We can assist in developing and documenting your projects User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Trace Matrices to meet FDA requirements.

We can assist in documenting your qualifications while ensuring the latest in Risk Based compliance, saving you time and money.

Our engineers have experience with a wide variety of equipment types. We can assist in troubleshooting equipment issues and smooth the transition into newer technologies.

Setting the correct ranges and parameters is critical in ensuring your equipment performs as needed with minimum deviations.

Developing an efficient action plan with realistic timelines is the architecture on which adequate validation protocols are built.

An independent perspective, with unbiased insight can help you look at your operation in a new way. Our wide client experience and ASQ certified quality auditors can bring the best practices to you quickly without timely trial and error.

Transferring a process is a great opportunity to increase efficiencies and upgrade your equipment.

A majority of FDA 483 observations include cleaning validation non-compliance. Cleaning validation is an area of intense scrutiny. Our experienced engineers can help you avoid this common pitfall and eliminate the headaches.

ISO 14644 requires annual reviews of facility performance. We have excellent procedures for developing a clear, concise report for warehouse qualifications.

Our experienced professional engineers can make system improvements work for you.

Our statistical analysis methods can identify the causes of deviations in your system.

Rolling out a state of the art software system can be a challenge. We have the patience and training experience to make new systems work for you.

Our analysts have worked with a variety of quality related software systems and can help ensure that your system testing is appropriate.

Adequate development and execution of test scripts is essential during software validation. Our experienced staff can make this tedious process go smoother for you.

“Failure to follow approved procedures” is one of the most common 483 observations. Put our experience to work in making your procedures realistic, useful and cGMP compliant.