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Instrument Calibration Management System
Werardt Systemss Pvt Ltd offers an Instrument Calibration Management System (ICM), a web-based solution designed to manage and maintain organized calibration records for various instruments. The system ensures data integrity, compliance with 21 CFR Part 11, and provides control over user access and calibration procedures. Key features include audit trails, email notifications, and customizable user rights, streamlining the documentation and scheduling processes associated with instrument calibration.
Instrument Calibration Management System
- 1. A presentation byWerardt Systemss P Ltd I C M The Instrument Calibration Management System 1ICM Instrument Calibration Management System
- 2. Werardt offers varioussystems like, ERP, Plant Maintenance, Sales & Distribution, etc. to the Industry apart from specialized systems for the past 15 years. About Werardt & ICM Now, based on its Nucleus Application Development Platform it offers ICM, a comprehensive, easy-to-use solution with the ability to maintain long term, organized, and readily accessible calibration records of all types of Instruments. 2ICM Instrument Calibration Management System
- 3. The ICM WebClient allows you to implement a zero footprint, web-based application that can be accessed by using Internet Explorer® or any similar Browser, thus eliminating the need to install software on the client side. While the ICM Web Client manages the user interface, the application logic and data management are handled by the ICM Server. This simplifies deployment of ICM and reduces the time and effort required to validate the solution in a regulated environment. A Web based Solution 3ICM Instrument Calibration Management System
- 4. ICM Block Diagram InstrumentInstrument Type Parameter Range One or More Master Certificates No. of Points SOP Calibration Procedure Calibratio n Certificate Calibratio n Schedule Calibration History Calibration Agency Department Unit Section Frequency 4ICM Instrument Calibration Management System
- 5. Key Validations performed Thekey to a successful system will always be the control over various validations that govern the sanctity of the Calibration certification process. These mainly being, SOP date Validation Master Certificate Validation Schedule date Validation Validate correctness of entries on set acceptance criteria, and Calibration Agency Contract Validation Active Directory Integration for Domain User Validation 5ICM Instrument Calibration Management System
- 6. ICM provides asound control over access to its features related to Insert, Edit, Delete and Print, for any user. This is based on the security rights that can be applied to every set of users. Some of the features are, Unique username & password per user with Active Directory Integration System administrator can decide access rights to users Time stamp is recorded against every change in the system Maintains an Audit trail A log of every operation in the system is maintained Email Notifications The system is 21CFR Part 11 compliant User Access Control & System Security 6ICM Instrument Calibration Management System
- 7. ICM can beused to authenticate calibration procedures through the creation of specific calibration methods. Using ICM for calibration procedures: Ensures the integrity of the data that is entered Ensures that the calibration procedure is followed as defined Provides thorough documentation of instrument calibrations Reduces the cost of documenting calibration results As a calibration management solution, ICM simplifies the documentation, data recording and scheduling activities associated with instrument calibration. Authenticity & Benefits 7ICM Instrument Calibration Management System
- 8. ICM - SomeSample Screens 8ICM Instrument Calibration Management System
- 9. Master Data requiredto Start Information that will help collect all data that is relevant to the Instruments is the first step towards initiating the system in your organization. This is the Information which will help define the various validation and acceptance criteria mentioned earlier 9ICM Instrument Calibration Management System
- 10. The Department &Section Master 10ICM Instrument Calibration Management System
- 11. Instrument Type Master 11ICMInstrument Calibration Management System
- 12. Instrument Listing 12ICM InstrumentCalibration Management System
- 13. Instrument Details … continuedin next slide 13ICM Instrument Calibration Management System
- 14. Instrument Details … continuedfrom previous slide 14ICM Instrument Calibration Management System
- 15. Parameter Master 15ICM InstrumentCalibration Management System
- 16. Instrument Type -Parameter – Range 16ICM Instrument Calibration Management System
- 17. Master Certificates 17ICM InstrumentCalibration Management System
- 18. Pending Schedules fora Period 18ICM Instrument Calibration Management System
- 19. Calibration Entry … continuedin next slide Note: Once the calibration details are entered the certificate can be printed using the above option, based on the various validations acceptance criteria and the access rights that the user has 19ICM Instrument Calibration Management System
- 20. … continued fromprevious slide Note: Here you can take the “Before” and “After” readings based on the Parameter, Range and no. of points defined for that Instrument Type Calibration Entry 20ICM Instrument Calibration Management System
- 21. Sample Reports &Outputs The System provides various report outputs that can be used for Operations as well as analysis. Here are some of the outputs that ICM provides … 21ICM Instrument Calibration Management System
- 22. ICM - SomeSample Reports 22ICM Instrument Calibration Management System
- 23. Master Calibration Planner 23ICMInstrument Calibration Management System
- 24. The Raw DataForm 24ICM Instrument Calibration Management System
- 25. Instrument List 25ICM InstrumentCalibration Management System
- 26. A Sample CalibrationCertificate 26ICM Instrument Calibration Management System
- 27. Contact Information Werardt SystemssPvt Ltd Pune, India Phone : 91-20-25285256, 25285257 Website : http://www.werardt.com email: business@werardt.com 27ICM Instrument Calibration Management System