Life Science

Quality

As specialists in the healthcare industry, we understand that quality issues are essential to ensuring the reliability and safety of our customers’ products. Our quality expertise addresses the specific challenges of this demanding sector, ensuring that standards are met to guarantee patient safety.

Our pragmatic approach minimizes the risks of failures and non-compliance.

We support our customers in managing manufacturing and control processes, ensuring the consistency and quality of each product batch.

 

Quality Assurance (QA):

  • Operational QA: CAPA, deviation, change control, batch record review, investigations
  • Supplier Quality Assurance
  • Monitoring and maintaining compliance
  • Continuous improvement
  • Review and approval of protocols/reports

 

Quality Control (QC):

  • Development / Validation / Transfer of analytical methods
  • Stability monitoring and trending
  • Laboratory equipment qualification

 

Quality management:

  • Quality management system
  • Audit preparation, quality system upgrade
  • DATA Integrity