I'm interested in finding out which, if any, HMI software is 100% compliant with the United States Food and Drug Administration (FDA) final ruling on Electronic Records and Electronic Signatures referred to as 21 CFR Part 11. I'm aware that some batching software (InBatch from Wonderware for example) meets the criteria, but am not familiar with any HMI's that do. Any help is greatly appreciated.

 

All my GMP training told me there is no such thing as software that "100% compliant" with any FDA ruling.
Whatever you produce must be explicitly validated - in the case of software products like InBatch then that comes from your assessment of the suppliers QA and and the degree to which the product is a standard and in widespread use.
In the case of the application software the validation involves having a high level of QA and demonstrating that you have followed good software engineering principles. The GAMP guidelines are a good basis for proceeding, see http://www.activa.co.uk/gamp/ - unfortunately you have to pay to get the actual guide.

> I'm interested in finding out which, if any, HMI software is 100% compliant with the United States Food and Drug Administration (FDA) final ruling on Electronic Records and Electronic Signatures referred to as 21 CFR Part 11. I'm aware that some batching software (InBatch from Wonderware for example) meets the criteria, but am not familiar with any HMI's that do. Any help is greatly appreciated.

 

The way I am currently interpreting the ruling, compliance with Part 11 will come from the way the HMI application is implemented as opposed
to being inherent in the HMI package itself. I have a large installed base of Wonderware InTouch, and I am planning fairly extensive
modifications (customized security, audit log functions, etc) utilizing scripts and ODBC functionality of the software to bring the systems
into compliance with Part 11. I am also looking into using some of the NT utilities to address security issues.

Probably, most any HMI package that allows such customizations could be made compliant. (This is my opinion at the moment, however I have not yet begun system remediation.)

 

Intellution has already released some functionality that follow the FDA, for HMI SCda product FIX and iFIX, and others are on the way.
for more info see the web site
www.intellution.com

 

You might look into the latest news release from Rockwell Automation it announced HMI software Design to meet 21 CFR part 11 regulations and they list RSView32 and RSView Active Display software packages, maybe thats what your looking for.

 

Look at the website: www.dmius.com

They are the leaders in software which is compliant to 21 CFR Part 11 regulations. They are helping 7 of the top 10 largest pharm/biotech companies in the world.

They also have free seminars in the United States and internationally. Contact them, they might be able to help.