FDA Regulated Code Development & Independent Code Validation Services

We have developed dozens of custom applications for our clients in the pharmaceutical, medical device, and biotech industries.  Our clients include:  Merck & Co., GlaxoSmithKline, Bristol-Myers Squibb, Centocor, Ortho-McNeil, Wyeth, Immunicon, ThermoFisher Scientific, Globus Medical, Dentsply, and Ethicon. 

We have extensive experience in the development and validation of custom machine vision, data acquisition, and measurement and control systems that must adhere to strict FDA software engineering and validation requirements. 

We employ a custom software lifecycle model for our development of validated software and we have documented software development procedures which are utilized for such projects.  Our practices and procedures have generated successful audits with clients such as Merck & Co.

In addition to delivering custom software for FDA regulated applications, we can provide independent testing and system validation services for LabVIEW code developed by others.

21 CFR Part 11 compliant applications

We are experts when it comes to developing 21 CFR Part 11 compliant applications and have even developed a toolkit to assist LabVIEW developers with the development 21 CFR Part 11 compliant applications for Electronic Records and Electronic Signature validation.

For more information about the FDA regulated code development and the validation services we can provide, please give us a call and ask for Michael D. Coleman, Ph.D.