Slingshot Announces GxP Validation Package
Slingshot has extended its pharmaceutical software offering to include software and services allowing pharmaceutical manufacturers and laboratories to meet the ongoing needs for software validation. The GxP Validation Package includes documentation, test scripts and an environment for efficiently completing required GxP validation processes.
Operational Qualification Scripts
Each menu item for each user role in the eStock-Pharma application is associated with one or more test scripts. Each script has set up documentation and detailed test steps. In total, over 100 test scripts provide click by click proof that all application functions comply with the Functions Specification document and your SOPs.
Installation Qualification Templates
Installation qualification documentation provides a step by step process for provisioning IT resources, and deploying both software and data. Final verification steps prove the installation was completed successfully. Installation Qualification templates are available for both “On Premise” and “Hosted” deployments.
Functional Specification Document
The Functional Specification document provides screen shots and a narrative description for each user role (e.g. Quality Assurance, Warehouse, Manufacturing, Supply Chain etc.) and menu item. A Traceability Matrix document ties each item to Operation Qualification scripts that validate the functionality provided by the menu item.
Quality Testing Environment for OQ Execution
The Validation Package includes a testing environment hosted by Slingshot allowing you to efficiently validate a software release. Each release is associated with a library of 100 or more test scripts. A typical test scripts has dozens of test steps. Each step is completed and marked “Pass” or “Fail” by the tester. If a step fails the status of the Script automatically changes to “Awaiting Repair”. A repair ticket is generated tracked through resolution. When an issue is resolved the status of the script automatically changes to “Awaiting Retest”. Certain test steps will require attachments as “proofs”.
Release Reporting to Meet FDA Audit Requirements
The Release Master report shows all test scripts, test steps and results. It provides proof that all functions were tested for all roles and all tests were passed.
The GxP Validation package includes services to adjusted scripts and documentation to comply with your SOPs and customer functions. For more information contact Slingshot sales representative at This email address is being protected from spambots. You need JavaScript enabled to view it..