Adaption of Paperless Validation

We ensure a smooth transition from the existing system to adopt the paperless validation system. We also ensure a well planned defined approach for the successful implementation of the project. Please find our phase-wise project execution model to help pharma companies to go digital.

Discovery Phase

Discovery Phase

  • Understanding existing paper based manual system
  • Analysis on current organization Validation Master Plan (VMR)
  • Inventory of exiting GxP systems. (Both software, hardware and Instruments)
  • Understanding on existing Audit reports by various regulatory bodies
  • Review of existing SOPs
  • Understanding IT organization policies

Planning Phase

  • dentify the project which needs to be implemented using paperless validation tool
  • Identification of key users for product training.
  • Enabling a pilot project to showcase the product features to the identified users
  • URS preparation, project planning and task allocation.
  • Agile way of project execution
project planning phase

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Implementation Phase

  • We offer multiple deployment & costing models that suit our customer’s internal and external needs. GoValidation software can be deployed at the customer’s data center (on-premise) as well as public clouds such as AWS and Google Cloud Platform.
  • System comes up with predefined templates and allow users to customize the existing templates. System also allows user to upload user defined templates
  • Proving single point of contact for immediate query and support
  • CSV consultant will ensure the smooth project execution.
  • Ensure the project is on track by conducting scrum stand up meeting
  • In case of any support, the consultant provides online / email / screen sharing support.
  • User acceptance and end user sign off

Support & Audit Phase

  • Defining clear SLA during the contract phase which will help for the customer to get a single point of contact during support.
  • In build Knowledge base with videos of training material for immediate assistance
  • On demand CSV consultant for ongoing project support if required
  • On demand support during regulatory audits to showcase the paper less validation.
post delivery support

GoValidation offers following features that enable the organization to implement efficient, paperless validation solution:-

  • URS, Risk assessment, Deviation Management, auto generation traceability matrix
  • Screenshot, video recording of test case execution.
  • Complete transparency during validation cycle 
  • Provides single sign on capabilities (Can be integrated with Office 365 and exchange server)
  • Provides inbuilt DMS to store and retrieve digital documents
  • Can be interfaced with existing document management systems like Sharepoint, File net etc
  • Inbuilt Project planning , task allocation and follow-up system.
  • Dynamic form builder and custom workflow
  • Electronic signature and detailed audit trial and much more

For more details , please contact us