100% Employee Owned, Founded 1954

FDA Validation Services

Whether you are upgrading an existing control system or installing a new one, Cross Company can offer an FDA validation package at the completion of the project to keep you compliant with the FDA. This will verify how we programmed the system and that we programmed the system to your standards.

Cross has significant experience in creating these validation packages in FDA environments. All of our engineers have extensive cGMP experience from an operational and software perspective, so they know the correct and current do’s and don’ts for these highly regulated environments.

Cross follows a GAMP 5 (sometimes called GAMP V) methodology and our validation packages typically contain:

  • Functional design specification (FDS)
  • Detailed design specification (DDS)
  • Installation qualification and operational qualification (IQ/OQ)
  • Software manuals
  • Traceability matrix

Other elements can be added to the validation package as necessary according to your quality or operational requirements.

FDA Validation Services 1
Sample IQ/OQ Document

Cross Company’s validation packages are based on easy-to-read templates. This ensures our documents are not only written in plain English but also that they are much faster and efficient to produce. As we continue to work on your system, we can continue to update the validation package as necessary.

Working in a cGMP environment and considering a new or upgraded system? Contact the experts at Cross’s Process Solutions Group to discuss your requirements.

See how our process solutions team can help improve quality, increase efficiency, and reduce risk

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In the meantime, enjoy these fun facts…

Did you know... the precision measurement group at Cross was founded in 1939 by our current CEO's grandfather, Jim King. That's a whole lot of calibration!
Did you know... A fingerprint weighs about 50 micrograms. We know, we weighed it! The residue left from a finger can actually make a difference in weight results which is why we wear gloves when we calibrate weights. For reference, a sheet to paper is about 4.5 grams, that’s 4.5 million micrograms.
Did you know… Cross Company is an ESOP (Employee Stock Ownership Plan). Our ESOP started in 1979 and as of 2006, we are a 100% employee owned! Learn more about our ESOP and how that benefits both team members and our customers.
Did you know… Cross Company has grown significantly since our start in 1954. Over the years we've acquired 26 companies! Today, our five groups have expertise in everything from industrial automation to precision measurement, and industry knowledge going all the way back to 1939.