:
- Pharmaceutical
Is eResidue Right For You?
eResidue Pro is an industry-validated solution, perfect for pharmaceutical and biotech companies seeking to replace inefficient, risky spreadsheet-based residue calculations with a robust, 21 CFR Part 11 compliant application. Having successfully passed multiple major regulatory inspections (FDA, EMA, MHRA), it offers peace of mind regarding audit readiness. Its closed-loop system manages the entire validation lifecycle, from limit calculation to line clearance, all while being a HIPAA Compliant cloud application. If your priority is achieving proactive regulatory compliance and faster computation for residue limits, eResidue Pro offers deep specialization that generic systems cannot match.
Still not sure about eResidue? Contact our support team at (661) 384-7070 for further guidance.
eResidue Features
eResidue features a tested and validated calculation engine to enforce residue limits with precision. It handles all manufacturing scenarios and can generate accurate residue limit reports in minutes, based on MAC, lower drug doses, or health and hygiene criteria.
eResidue is the only application that can track the cleaning process from the end of manufacturing through cleaning all the way to line clearance. This ensures a complete, single source of truth for the entire equipment lifecycle.
The application seamlessly maintains a 21 CFR Part 11 compliant audit trail to remove stress from regulatory inspections. Security features include encrypted data, firewalls, and role-based access management to ensure secure data both at rest and in motion.
The application constantly tracks the validation status of all equipment and product pairs, including indirect and non-product contact surfaces. It visually highlights any item that has not been validated in red, ensuring sites immediately know what to prioritize next to maintain compliance.
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