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					Micro Control Solutions
 Annual Product Review rev. 6.5




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Interactive Modular Design




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Admin. Level Application Settings
               21CFR Part 11


                                          • application lockout timing
                                                   • separate setting for data
                                          • application logoff timing
                                          • password confirmation request for edits
                                          • define access attempts
                                          • define login display
                                          • define password aging cycle




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Admin. Level User Access Settings
               21CFR Part 11


                                          • individually assign a user’s application access
                                          • define manufacturing user access
                                          • define QC user access
                                          • define data merging default




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Admin. Level Application Settings
           Multi-level audit logs
                                          • application event logs




                                           • application access logs




                                              • product and specification library
                                              edit logs




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Library and Dictionary Templates
                                          • product templates
                                                  • name
                                                  • description
                                                  • expiration
                                                  • review period
                                                  • batch sizes



                                          • parameter templates
                                                 • tests
                                                 • limits
                                                 • precision
                                                 • # of entries
                                                 • laboratory preference
                                                 • alert limits
                                                 • multiple data entry options

                                          • define equipment “types” used
                                          during product


                                          • define the formulation and
                                          packaging components to track




                                          • define manufacturing sites




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System Dictionaries
            “point and click entry”
• equipment dictionary




                         • abbreviation dictionary




                                • analyst dictionary




                                                       • “quick select” dictionary




                                                                          as typical examples...




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Track Returned Goods
      “point and click entry”
    • select your product template



                            • enter retuned goods information using “point and click”
                            dictionary options or type in required information




                                                • filter the returned goods database using
                                                multiple criteria options




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Track Customer Complaints
        “point and click entry”
      • select your product template



                                       • enter customer complaint information using “point and
                                       click” dictionary options or type in required information




                                            • filter the customer complaints database
                                            using multiple criteria options




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Track Product Investigations
         “point and click entry”
       • select your product template



                      • enter investigation information using “point and click”
                      dictionary options or type in required information
                               • attach external documents to the entry.
                                        • Word®, Excel®, or PDF




                                                              • enter corrective action and date to
                                                              be completed



                                                                              • filter the investigations
                                                                              database using multiple
                                                                              criteria options




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Data Handling and Review
      • select your product template



               • enter lot particulars:
                        • lot #
                        • mfg., release, and fill dates
                        • auto calculates the expiration
                        • batch size
                        • site information
                        • sales




                                                           • track the raw materials used in the
                                                           manufacturing process




                                                                                 • track the equipment
                                                                                 used in the manufacturing
                                                                                 process




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Data Handling and Review
           • enter results for each required test
                    • out of spec results highlighted in red
                    • out of alert results highlighted in blue
                    • add comments
                    • specifications at the time of the test are
                    recorded and stored
                    • add reference information




                               • selectively lock access so only those with
                               proper authorization can access designated
                               data entry areas.


                                                    • approval process for temporary data
                                                               • data approval locks all temporary data
                                                               editing functions




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Reporting Functions
                                   • multiple reporting options
                                            • summary reports
                                              • define the report content
                                              • certificate of analysis report
                                                         • define C of A parameters
                                              • reports by parameter
                                              • “individual results” format
                                              • cover page
                                              • define the report layout
                                              • define print order
                                              • add/remove tests from the
                                              report
                                              • print:
                                                  • tables
                                                  • logs




                                           • graphics reports
                                               • parameter charts
                                                        • spec changes displayed
                                              • parameter overlays
                                                        • 2 y-axis display
                                              • control charting
                                              • hi-lo charts




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                Micro Control Solutions
                     Annual Product Review rev. 6.5

• Our annual product review software is a Part 11 compliant package

• Capable of monitoring a full scale production environment

• Validation services available

• On site training

• Visit us at: www.microcontrolsolutions.com

• Contact us at: newCustomerInformation@microcontrolsolutions.com




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posted:10/4/2012
language:English
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