Putting data on the record

Developments in electronic data recording technology are offering new opportunities for the way in which data can be used. As well as recording the details of a production process, electronic data recorders are opening up a wealth of new possibilities for the way in which data can be analysed, presented and utilised throughout the organisation.

One such development is the addition of Ethernet communications. Last year, automation industry experts, the ARC Advisory Group, predicted that shipments of device-level industrial Ethernet products are set to grow by 84 per cent annually for the next five years despite difficult conditions in automation markets.

Ethernet's worldwide acceptance in industrial and office environments has created an eagerness to expand its responsibilities on the plant floor and beyond. Its performance capabilities make it ideal for tasks such as data monitoring and program maintenance.

Using Ethernet, operators can now remotely access and download information from electronic data recorders. This is particularly ideal for large sites using multiple recorders, or for applications where data may need to be collected from sites around the world.

With electronic data recorders, precise variations in process data can be recorded and displayed as required - or printed out as graphs and reports. Many suppliers can now also offer units that enable data to be downloaded into an Excel spreadsheet, allowing it to be interrogated in greater detail.

The validity of the recorded data is also greatly improved. Events can be automatically recorded together with the actual time they occurred, unlike paper chart recorders that rely on additional details being manually added to the chart by the operator.

Most electronic data recorders also now enable authorised operators to add an 'electronic signature' to recorded data to help in tracing who was involved in the process and any changes they may have made that might affect product quality. In the food and beverage and pharmaceutical sectors, the main concern in the take-up of electronic data recording technologies to date has been the security and integrity of recorded data.

There is the potential with electronic records for tampering by anyone with the requisite skills. For this reason, in 1997 the US Food and Drug Administration (FDA) introduced its 21 CFR Part 11 legislation, which sets out standards relating to data security and integrity that have to be met by electronic data recorders.

At the moment, the provisions of 21 CFR Part 11 apply specifically to the pharmaceuticals industry, although it is now starting to be increasingly adopted in the food industry as the need for traceability and validation of production procedures gains in importance.

The aim of 21 CFR Part 11 is to set out criteria by which electronic records and electronic signatures will be accepted in the place of paper records as proof of the validity of a manufacturing process. In particular, the regulations focus on three main areas - security, e-signatures and their validity, and management of the recorded data.

To protect against the risk of tampering, electronic data recording equipment must be capable of ensuring total security by preventing unauthorised access and indicating any changes made that could affect the validity of the production process.

This can be achieved in a number of ways. ABB's InformIT videographic recorders, for example, allocate all users with individual password and access rights, which allow them to be identified by the system and set restrictions on their ability to perform configuration changes that could affect the process.

Any alterations that are made are recorded by an internal audit trail, which logs the changes made and records who made the changes and when, as well as the details of all datafiles created and many other key events such as calibration changes. As verification that the correct procedures have been followed during production and to confirm any changes to configuration, 21 CFR Part 11 requires batch records to be electronically signed by a person with the relevant authority.

Again, ABB's videographic recorders have a user-specific password protected menu, from which the operator can elect to 'sign' for the data recorded by typing in a message. This 'signature' is then time-stamped and logged by the recorder to provide a traceable trail of all changes made, including when they were made and who authorised them.

Criteria for the way in which recorded data is managed and preserved is also set out by 21 CFR Part 11. Essentially, this criteria is geared towards preserving the same standards of data integrity as during the recording process and to eliminate the risk of unauthorised tampering or alteration of recorded data.

In the case of ABB's recorders, specialised analysis software is available that enables all data recorded to be downloaded for easy viewing and analysis. The security of data files created by its InformIT SM recorders is ensured by the use of binary encryption. Information stored on all of the recorders in the SM range can also be securely accessed via an Ethernet network. An embedded web server provides online access to web pages created within the recorder containing details of real-tme process data, which is also archived in a secure binary encrypted format. Another significant benefit of electronic data recorders is their ability to store and archive large quantities of data, particularly in industries where records have to be kept for several years.

Up to 2.8 million samples of data can be stored within a built-in 8Mb Flash memory and this can be archived to SmartMedia or Compact Flash memory cards or transferred to a PC. With just one 128Mb card being typically equivalent to kilometres of paper chart, the need for storage space is also eliminated - yet another of the many benefits of to be gained from today's electronic data recorders.

Martin Binney is a product manager with ABB.