Validation & Qualification

With evolving regulations and increased global competition, managing a technical infrastructure based on a sound validation foundation is more important than ever.

Validation and Qualification Services

No in-house validation team?

Protocol Link’s validation professionals will incorporate their in-depth industry knowledge and experience to deliver protocols, studies, analyses, reports, and services that are compliant, cost effective, and distinct to your company’s operations, values, business focus, and culture.

Whether your need involves developing a validation master plan, managing global product transfer activities, or simply validating a new computerized system, we will supplement and assist your existing team in planning and executing these tasks while preparing you for compliance with international regulations.

Our team will also help with your new or modified process challenges. From characterizing a new process to scaling-up an existing one, we can assist in identifying critical process parameters (CPP) and developing Design of Experiment (DOE) protocols to streamline the path leading to validation completion.

Protocol Link is comprised of qualified and knowledgeable leaders who will effectively apply expertise and proficiency to your business success.

Our Validation & Qualification services include...

Aseptic Process Simulation (Media Fills)

Cleaning Process Design and Validation

Computer Systems and Controls

Equipment Qualification (DQ/IQ/OQ/PQ)

Facility and Utility Systems Qualification

Process Verification and Validation (PV/PPQ)

Protocols / Field Execution / Final Reports

Requalification / Revalidation

Test Method Validation

Validation Change Controls

Validation Master Planning

Validation Strategy and Assessments