Hood-Burbank Associates, Inc. specializes in software validation support services for the pharmaceutical sector. We have been involved in validation activities since the mid 1980's.

We are a group of professional software engineers with extensive experience in pharmaceuticals and a knowledge of regulations and guidelines relevant to the industry. Our consultants have comprehensive backgrounds in computer systems development, with the majority of that being in the pharmaceutical industry in regulated environments.

Our clients include many major Pharmaceutical companies and related support companies located across the U.S. and in Europe. We typically work with Clinical Research, Pre-clinical Research, Information Services, Information Technology, Quality Assurance, and various Laboratory departments.

Validation:

"Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." (FDA- Glossary of Computerized System and Software Development Terminology)

"The process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements." (IEEE - Std. 610.12-1990 Standard Glossary of Software Engineering Terminology)

Software Validation:

"Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development life cycle." (NBS)