The Comos AQM additional module was developed on the basis of the very stringent legal stipulations concerning the provision of data and documentation. In recent years institutions such as the FDA (Food and Drug Administration) in the USA has further tightened up its requirements concerning the validation and operation of plants and units. This concerns in particular the need to be able to subsequently trace the state of the unit or plant during the operational phase. Changes to batch processes can thus have a direct effect on the parameterization of the process control and automation systems, but also on the documentation of the plant or unit.

Working in collaboration with the pharmaceutical industry, innotec therefore developed a solution that makes it much easier to keep such documentation and saves time when doing so. The package extends the Comos Basic License with the following main functions:

• Audit trail
• eSign
• eStamping
• Anonymous file access (reports, revisions, DVM)

Nowadays the factor of time is one of our most commodities. The number of documents that need to be checked and verified is increasingly constantly. Currently documents of this type are printed out and signed on paper. In the Internet an increasing number of companies offer their customers the option of online processing, but unfortunately conventional methods cannot guarantee offering adequate security for these complex applications.

Thus we have implemented with Comos the ability to sign third-party documents in an electronically secure way (eSign) and the signature burnt into documents that have been put through the revision process (eStamping). Any manipulation made to the contents of the revisions can be detected with the aid of digital signatures and the signatory can be identified clearly and uniquely.

Key Benefits

• In conjunction with the Working Layer Technology in Comos The operator gets a system with which he can plan, validate and operate his plants and units in a controlled way.

• The electronic signature in Comos is just as secure as a handwritten signature on paper and a bank transaction in the Internet.

• Any manipulation made to the contents of e-mails and other documents can be detected with the aid of digital signatures and the sender and the recipient can be identified clearly and uniquely. Digital signatures are thus the virtual replacement for signatures in actual everyday life.

• The functionality of the audit trails puts into the hand of the plant operator the option for true control over critical parameters, such as the logging of calibration work.