Plant iT provides an integrated system platform for automation solutions in the process industry. The process control system covers the complete range of automation and information technology – from the field level to the corporate management level.
The systems have become increasingly popular in the pharmaceutical industry since 1999 and have been and will continue to be adapted to the growing number of requirements demanded by European and US authorities.
Regulation 21 CFR Part 11 of the US Food and Drug Administration (FDA) became effective on 20 August 1997. The regulation describes the FDA requirements on the use of electronic records and signatures instead of traditional paper records. Generally speaking, these electronic records must provide the same level of performance as would be the case with paper records. Furthermore, there is the possibility of using a combination of electronic and paper records.
What is 21 CFR Part 11?
The "21 Code of Federal Regulations (CFR), Part 11" details the legal provisions of the US Food and Drug Administration (FDA) on the use of electronic records and electronic signatures.
The regulation, which became effective on 20 August 1997, was developed over a period of six years in collaboration with various authorities and the pharmaceutical industry. Part 11 of this regulation specifies the legal requirements for the acceptance of electronic records and signatures as equivalent to paper records and handwritten signatures executed on paper. Part 11 assumes the risk of manipulation and non-traceable changes to electronic records and signatures is greater than for paper records and signatures, meaning additional measures are necessary.
Records required by the FDA
Plant operators subject to FDA regulations must manage various records for the products which they manufacture. 21 CFR Part 211, Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals, Subpart J, defines them. The explicitly required records and reports contain the following:
- Logs of device application and cleaning
- Records of raw materials, packaging and labelling
- Central production and control records
- Batch production and control records
- Laboratory reports
- Sales reports
For some of these records, e.g. the batch records, large parts of the required information are recorded or created by a computer system. The requirements placed on the type of information are not affected by Part 11.
In its Compliance Policy Guide 7153.17, the FDA specified regulations for the implementation of 21 CFR Part 11 in which FDA inspectors are granted greater freedom with regard to regulatory measures. The FDA does not issue certificates for products, e.g. Plant iT, and no other independent authority is permitted to do this. The plant operator must always satisfy the specifications of 21 CFR Part 11 according to the specific application. Whether the prerequisites are satisfied is decided for each specific case.