Book demo

eResidue Pro for
Biologics & Vaccines

A cleaning validation software application just for large molecules

Book demo

Still relying on WFI specification for your residue limit? Wondering how to increase your limit? eResidue Pro tracks all your direct product contact equipment through the cleaning validation process and beyond – shrinking your workload and ensuring your site remains compliant.

Complete Software

Only application that can track cleaning process from end of manufacturing through cleaning all the way to line clearance.

Calculation Engine

Validated calculation engine that handles all scenarios / manufacturing site type.

Easy to use

Our platform features a simple dashboard, flat UI design, and easy-to-understand tools to make data analysis a breeze.

Accessible

eResidue Pro is an entirely cloud-based application, meaning there’s no software to install and you can access it anywhere, anytime.

Accurate

Built on a tested residue limit calculation engine, eResidue Pro can generate residue limit reports in minutes.

Secure

Role-based access, password management, centralized control, firewall and encrypted data both at rest and in motion are just some of the steps

Compliance
Made Easy

Our purpose-built platform has helped pharmaceutical companies big and small migrate away from inefficient, spreadsheet-based limit calculation matrices. eResidue Pro is an all-in-one application that tracks the lifecycle of your products and equipment throughout the entire cleaning validation program.

Calculate Residue Limits with Confidence

eResidue Pro enforces residue limits with razor-sharp precision while providing you with the flexibility to make calculations based on the 10 parts per million MAC, lower drug doses, or health and hygiene reasons alone. Our matrix provides a full overview of the product pairs contributing to lower residue limits.

Ensure No Equipment or Product is Left Behind

With eResidue Pro, there’s no need to worry about unvalidated equipment or products. The application constantly tracks their status, highlighting anything that has not been validated in red and placing it at the top of the item list so you know what to prioritize next.

Track Multiple Product Contact Surfaces

Many warning letters highlight the need to sample indirect and non-product contact surfaces. eResidue Pro does just that.

Harness a Complete Solution

eResidue Pro is the only application that allows sites to track the entire lifecycle of their equipment, from line clearance and production to cleaning validation and equipment release, with just one application.

Be Ready for Audits

Seamlessly maintain an audit trail that’s 21 CFR Part 11 compliant to remove the stress from inspections and ensure you never fall foul of regulators.

Plug Your Cleaning
Validation Bottlenecks

With eResidue Pro, you can both simplify your cleaning validation policy and boost productivity.

That means waving goodbye to:

  • Resources wasted on tedious residue limit spreadsheets
  • Struggles tracking the cleaning validation status of equipment
  • Endless paper-based trails of everything from sampling reports to residue levels
  • Capturing cleaning work instructions on paper
  • Complex and stressful cleaning validation strategies

Software You can Trust

eResidue Pro is the only cleaning validation application that has passed multiple FDA, EMA, MHRA, ANVISA, and other regulatory inspections. It’s also compliant with:

HIPAA

21 CFR Part 11 and Annex 11 requirements

GAMP5

ISPE Cleaning Validation Guide

PDA Technical Report 29

100+

customers worldwide

20+

years in use by companies

With a legacy spanning over 20 years, eResidue Pro by Quascenta is the longest-standing cleaning validation application in existence. Our software has been a market leader in the pharmaceutical industry since 2004, helping firms digitalize their cleaning validation processes and embrace a program that regulators have seen successfully deployed time and again

Biotech

Formulation

API

Cosmetic

Quascenta is home to multiple cleaning validation SMEs, the most famous being Destin LeBlanc. Together, they’ve poured all their industry knowledge and experience into eResidue Pro, which is why it features a modular and scalable design that adapts to your site requirements – be it API manufacturing, biotech, formulation or cosmetic – without the need for any software customization.

Read more