Cleaning Validation Simplified®

eResidue Pro by Quascenta


  • Are you spending a lot of time in calculating residue limits?
  • Are you worried that your calculation may have errors?
  • Are you facing trouble in tracking your equipment validation status?
  • Are you tracking cleaning sampling and sample collection on paper?
  • Are you able to easily access and trace your cleaning validation data?
  • Are you unsure about your cleaning validation strategy?

Why eResidue Pro?

eResidue Pro by Quascenta can assist you in maintaining a compliant cleaning validation programme. The software seamlessly integrates all the cleaning validation data under a single umbrella thereby improving not only productivity but also acts as an aid in better decision making from the integrated data available on demand.


Proven Track Record

eResidue Pro by Quascenta is a mature product that has been in use since 2004. With over 100 customers across the globe, eResidue Pro is undoubtedly the market leader. It is the only cleaning validation application that has passed multiple FDA, EMA, MHRA, ANVISA & other regulatory inspections.


Industry Driven Design Specific to Cleaning Validation

Designed by Destin LeBlanc, eResidue Pro has been built on collective inputs from our worldwide customer base. It is an application designed specifically for cleaning validation.


CSV Regulation Driven

Robust, validated, pharma specific solution developed as per GAMP5 that meets 21CFR Part 11 and Annex 11 requirements. A secure date and time-stamped audit trail, role-based access, password management and centralized control are not only enforced within the application but also for the associated infrastructure. Once a calculation is over, the application takes care of routing, delivery, and notification while ensuring that a draft copy is only available for review. Electronic signature and dual authentication meet 21 CFR Part 11 requirements.


Closed Loop Cleaning Validation System

eResidue Pro covers the entire cleaning validation lifecycle from cleaning process design to ongoing monitoring.


Quality Compliance Simplified

Automated workflows, built-in best practices and seamlessly connected processes ensure proactive compliance.


Rapid Time-To-Value

Ready-to-use, modular and scalable cloud application accelerates deployment with a short validation timeline and minimal expense.


Modular and Scalable

Finished Drug Facility, API or Biotech, eResidue Pro’s modular design allows for different approaches for each setup. Subscribe based on your current requirements. Upgrade mid-year if your requirements have changed or increased.


Secure – HIPAA Compliant

eResidue Pro is HIPAA Compliant. Your data is safe with us. Not just that! All changes made within eResidue can be monitored by your Admins’. The application logs the type of change and the person who made the change along with a date and time stamp. Therefore, your data is safe from the outside as well as from the inside.


Ease of Use and Effortless Reporting

While eResidue Pro recommends a paperless workflow, reports can be downloaded for all actions. All calculations are saved in the application as PDF reports allowing for immediate access. Simple dashboards and flat UI design allow you to access and analyse information fast.


Structured Search

Powerful visualization and data-mining capabilities built into eResidue Pro allows for quick insight into any equipment or product.


Faster Computation Power

Carry out calculations involving up to 500 products in minutes rather than hours.


Cloud-Based

Zero footprint. No software to install. Accessible from anywhere.


Simplifying Proof of Compliance

Regulatory requirements are updated from time to time!

eResidue Pro makes sure that all compliance requirements related to cleaning validation are met and updated in a timely manner.   Following are some of the regulatory requirements on which eResidue Pro has been built.

 

eResidue Pro design has also taken inputs from cleaning validation guides by industry bodies.