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Validation Systems Inc. (VSI) is a full service validation contractor and laboratory service provider. We have been servicing the pharmaceutical, biotechnology, and medical device industries since 1990. VSI is owned and operated by validation professionals. Our management team consists of individuals with diverse backgrounds.

We offer all levels of validation support from start to finish large scale projects to small individual projects. Our team consists of individuals with a broad range of experience and expertise that allows us to work on a wide variety of projects.

VSI is registered with the U.S. Food and Drug Administration (FDA).

Validation Systems, Inc. Laboratory Services is an independent testing laboratory offering a range of microbiological and chemistry services to the pharmaceutical, biotechnology, and medical device industries.

VSI Laboratory Services include the following:

  • Routine Environmental Monitoring

  • Compressed Gas Sampling and Analysis

  • Water Sampling and Analysis

  • Microbiological Analysis

  • Microbiological Assay Development and Method Validation


The VSI Laboratory is registered with the FDA.

All testing is performed in accordance with applicable Good Laboratory Practices (GLPs). A comprehensive Quality Manual, Standard Operating Procedures (SOPs) and Training Program regulate and monitor all aspects of our laboratory practices. We encourage our clients and potential clients to visit and audit our facility, supporting documentation and quality programs to ensure complete confidence and trust in our qualifications.

Quality customer service, flexibility, on-site service, and fast turnaround times are integral to our program. All final reports and supporting documents are held in strict confidence.

VSI can work with your Quality department to develop a customized Quality System that meets your specific need while also addressing all regulatory compliance requirements. We realize that a Quality System must be thorough and Our focus is on creating Quality Systems that are thorough, but also easy to follow.

Our Quality System Development services include:

  • Quality Manual and Quality System Procedures Writing

  • Gap Analysis and Quality Audits

VSI is comprised of highly motivated validation professionals with a strong work ethic and a wide range of capabilities and experience. Our field intensive nature ensures that your company will receive the necessary level of technical support required to meet your validation needs. No matter how small or large the project, VSI has the expertise to startup, adjust and when necessary troubleshoot equipment and utility systems.

We have a wide array of calibrated test equipment available for use in our projects. This allows us a great deal of flexibility in the type of testing we are able to support and scheduling of testing ensures all VSI personnel are skilled in the use of our test equipment.

The VSI team of validation professionals have the strong technical writing skills necessary to ensure that the documents we produce are of the highest quality. We realize that well written documents are both technically correct and accurately written.


Our validation and technical services groups provide the following contract services:

  • Project Management and Project Plans

  • Design Review

  • Validation Master Plans/Risk-based Strategies

  • Construction Qualification

  • Facility Utility System and

  • Equipment Validations

  • Standard Operating Procedures (SOPs) and Preventative

  • Maintenance Procedures (PM) Writing

  • Computer-Related System Validation

  • QC Analytical Equipment Validation

  • Process and Cleaning Validation

  • Risk Assessment and Mitigation Strategies

  • User Requirements/Functional Specifications

  • Traceability Matrix

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