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 21 CFR 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 different approaches for each setup. Subscribe based on your current requirements. Upgrade anytime if your need changes.
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 Admin. 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 immediate access. Simple dashboards and flat UI design help you analyse information fast.
Structured Search
Powerful visualization and data-mining features 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.
- ANVISA GMP, RDC 301/19, 2019, Brazilian Health Agency
- Health Canada, “Good Manufacturing Practices Guide for Drug Products.”, GUI-0001, 01st October 2018.
- Health Canada: Cleaning Validation Guidelines GUIDE-0028, January 2008
- China GMP, National Medical Products Administration (NMPA), 2011.
- European Commission EudraLex, Vol. 4, “Good Manufacturing Practice (GMP) guidelines.”, Directives 91/356/EEC, Amendments 2003/94/EC, 91/412/EEC, Annex 15, European Medicines Agency (EMA)
- EMA Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities, 2014, EMA/CHMP/CVMP/SWP/169430/2012, European Medicines Agency (EMA)
- EMA Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’, 2018, (EMA/CHMP/CVMP/SWP/169430/2012), European Medicines Agency (EMA)
- ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – Q7, 2000, International Council for Harmonisation (ICH)
- ICH Harmonised Tripartite Guideline, Quality Risk Management – Q9, 2005, International Council for Harmonisation (ICH)
- Ministry of Health, Labour and Welfare, MHLW Ministerial Ordinance No. 179, 2004, “Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs.”, (Japanese GMP Ordinance).
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Annex 15: Qualification and Validation, PE 009-14, July 2018, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- PIC/S Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation, PI 006-3, September 2007, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- PIC/S Aide Memoire: Cross Contamination in Shared Facilities, PI 043-1, July 2018, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- PIC/S Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities, PI 046-1, July 2018, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- PIC/S Aide Memoire: Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management, PI 052-1, June 2020, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- PIC/S Questions and Answers on Implementation of Risk-Based Prevention of Cross-Contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’, PI 053-1, June 2020, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- United States FDA “Validation of Cleaning Processes,” Guide to Inspections Validation of Cleaning Processes, 1993, US Food and Drug Administration (FDA)
- United States Code of Federal Regulations Title 21, Chapter I, Part 210, “Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs: General”.
- United States Code of Federal Regulations Title 21, Chapter I, Part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals”.
- FDA Guidance for Industry: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Questions and Answers, April 2018, US Food and Drug Administration (FDA)
- WHO Technical Report Series, No. 957, Annex 2 WHO good manufacturing practices for active pharmaceutical ingredients, World Health Organization (WHO), 2010
eResidue Pro design has also taken inputs from cleaning validation guides by industry bodies.
- PDA Technical Report No. 29, Points to Consider for Cleaning Validation
- PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation
- ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls
- ASTM E3106-18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
- APIC Guidance on Aspects of Cleaning Validation in API Plants are some of the documents that would mirror the workflow in eResidue, 2016, Active Pharmaceutical Ingredients Committee
