PROCOS functionality

PROCOS functionality PROCOS also offers a number of tools to provide the production management level with the required information, e.g. to perform the necessary documentation and validation and enables data pull and push to all leading ERP systems.

Engineering Change Log Engineering Tool is able to automatically make an Engineering Change Log (ECL) or Audit Trail registering changes to objects done via Engineering Tool. In addition to the Standard ECL it is possible (during installation) to specify that additional details of the object is saved together with the change log. The details are saved as a text with the same form and contents as displayed in an extract of the object. As the ECL is provided by Engineering Tool changes done by other unauthorized tools to Engineering Tool tables in the database will not be recorded in the ECL. To prevent changes being done without recording according to the ECL level chosen, tables used by Engineering and all other tables owned by MGR can be protected against update, insert, and delete done via programs that are not part of Engineering Tool.

Electronic Signature Electronic signature in PROCOS is intended to be used as a replacement for handwritten signatures on for paper documents, reports etc. It is in this context similar to the definition of "Digital signature" in "21 CFR Part 11": "Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified." "Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system." "Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature." Electronic signature applies to:

• Values being set by the operator in MIMIC
• Actions performed by the operator in MIMIC
• Alarms being acknowledged in ALARMDISPLAY
• Batch production
• Engineering in ENGTOOL