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Use Case

Introduce a CFR21 Part 11 compliant digital model to manage GPM Process

This Pharma customer decided to use CheckLyst to document Equipment and Production Line Cleaning to reduce significantly the time spent for reviewing paper forms and the number of quality issues caused by errors in filling the paper forms.
After this first implemetation the use of CheckLyst has been extended to digitize other GMP processes relying on the fact that the system performs all critical checks automatically and the validation of CheckLyst ensures adherence to GMP Pharma regulations. The system has been scaled up to other worldwide sites.
For this customer CheckLyst has completed the mosaic of the digitalization process.

Processes managed:

  • Equipment and production line cleaning 
  • Line cleaning status check
  • Recipe management
  • Label reconciliation
  • Overdue training impact assessment
  • Master batch record management
  • Batch record review management

Benefits: Digitizing Equipment recipe and format process

  • Uman error decrease - Workflow controls
  • Reductions of critical exceptions and unexpected results
  • Paper-based processes reduction - Compliance improvement
  • Automatic checks that reduce time for review

Optimization of Equipment recipe and format process

This customer decided to use CheckLyst to document the change management of production lines format and recipe. The need of the customer is to control the workflow for the creation of a new line format to ensure that all the impacts and risks are evaluated and shared among the stakeholders before the implementation of the change in production and to guarantee compliance and respect of the times.
After this first implemetation the use of CheckLyst has been extended to all production lines.
For this customer CheckLyst has triggered the digitalization of cross-departments processes.

Processes managed:

  • Digitization of change recipe\format management process
  • Digitization of qualification activities for the recipe\format process
  • Extend new approach to other packaging lines
  • Process standardization

Benefits: Digitizing Equipment recipe and format process:

  • Production schedule acceleration
  • Increased line availability for production purpose
  • Recipes process management standardization (compliance, personnel, time)
  • Reduce lead time for recipe/format management for 2 packaging lines
  • Compliance on assembling packaging lines
  • Paper-based processes reduction

Digitization of Batch Record Management

This customer decided to use CheckLyst to document the Batch Record process. All steps of Batch Record have been digitize improving the robustness of the process and reducing risks of error in the execution and documentation of the activities. The CheckLyst mobile app has also allowed to extend the use of the system in production areas where the use of PCs is not possible.  The introduction of CheckLyst for this customer has represented an opportunity to promote the digital trasformation not only in one site but also to other sites of the Company. Thanks to the flexibility of the system and of its cloud architecture the solution can be fastly and easily scaled up to other sites.

Processes managed:

  • Replacement of paper batch record process with a digital model
  • Optimization of bacth record process
  • Compliance improvement
  • Data traciability
  • Generation of electronic batch release certificate

Benefits: Improve batch record process

  • Human errors decrease – workflow controls
  • Auditable data and timing control
  • Review by execption
  • Manufacturing overall process control
  • Paper-based processes reduction



The digital solution