Case Study: PHARMACEUTICAL CLIENT
Problem before ProCal Direct (Cloud)
The client is one of the biggest pharmaceutical companies in the world. This is a Southeast Asian site with over 4,000 assets at the plant including a secondary facility under construction. The client had decided on a calibration management software before considering viewing a demo of ProCalV5.
Issue 1: The client needed a cloud based validated calibration software to maintain all the assets.
Issue 2: The client needed a flexible software to configure to their specific quality and regulatory requirements.
Issue 3: The client needed a software that could work in an online as well as offline mode.
Issue 4: The client needed a software that could be setup to securely allow third party contractors to access and enter calibration readings according the quality processes of the client.
Issue 5: The client needed a software that restricts use of unapproved test instruments and instruments.
Issue 6: The client needed a software that could work with documenting process calibrators.
Issue 7: The client needed a software that could be later integrated into their SAP system.
Issue 8: The client needed a software that could be expanded to cover more facilities, locations and users.
Issue 9: The client needed to implement their own validation protocols for the software before use at the facility.
Issue 10: The client needed customised bar code label and other types of reports.
Solution via ProCal Direct (Cloud):
Solution 1: The client was provided with ProCal Direct (cloud-based version of ProCalV5) a validated calibration software to maintain all the assets.
Solution 2: ProCal Direct is GAMP 5 certified and offered great flexibility to meet the client’s complex requirements without the need to provide additional programming customisation services.
Solution 3: ProCal Direct was able to serve the client’s requirement to work in an online as well as offline mode, as some parts of the facilities were isolated from internet access.
Solution 4: ProCal Direct was easily configured to securely allow third party contractors to access and enter calibration readings according the quality processes of the client. The added benefit was that the client was able to check the internally produced calibration reports against those provided by the third-party vendors.
Solution 5: ProCal Direct was easily able to restricts use of unapproved test instruments and instruments.
Solution 6: ProCal Direct works with documenting process calibrators. E.g. Fluke 754, 74x, 729 etc.
Solution 7: ProCal Direct can be integrated into their SAP system very cost effectively.
Solution 8: ProCal Direct is easily expanded to cover more facilities, locations, and unlimited users.
Solution 9: ProCal Direct validation scripts was provided to the client along with project management services to ensure that validated to the strict quality and compliance requirements of the client. We were also able to share industry best practice ideas with the client to enhance the quality of their operations.
Solution 10: We were able to deliver the customised label and other reports without adding further time and costs for the client.
Summary: ProCal Direct was successfully deployed for the client along with validation services and report customisation services. The client was incredibly pleased with the overall functionality of ProCal Direct and the services rendered by our team. The client was also able to keep under budget and within their timing requirement.