"Excellence in Service"

We offer an effective blend of computer related systems (CRS) validation, quality software development auditing, cGMP compliance in automated systems, and 21 CFR Part 11 services, achieving excellence unparalleled in the industry. Our rich experience in computer systems in GMP applications dates back over 25 years. Our people are the simple key to the excellence, dedication, experience and skill that will make your computer validation project a real success.

Key Areas of Expertise

• Process Controls
• Automation
• Data Collection, Archive, Retrieval

Our Methods

We apply the generally accepted PMA (the former Pharmaceutical Manufacturer's Association) model for computer validation or GAMP 5, as you prefer. These models are life cycle approaches endorsed by industry, vendors, and the Food and Drug Administration (FDA). They can be confusing, hard to understand and even harder to apply to your specific project. Let us help your staff break through the confusing world of validation steps and terminology.

Process Controls

From isolated equipment or systems to total plant control, we will plan, develop, and execute the complete program. When we are done, we leave systems that are robust, well designed, and work reliably. We can assist in the entire GAMP 5 process, beginning at the conceptual stage (often the most critical, and the most neglected). We are experts in integrating process control qualification with the qualification of the controlled systems.

Automation

We will assist you in the development of highly integrated, GMP based automation strategies. Exactly what should you automate? How do you balance the upfront capital cost with daily operating efficiencies? How does the new risk-based GMP model impact my automation plans? We can help you think, plan and execute in this critical area.

Data Collection, Archive, Retrieval

Data is the most valuable product of a computerized process control system. Done well, a robust data system will archive accurately, reliably, or tell you immediately if something is wrong. That is the Gavin Pharmaceutical Services way to great data systems.

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