Micro Control Solutions Stability System II rev 6

Micro Control Solutions Stability System II rev. 6. 5 Move to the next slide when the request appears www. microcontrolsolutions. com “Click” for next slide

Interactive Modular Design • displayed alert for sample pull • displayed alert for testing initiation • displayed alert for testing completion • click on an alert to see the samples in the category • use the “Quick Call” function for instant study access • scan a bar code or enter the study ID # to initiate the function www. microcontrolsolutions. com “Click” for next slide

Admin. Level Application Settings 21 CFR 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 • define inventory pull alert and email • define test initiation alert and email • define test completion alert and email • define approval levels for specifications, study login, and data review. • email alerts for seamless notifications for processes to be completed. www. microcontrolsolutions. com “Click” for next slide

Admin. Level User Access Settings 21 CFR Part 11 • individually assign a user’s application access or. . . • assign them to one of 5 custom designed user groups • add e-signature for signing summary reports or C of A reports • define applications and default locations for documents that can be “attached” to individual studies for instant recall. PDF, Word and Excel auto located. www. microcontrolsolutions. com “Click” for next slide

Admin. Level Application Settings Multi-level audit logs • application event logs • application access logs • study and specification library edit logs www. microcontrolsolutions. com “Click” for next slide

Library and Dictionary Templates • product templates • tests • limits • precision • # of entries • laboratory preference • alert & variance limits • test library selection option • define multiple testing matrixes • define default inventory requests by interval www. microcontrolsolutions. com “Click” for next slide

System Dictionaries “point and click entry” • packaging components • fills • containers • closures • liners • seals • resins • manufacturers • more. . . • study conditions • reason for study • storage location • mfg. and packaging sites as typical examples. . . www. microcontrolsolutions. com “Click” for next slide

Initiate a Study “point and click entry” • select your product template • enter study information using “point and click” dictionary options or type in required information • company unique information can be added using “user defined” database fields • track the manufacturer and lot # for the API or any other ingredients • enter study environment information using dictionary options or type in required information • standard or user defined interval options, both auto-calculated www. microcontrolsolutions. com “Click” for next slide

Initiate a Study Inventory and labels • set inventory by selecting default option or manually enter • make controlled label requests per interval • max equal to requested inventory • all labels numbered x of y by interval • label field content is user defined • bar code enabled • select the label size • define up to 4 default label formats • label color option available • use the label manager to generate all requested labels www. microcontrolsolutions. com “Click” for next slide

Initiate a Study Document Attachment • attach external documents to the study • study protocol • methods • OOS or OOT documentation • investigation reports • chromatography reports • PDF, Word®, or Excel® documents among others www. microcontrolsolutions. com “Click” for next slide

Schedule Samples • schedule samples • “quick month” option • entered time frame • schedule options • print/preview • print forms • filter by criteria • add to laboratory pending list • pending list options • print/preview • filter by criteria • un-pulled samples • testing cycle • products • advanced query www. microcontrolsolutions. com “Click” for next slide

Bar Code Inventory Functions • update inventory • scanner can be detached and taken to the chamber • scan sample labels or entry on “inventory bar code” report • open inventory options • options for bar code or manual reduction • update by date • take “extra” • restore inventory • bar code step 1 • date of the pull • pulled by • bar code step 2 • reattach the scanner and all scanned samples will be downloaded and automatically updated • or you can scan each bar code individually while attached to the computer www. microcontrolsolutions. com “Click” for next slide

Bar Code Testing Cycle Functions • update testing initiation/completion • scanner can be detached and taken to the laboratory • scan sample labels or reporting forms • open testing cycle options • select initiation or completion • options for bar code or manual entry • test initiation/completion • reattach the scanner and all scanned samples will be downloaded and automatically updated • you can scan each bar code individually while attached to the computer • or manually update www. microcontrolsolutions. com “Click” for next slide

Bar Code Integration • bar codes contain the study ID and test interval • based on the function requested the requisite section of the bar code is activated • use the “Quick Call” function to activate a study from the main menu • scan the bar code on a bottle or reporting form to enter results for a study at the designated test interval listed in the bar code • scan the bar code on a bottle, reporting form, or other report to: • generate a summary report • recall a study to edit • generate charts and evaluations • initiate any function that requests the entry of the study ID • scan the bar code on a summary report to: • recall the study in edit mode • generate charts and evaluations • generate a C of A for a test interval • initiate any function that requests the entry of the study ID www. microcontrolsolutions. com “Click” for next slide

Data Handling and Review • scan the bar code on a bottle or reporting form to enter results • enter results for each required test • out of spec results highlighted in red • out of alert results highlighted in blue • compare to previously approved results • add interval comments • multi-level configurable approval process • view interval summary • data approval locks all editing functions • compare the current results to previously approved results www. microcontrolsolutions. com “Click” for next slide

Reporting Functions • multiple reporting options • summary reports • E-Signatures (up to 3 per report) • define the report content • “data only” for each test • “data/dates/references” for each test • define the report layout • list tests for “individual results” • define print order • add/remove tests from the report • use the bar code to activate any functionality for the study • highlight out of spec data if desired • print: • forms • tables • logs • labels • graphics reports • single study • sample to sample • shelf-life single study • shelf-life multiple studies • arrhenius plot • data export function www. microcontrolsolutions. com “Click” for next slide

Micro Control Solutions Stability System II rev. 6. 5 • Our stability software is a Part 11 compliant package • Capable of monitoring a full scale stability operation • Validation services available • On site training • Visit us at: www. microcontrolsolutions. com • Contact us at: new. Customer. Information@microcontrolsolutions. com www. microcontrolsolutions. com Thank you for viewing our presentation “Click” to close