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.
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
dentify the project which needs to be implemented using paperless validation
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
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
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.
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