EffiChem Presentation Vitezslav Centner PQP Conference, Tehran, 30 OCT 2016

EffiChem We help ISO 17025 accredited laboratories and pharmaceutical/petroleum industries to ensure regulatory compliance and efficient lab operation by delivering quality systems and laboratory management software that provides control and transparency through the entire quality processes. The only Laboratory Information & Quality Management Software integrating Method Validation and Part 11 record keeping for ISO 17025-accredited & GMP labs.

History and References 2012 |New Features 1999 |Development and Release 2004 |Adoption in Europe 2015 |Version 4.0 EffiChem 4.0 Flexibility and configuration. 1080+ Users 450+ Institutions 32 countries EffiChem 4.0 available in Polish

Scope Quality Laboratory LIMS STATISTICS Compliant Software QMS SW validation and GAMP FDA Part 11 Record-Keeping Data Integrity Quality Method Validation Uncertainties Control Charts Laboratory LIMS STATISTICS Compliant Software QMS

Ease of Use

Similar Interface Makes Adoption Faster „Samples” „Equipment”

Statistical Data Evaluation - Method Validation - Uncertainties - Control Charts

Method Validation

Methods module on the Dashboard

Example: Validation Parameters - Linearity To assess validation parameter LINEARITY: Click “+” in front of the method number Click Analyte name to assess (DEMO.PARAMETR.000001) Click “Validation” Click “Full validation” Click “Linearity” Click “Correlation coefficient”

Validation Parameters: Linearity „Data“ tab „Chart“ tab „Report“ tab

Uncertainties

Uncertainties

Uncertainties

Laboratory Management Quality Management

Example: Samples Module Click Samples on the dashboard

Example: Samples Module Module Menu: Search, Trends, Master Data Each line represents one Sample

Sample Results Underlying Results

Enter or edit individual Results Results Entry Enter or edit individual Results

More Than Samples – All Linkable Risk Analysis Observations Reference Standards Equipment Training

Benefits for the Lab

Benefits: Less Risk, Data Integrity

Additional Benefits Flexibility All-in-One (configuration) Support and Know-how Quality-Cost-Time

An ROI Example – Method Validation Average duration of one method validation study: 200 Hours Lab hourly rate: $40 USD Validation studies per year: 10 Estimated Savings: Time saving per method validation study: 40 Hours/Validation Cost saving per method validation study: $1,600 USD/Validation Yearly time saving in method validation: 400 Hours/Year Yearly cost saving in method validation: $16,000 USD/Year Note: The estimated saving is based on the assumption that data evaluation and validation reporting represents 40% of the overall method validation time which can be cut roughly in half by using EffiValidation. Projected ROI     EffiValidation investment cost: $2,490 Projected ROI for this upgrade: 1.8 Months 50% saved 20% saved ROI: 1.8 Months

Implementation Procedure Project Definition: Goal and Scope User Requirements Specification Configuration TRIAL Version Installation and Testing Freeze Final Configuration Software Validation Training Go Live

Thank you! www.effichem.com Questions?