Release 11 - The Standard for Quality Assurance software designed to evaluate and measure the clinical laboratory performance and provide clear, concise, 'inspector-ready' reports to meet all CLIA '88, CAP, JCAHO  and COFRAC requirements.  EP Evaluator® was designed by a board-certified clinical chemist specifically to meet the needs of the clinical laboratory and is used by more laboratories and more invitro diagnostics (IVD) companies than any other software of its kind. 

Additional Information



Version Comparisons


Regulatory Requirements

EP Evaluator® Versions

   Accuracy and Linearity                  
         Clinical Linearity, Calibration Verification and
              Reportable Range                               
   check mark check mark  check mark check mark  
         Simple Accuracy    question mark     check mark check mark      
         CLSI EP6 Linearity   question mark          
         Trueness   question mark          
   Method Comparison                                        
         Alternate (Routine Quantitative)    question mark  check mark check mark check mark check mark
         CLSI EP9 Method Comparison    question mark            
         Two Instrument Comparison       check mark   check mark check mark check mark
         Multiple Instrument Comparison   check mark   check mark check mark check mark  
         Qualitative / Semi-Quantitative  check mark  check mark check mark check mark  
         POC Glucose  check mark            
         Hematology Studies  question mark   check mark check mark      
         Simple Precision  check mark check mark check mark check mark check mark
         CLSI EP5 Precision  check mark            
   Reference Interval                           
         Establish   check mark check mark check mark check mark check mark  
         Verify   check mark check mark check mark check mark check mark
         ROC Plots   check mark          
         Limits of Blank (Analytical) *   check mark check mark   check mark  
         Limits of Quantitation (Functional) *   check mark          
   Lab Management                
         Cost Per Test   check mark            
         Incident Tracking   check mark            
         Inventory Management   Inventory Management: Provides for tracking receipt and dispensation of laboratory supplies.            
         Competency Assessment   Competency Assessment will provide for assessing competency through asking questions and tracking various measures of competency assessment for individuals.            
         Geometric Mean and VRI   Geometric Mean and VRI: Calculates geometric mean and verifies reference interval for PT and INR results.    check mark  check mark      
         PT/INR Method Comparison   Method Comparison: Compares both PT and INR for two methods.    check mark check mark       
         Manual INR Check   Manual INR Check: Validates the INR calculation.    check mark      
         Factor Sensitivity (FS)  Manual INR Check: Validates the INR calculation.                
         Performance Standards (TEa)   Performance Standards (TEa): Calculates total allowable error from several different criteria.            
         Carryover   Carryover: Calculates specimen to specimen carryover.       check mark
         CLSI EP10 - Preliminary Evaluation  CLSI EP10 - Preliminary Evaluation: Determines linearity, precision, accuracy, carryover and drift, using 50 results assayed over 5 days.      
         Interference (CLSI EP7) *  Interference (CLSI EP7): Determines maximum concentration of a specimen interferent that will produce a clinically acceptable result. check mark    
         Six Sigma Metrics  Six Sigma Metrics: Determines if method meets criteria for Six Sigma performance using bias and precision statistics.            
         Average of Normals (Checks Bias)  Average of Normals: Tracks median value of all patient results in order to detect changes in method bias.            
         Stability  Stability:  Assesses the stability of specimens or reagents over time in a specified storage condition.       check mark  
         Histogram and Descriptive Stats  Histogram and Descriptive Stats: Calculates a variety of statistical parameters for a dataset that describe the mean (or central tendency) and SD (dispersion).            
   Additional Features                
         Composite Reporting  Data Extraction from Instrument Manager™: Capability of extracting data directly from instrument Manager via ODBC directly into many EE modules.          
         Data Extraction from Middleware  Data Extraction from Instrument Manager™: Capability of extracting data directly from instrument Manager via ODBC directly into many EE modules.              
         Project Management  Project Management: Implements ability to create and manage unlimited new projects and to archive old data.            
         Audit Trail and Network Security  DAudit Trail and Network Security: “Professional Version” Features that satisfy 21 CFR Part 11 regulations for audit trail, and limits program or project access via password protection to authorized users.              

  Required by regulatory legislation or organization   Optional by regulatory legislation or organization
Items in red indicate changes in EE Release 11
   * Evidence can be provided from vendor or laboratory


Implements Eight CLSI Protocols

  • EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline
  • EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
  • EP9-A, Method Comparison and Bias Estimation using Patient Samples; Approved Guideline
  • EP12-A, User Protocol for Evaluation of Qualitative Test Performance--Approved Guideline
  • C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline
  • GP10-A, Assessment of the Clinical Accuracy of Laboratory Tests using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
  • EP10-A, Preliminary Evaluation of Clinical Chemistry Methods; Approved Guideline
  • EP7-A, Interference Testing in Clinical Chemistry--Approved Guideline


System Requirements 

  Operating System

Windows 7
Windows 8.1 (validated for EE 11.2 and above)
2008 Server
2012 Server

   Memory A minimum of 128 MB of RAM for the application
   Hard Disk

Minimum of 200 MB for non-network, single user implement
Minimum of 1 GB for networked, multi-user  implementation


Monitor (1024 x 768 minimum resolution), Keyboard, Mouse and
local or networked Printer
Adobe Acrobat Reader or compatible program