Plant iT provides a uniform system platform for automation solutions in the process engineering industry. It covers the complete area of the automation and information technology from the field level through to the enterprise resource planning level.Since 1999, the systems have been used increasingly in the pharmaceutical industry so that they have been and will be continually adapted to the growing requirements demanded by the European and US authorities.

The 21 CFR Part 11 regulation of the US authority FDA (Food and Drug Admin-istration) took effect on August 20, 1997. The regulation describes which requirements the FDA places on the use of electronic recordings and signatures rather than those in paper form. These must be equivalent to the traditional recording in paper form. It is also possible to use a combination of electronic recordings and recordings in paper form.

The 21 Code of Federal Regulations (CFR), Part 11 title contains the legal regulations of the FDA (US authority for supervising food and medicinal products) concerning the use of electronic recordings and electronic signatures.

After six years of cooperation between various authorities and the pharmaceutical industry, the final regulation took effect on August 20, 1997. Part 11 specifies the legal prerequisites under which electronic recordings and signatures are accepted as being equivalent to recordings on paper and handwritten signatures.
Part 11 assumes that the danger of manipulation and non-traceable changes to electronic recordings and signatures is greater than for paper form and additional measures must be adopted.

Plant operating companies subject to the FDA regulations must manage various recordings for the manufactured products.
21 CFR Part 211, Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals, Subpart J defines what these are. These explicitly required recordings and reports contain the following:

• Log of the device use and cleaning
• Recordings about raw materials, packaging and labeling
• Central production and controller recordings
• Batch production and controller recordings
• Laboratory reports
• Sales reports
• Complaints

For some of these recordings, such as the batch recordings, large parts of the required information are recorded or created by the computer system.
The requirements placed on the type of information are not changed by Part 11.

In the Compliance Policy Guide 7153.17, FDA has prepared regulations for the implementation of 21 CFR Part 11 in which they allow the own inspectors large freedom with regard to regulatory measures. The FDA does not issue any certificates for products such as Plant iT, neither is any other independent authority permitted to do this.
The plant operating company must always satisfy the specifications of 21 CFR Part 11 for the specific application. Whether the prerequisites are satisfied is decided for each specific case.