Quality Systems

Protocol Link’s Quality Team will provide valuable and informed insight for developing and implementing your company’s comprehensive quality plan. We will also advise and assist you in launching and sustaining your company’s quality management systems and continuous improvement initiatives.

Quality Systems Services

Want a Quality approach with vast industry expertise?

Protocol Link partners with you to strengthen your quality management system.  We review and assess batch records, change controls, deviations, and associated cGMP records. We also work with supply chain personnel to ensure timely batch release and attainment of customer requirements. We are experienced in managing product complaints, conducting thorough investigations, and identifying and implementing corrective and preventive actions.

Additionally, our experienced analytical team is committed to working closely and comprehensively with your quality control unit and laboratory staff to facilitate successful analyses, assess test methods and data integrity, and investigate exception results.

At Protocol Link, our expertise stems from the depth of our project resources who have combined industry experience in compliance, quality assurance, and validation services. From developing standard operating procedures to evaluating a potential business acquisition, Protocol Link is prepared to meet today’s global regulatory compliance requirements.

Our Quality Systems services include...

Annual Product Reviews

Investigations and CAPA Management

Lab Investigations (OOS/OOT)

Product Complaint Management

QA / QC Management

Quality by Design (QbD) Q8-Q14

Quality Management Systems (QMS)

Quality Master Plans

Sampling, Inspection, and Testing

Stability Program Management

Training Programs

Vendor-Supplier Audits