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Streamlining commissioning and qualification 

A close-up of a pharmaceutical production line where small glass vials are being automated through a filling machine. The machinery is precisely aligned to fill each of the vials, showcasing a sterile and efficient manufacturing process.

Dedicated on-site team

KNEAT digital solution

C&Q management across three key departments

Challenge

Managing complex projects with bold ambitions

Our client, a leading player in the pharmaceutical manufacturing sector, embarked on an ambitious investment plan, requiring comprehensive Commissioning & Qualification (C&Q) management across three key departments: Aseptic Manufacturing, Energy (including HVAC), and Supply. They needed a partner who could provide reliable and flexible solutions, seamlessly integrating with their existing teams and infrastructure to support a significant increase in activities. 

Solution

Flexible and reliable C&Q and project management

Since 2020, our partnership with the client has significantly enhanced their C&Q processes, ensuring projects stay on track and within budget. By deploying a robust strategy grounded in ASTM E2500 standards, we streamlined the qualification process, achieving efficient, paperless documentation management through the KNEAT digital solution.  

Our flexible service centre model allowed us to scale resources as needed, providing a dedicated on-site team that supported critical areas such as clean utilities, HVAC, formulation, fill and finish and quality control. This ensured that every aspect of the process met the highest industry standards. 

Outcome

Increased efficiency and knowledge retention 

By integrating our team with the client’s existing staff, we reduced the need for extensive onboarding. And using a flexible contractual model allowed us to prioritise critical activities, ensuring deadlines were met without sacrificing quality. Plus, our long-term presence on-site ensured knowledge retention, allowing for continuity in C&Q processes and project management.

This not only ensured compliance with regulatory requirements but also supported the client’s sustained growth and strengthened their competitive position in the market. 

Benefits

Timely completion of critical activities

Continuity in C&Q processes

Reduced need for extensive onboarding