The evolution of 21 CFR Part11.

It would seem reasonable to assume that Part 11 was now understood, and was no longer the odious entity that the regulators, in the early days of enforcement, were predicting it would become once fully applied.  The clarification that the rule was to be applied to the existing regulatory required records structure only, was of great relief to some, and generally, of assistance to most regulated companies.  However from the forums you can still read opinions that are quite different.  Some of these opinions are quite adamant that Part 11 applies to data other than purely predicate rule required data, and the writers appear to be struggling to understand exactly what the difference is between electronic data and electronic records.

Sure, there is important and routine data that must be in place.  Data that must be properly structured, authorised, reviewed, approved, controlled and accessible to authorised persons, but these data requirements are detailed in other rules, mostly Part 210, 211 & 820.

In large automation systems where there can be many thousands of analog and digital inputs, the sensors outputs are normally processed and coupled through fibre optic networks into a control centre (which can be miles away).  At the control centre this sensor data is subjected to considerable processing to enable outputs to be available for use with (this is in no way a definitive list) integration modules (there are often many), operator visuals, control room visuals, alarm circuitry and history.  For diagnostic purposes the data can be accessed at various test points through the whole process.  All (designers, regulators and client) agreed at the design stage, that the data could be considered as ‘real time or raw’, all the way to the history unit.  Therefore, Part 11 compliance would be required for the history unit, and only the history unit.  The whole DCS does of course require a full life cycle validation program.

The most common source of predicate electronic data in the pharmaceutical industries is still the humble PLC, the majority of which are quite elderly, and use some format of ROM to store the data prior to downloading to a printer.  The ROM is refreshed at the end of the print cycle and no record is ever held in an editable format, so Part 11 does not apply. 

The interpretations given to Part 11 in its early days made compliance extremely difficult and very costly.  The most damaging of these was the refusal to allow dual systems to be used.  Your company had either to be 100% Part 11 compliant or remain 100% hard copy.   With the fresh interpretations that were published a couple of years ago, Part 11 integration has become a much simpler task.  However the original interpretations did tremendous damage and it is doubtful at this point in time, whether much more than ten percent of the industry is FULLY part 11 compliant.   

Alex Kennedy

Validation Online