Analytical Instrument Qualification Support

The Client

A leading pharmaceutical testing laboratory.

The Challenge

The client needed to qualify several new analytical instruments, but lacked the staff to complete such a large undertaking and the budget to hire additional personnel. They reached out to Actalent for validation engineers to support the project, trusting us to provide the right experts to execute it successfully. Specifically, the client sought validation engineers with experience in writing and executing URS and IQ/OQ/PQ documents, as well as expertise in CVS for validating the instruments' operating system.

Without additional support, the client would have struggled to manage the writing and execution of protocols while maintaining their regular testing schedule. They would have been unable to get the documents authored, approved, and executed in a timely manner, which would have delayed their operations. As a result, they risked failing to test products on time, meet client demands, and maintain their reputation as a leading testing laboratory.

The Actalent Solution

Actalent’s goal was to build a strong team of initiative-takers with the exact qualifications and abilities critical to the project's success. Actalent aimed to deploy engineers with excellent communication skills who could understand the specific qualification and CSV requirements of each instrument. These individuals would also have the ability to author comprehensive URS documents and qualification protocols, as well as execute them with an understanding of technical operations and testing requirements in accordance with GMPs, 21 CFR Part 11, GAMP 5, and the client’s specifications.

The project team assembled by Actalent included a validation engineer and a project manager, with a combined thirty-five years of experience working with and qualifying analytical instruments. The team had expertise in analytical test method validation, technical writing, quality control, quality assurance, CSV, and the qualification and validation of analytical instruments.

Both team members had proven abilities to tackle the qualification and validation protocol work required.

The Results

Actalent’s ability to quickly deploy an experienced team of engineers, equipped with the skills specified by the client – such as technical writing, analytical instrument qualification, and computer system validation – allowed the client to meet their qualification deadline. Actalent’s success in completing the project on time and under budget enabled the client to maintain their regular testing schedule and deliver results to their clients as expected. By meeting this deadline, the client avoided tarnishing their reputation, continuing to meet customer demands and remain on schedule. Their standing as a responsible and quality testing laboratory remained intact.

Actalent managed the project remotely, allowing the client to proceed with their daily testing schedules. Remote work not only ensured that the client stayed on track, but also significantly reduced their cost of compliance. The client was able to meet with Actalent’s team on a weekly basis, staying updated on the project and providing insights without disrupting schedules or incurring additional travel expenses.

The client was pleased with Actalent’s performance and expressed satisfaction with using Actalent's services for future projects.

Actalent was the right partner because we provided the right talent and team to support the work.