Change Control Management

Crave InfoTechChange Control Management

Change Control Management

Situation

  • Life Science industry regulations require detailed process for every change in protocol. Each variation requires documentation and tracked until the final resolution. This process is often paper based and takes anywhere from 30-120 days.

Challenges

  • Complicated list of steps and approvals to achieve compliance.​
  • Typically this is a paper based or semi-automated process which requires extensive manual intervention and the follow up depends upon the knowledge of the specific user involved. ​
  • Excessive paperwork between reports, documentation, and approvals.​
  • Over 150 change control categories and lack of approver structure for each category of change​
  • Over 19000 changes managed by 4500 employees per year

Digital transformation of Change Control Management

Existing paper-based equipment Calibration Process is more error-prone and time-consuming due to errors in locating the right equipment’s due for calibration, no major to ensure the calibration process as per SOP, manual data entry at multiple locations with a lack of on the spot validations resulting impact to product quality and process non-compliance.

Crave InfoTech’s Calibration mobile application will make the end to end calibration process paperless.

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Digital transformation of Change Control Management

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Solution Innovation

  • Fiori based UI, fully integrates with SAP Cloud Platform, SAP PM, QM, and HCM​
  • Change request resolution can be achieved in 3-12 days.​
  • Change request is created directly on mobile application.​
  • Novel application functionalities include Change Request, Task Assignment, and Questionnaires. ​
  • Questionnaire guides the user through every step of the process by providing them with a preconfigured list of objects, questions, and documents for each type of change.  ​
  • User can define action plan and assign tasks to other team members.​
  • Manager dashboard for approver to track end-to-end status of all change requests, quickly approve steps, view reports, and check current status.​
  • Time stamps document each step of the process.​
  • Assists achievement of complete compliance with applicable regulations. ​

Value Drivers

  • Revolutionize your process with completion in 3-12 days, as much as 90% shorter than the usual time frame. ​
  • Eliminate 90% of paper used in recording data.​
  • A disruptive app, pre-packaged to expedite the implementation time, ROI realization, and reduction in TCO up to 80%.​
  • Completely scalable technology that grows with the business.
  • In app barcode scanner and signature capture capabilities.​
  • Fully configurable, user-friendly UI from the back-end.​
  • Multi-lingual capabilities.​
  • Fully responsive with iOS, Android, Tablet, etc. without the need for any additional time consuming add-ons.

Solution Environment

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