We can help you correctly document the user requirements, design specifications and the trace-ability matrix to meet the requirements of the FDA.

The latest in Risk Based compliance can save you time and money.

Our engineers have experience with a wide variety of equipment types. This experience can help you troubleshoot equipment and can smooth the transition to newer technology.

Setting the right ranges and parameters is the best way to ensure your equipment performs as needed with a minimum of deviations.

A realistic timeline and efficient action plan is the architecture on which validation protocols build upon.

A new set of eyes can help you look at things in a new way.  Our wide client experience can bring the best practices to you quickly without all the trial and error.

Moving a process can be a great opportunity to increase efficiencies and upgrade your equipment.

A majority of FDA audits included cleaning validation observations. Cleaning validation is an area of intense scrutiny. An experienced engineer can help avoid the common pitfalls and remove this headache.

ISO 14644 requires annual reviews of facility performance. We have an excellent procedure for developing a clear, concise report of annual performance.

Use an experienced professional engineer to make system improvements work for you.

Our statistical analysis 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 experience to make new systems work for you.

“Failure to follow approved procedures” has to be one of the most overused 483 observations. Put our experience to work in making your procedures realistic and useful, without tying your hands.