> Creating Electronic Records and Signatures

Datastream 7i allows you to create electronic records, or "snapshots," of events that occur in the database. A snapshot preserves the entire record, including information related to other database tables, to provide historical information related to the progress of your operation. For example, a snapshot of a work order header will include all information on the header as well as the associated activities. Datastream 7i also provides the ability to print and export snapshots to external formats such as Adobe Acrobat Portable Document Format (.PDF).

In addition to creating electronic records of information in the database, you can set up Datastream 7i to require an electronic signature to authorize status changes to specific records. The electronic signature is attached to an entity, and when a Datastream 7i user changes the status of a record based on specific criteria, Datastream 7i prompts the user for an ID, password, and a reason for the signature (e.g., review, approval, responsibility, etc.).

You can also select to associate certifications with electronic signatures to facilitate the proper authorization of status changes by requiring authorized users to enter a certification number and certification type when entering their signature, which is required by the Federal Aviation Administration (FAA) for electronic signatures. The FAAMOD installation parameter determines whether you are required to enter a certification number and certification type for electronic signatures. If FAAMOD is set to ON, Datastream 7i displays Certification number and Certification type on the Electronic signature dialog box and you must enter a valid certification number and type to sign the record. Certification numbers and types are associated with qualifications for employees on the Qualifications tab of the Employees form (WNPERS).

Certification types are associated with the CRTP entity, for which you must define qualification codes as user codes on the Entities form (BNENTS).

If you have configured comments for entities for which you are creating electronic records and signatures, Datastream 7i includes any comments entered for a record associated with that entity in the electronic record. Including comments in an electronic record enables you to maintain a more complete record of any critical information related to an electronic record/signature that is entered as a comment. Comments for electronic records are printed on the Electronic records report (BRSNAP).

Refer to the following topics for information on creating electronic records and signatures.

Defining Entities for Electronic Records and Signatures

Configuring Electronic Records and Signatures for Current Good Manufacturing Practices (cGMP) Equipment

Signing Records

Viewing Electronic Records and Signatures

Generating Reports for Electronic Records