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

2. EffiChem
We help ISO 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 accredited & GMP labs.

3. 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 Institutions countries
EffiChem 4.0 available in Polish

4. 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

5. Ease of Use

6. Similar Interface Makes Adoption Faster
„Samples”
„Equipment”

7. Statistical Data Evaluation - Method Validation - Uncertainties - Control Charts

8. Method Validation

9. Methods module on the Dashboard

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

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

12. Uncertainties

13. Uncertainties

14. Uncertainties

15. Laboratory Management Quality Management

16. Example: Samples Module
Click Samples on the dashboard

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

18. Sample Results
Underlying Results

19. Enter or edit individual Results
Results Entry
Enter or edit individual Results

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

21. Benefits for the Lab

22. Benefits: Less Risk, Data Integrity

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

24. 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

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

26. Thank you!
Questions?