Pharmaceutical Manufacturing
Case Study

Analytical Calibration and Validation Support

As a producer of household name over-the-counter drug products, our pharmaceutical manufacturing client aims to make a difference in peoples’ lives around the world. Joulé shares in this mission by providing analytical, calibration, and validation services to ensure the safety and accuracy of laboratory instrumentation and process equipment. We have provided a flexible approach to resource management by combining full-time staff with specialized talent on demand, introducing best practices, and minimizing equipment downtime.

Client Scenario

Unsatisfied with their previous vendor’s scope of available services and quality issues, our client sought a partner qualified to handle a diverse range of analytical, calibration, and validation needs. The Analytical Services Manager for the Research & Development department formulated detailed technical requirements for an RFP, and Joulé was invited to participate based on a strong referral from the firm’s parent company, also a client.

Provisioning and maintaining analytical equipment requires significant ongoing capital requirements, so asset lifecycle management was a huge concern. Additionally, the client needed access to immediate qualified resources to handle unforeseen issues and special projects such as validations and commissioning.

Joulé worked with procurement as well as the client’s quality and compliance departments to ensure our response met both budgetary and quality constraints. Based on our deep talent pool and proven processes, we were selected as the primary equipment services vendor.

Joulé Solution

For the past three years, Joulé has provided multiple departments with analytical, calibration, and validation services for laboratory instrumentation and process equipment. Three full-time salaried Joulé employees work onsite, augmented with additional specialized resources as needs arise. Our services cover a wide range of equipment types from multiple manufacturers.

The client requires individual skill sets across a broad range of capabilities, from analytical instrument engineers and calibration technicians to validation engineers. Joulé has also supported the client with technical writing expertise to document best practices.

As Joulé’s reputation for responsive service has deepened, we have taken on additional responsibilities. We provide comprehensive validation services to ensure that user needs and intended uses can be fulfilled on a consistent basis. Additionally, we play an active role in the qualification and commissioning of new equipment.

Client Benefits

Joulé has an established high level of quality and compliance with pharmaceutical customers in part due to our ISO-9001 and ISO/IEC 17025:2017 accreditations. Our highly experienced staff receives continual training and skill set advancement to keep pace with expanding equipment service requirements. Because Joulé has the capacity to quickly ramp up recruiting efforts to meet customer demands, the client has increased its agility and productivity.

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Joulé delivers proven resources across a broad range of capabilities, from analytical instrument engineers and calibration technicians to validation engineers.