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Quality Operations (Processes and Systems)

Where quality operations may be a cost center for some, truly evolved life sciences organizations know that a proactive approach to quality yields far more than a passing grade – it propels your whole business, forward.

THE BUSINESS CHALLENGE

Quality operations – your biggest threat or greatest asset?

Our regulatory landscape seems to produce new quality mandates and guidelines nearly every day, creating significant challenges for any quality professional. How can you ensure the highest levels of product safety and efficacy, while simultaneously moving product as quickly as possible through your supply chain to meet your increasingly crunched production schedule?

Solutions

With Clarkston as your partner, we design and implement quality processes and systems that fit your organizational objectives – today and tomorrow.

Sustainable and effective quality begins with a base of learning and organizational design that nurtures both capability and culture.

  • Organizational Effectiveness
  • Training
  • Change Management
  • Learning Management
  • Testing

Realizing operational efficiencies in your quality management processes improves your ability to both deliver safe and effective products, and handle out-of-specification events.

  • Annual Product Review
  • Batch Release
  • Packaging and Labeling
  • Complaint Management
  • Deviation Management/CAPA

Fully harmonized systems of data and technology are your greatest asset for continuous quality.

  • Systems and Data Integration Roadmap
  • LIMS Implementation and Support
  • eQMS Implementation and Support
  • EDMS Implementation and Support
  • Materials Management

What Our Clients Say

Clarkston Consulting Client Quote

Director, Global Quality Operations

Global Pharmaceutical Company

Clarkston is proactive in bringing continuous improvement ideas to the table. I value the experience they provide in the LIMS space. I haven’t seen this level of experience with other professional service providers we’ve engaged with.

We helped a life sciences manufacturer reduce lab cycle times by 60% and manufacturing cycle times from 120 days to 60 through assessment of their existing quality processes and implementation of new protocols and efficiencies. For more information on how we can help your company, please contact our quality operations expert, Nicole Taylor.

Contact Nicole

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