Micro Control Solutions Annual Product Review rev. 6.5 “Click” for next slide Move to the next slide when the request appears

Interactive Modular Design “Click” for next slide

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 “Click” for next slide

individually assign a user’s application access define manufacturing user access define QC user access define data merging default Admin. Level User Access Settings 21CFR Part 11 “Click” for next slide

Admin. Level Application Settings Multi-level audit logs application event logs application access logs product and specification library edit logs “Click” for next slide

Library and Dictionary Templates parameter templates tests limits precision # of entries laboratory preference alert limits multiple data entry options “Click” for next slide define equipment “types” used during product define the formulation and packaging components to track product templates name description expiration review period batch sizes define manufacturing sites

System Dictionaries “point and click entry” equipment dictionary abbreviation dictionary analyst dictionary “quick select” dictionary as typical examples... “Click” for next slide

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 “Click” for next slide

Track Customer Complaints “point and click entry” “Click” for next slide 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

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 enter corrective action and date to be completed filter the investigations database using multiple criteria options “Click” for next slide

select your product template Data Handling and Review “Click” for next slide 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

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 “Click” for next slide

Reporting Functions multiple reporting options multiple reporting options summary reports summary reports define the report content define the report content certificate of analysis report certificate of analysis report define C of A parameters define C of A parameters reports by parameter reports by parameter “individual results” format “individual results” format cover page cover page define the report layout define the report layout define print order define print order add/remove tests from the report add/remove tests from the report print: print: tables tables logs logs graphics reports graphics reports parameter charts parameter charts spec changes displayed spec changes displayed parameter overlays parameter overlays 2 y-axis display 2 y-axis display control charting control charting hi-lo charts hi-lo charts “Click” for next slide

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: Contact us at: Thank you for viewing our presentation “Click” to close