Fully Integrated, Seamless Validation Services

AAIPharma's Validation Services enjoys an unblemished track record of providing timely, cost effective solutions to our customer's compliance challenges. Whether it is the challenge of setting up a validation or qualification program or an emergency response to a critical compliance situation, our Validation Services Team will respond to your needs with proven expertise, confidence and resolve. With AAIPharma you will receive the highest quality service conducted with the strictest confidentiality.

We Offer:

• Customized Validation Master Plan Development
• Project Management
• Design Qualification
• Factory and Site Acceptance Testing (FAT, SAT)
• Start-Up and Commissioning
• Installation, Operational, and Performance Qualification
• Protocol Execution
• Final Report Development
• Standard Operating Procedures (SOP) Development and Implementation
• Laboratory Training and Re-certification
• Vendor Audits
• Laboratory Support for Validation Samples

AAIPharma's Validation Services Team has over twenty years of operational experience and expertise in a wide variety of areas. We are proud of our long history of successful audits of our facilities and systems by both clients and regulatory agencies.

Qualification templates that satisfy all USP/EP requirements for all critical utilities allow us to design a qualification for any system large or small. A large inventory of qualified instruments provides on-site testing in addition to in-house laboratory testing. We also provide shipping studies and annual evaluation reporting as needed

The benefits in choosing our services are:

• Single point of contact
• Cost effective
• Alignment of resources
• Enhanced trouble shooting capabilities
• Expedited services
• Consolidated reporting
• Single point auditing

Client Testimonials:

"The services provided by AAIPharma were very professional and timely; the need for immediate quality assistance was a vital requirement for my project. All of my requirements were met and the contractors assigned to the project were very knowledgeable of current validation processes and practices. The contractor's ability to complete the projects within the timeline provided was very instrumental to my success as the project manager and the overall success of the project. I would recommend AAI Pharma's services to other colleagues in the industry and will utilize their services for up coming projects in my organization."

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