Background

A biotechnology company that develops and manufactures medical products and devices needed to upgrade from a legacy calibration system to meet FDA regulatory requirements. As the company began to grow and expand, it looked to move to a subscription service such as ProCal to obtain additional benefits.

Objectives:

There were five primary objectives that the company wanted to achieve by transitioning to a new solution:

1) Meet and maintain regulatory compliance

2) Migrate existing data to the new solution

3) Have a sufficient number of users within a cost-effective solution

4) Be able to streamline users to all for maintenance reports while it being cost-effective

5) Increased security and accessibility

The company looked for a partner to both successfully implement the chosen calibration solution and to be with the client every step of the way as they looked to transition to the new system and to ensure validation of the food and drug regulations that the client must follow.

Solution

After careful consideration, the company decided that upgrading to ProCal would meet their objectives. The customer also utilized the web-based reporting tool, eView, to ensure that all relevant stakeholders had a user-friendly interface to access information from the system in real-time. While the software validation was handled by a third-party vendor, the ProCal Customer Success Team was there every step of the way to answer questions as they arose and took a proactive role in offering guidance and best practices.

Result

The company has been working with ProCal for over six years and operates completely within the GMP guidelines. Additionally, the company can now easily configure reports to send to various departments within the organization and has a streamlined process when adding or changing users within the system. The upgrade to ProCal keeps the company FDA compliant, saves them time & money, and has improved the company’s overall operations.