A sign of the times

Sign on the dotted line. Signatures are here to stay but not just as a written record. Tracking actions and events requires vigorous audits for accountability and traceability of electronic data in batch production. Three years after implementation, the US Food and Drug Administration (FDA) is forcing compliance with the 21 CFR Part 11 regulations. According to the FDA, the pharmaceutical and food industries have had enough time to bring their systems and processes into line.

So how are you going to fulfil FDA requirements and avoid incrimi-nating warning letters? Leading software vendors have been preparing for the regulations. Intellution has hired Stelex, a leading consulting firm, to evaluate and audit its products to ensure that they match the regulations' requirements. Intell-ution explained that software already installed in pharmaceutical systems needs to be brought up to date in order to comply with the regulations.

Don't look back

The way in which software was initially installed could mean that the problem of compliance could be compared to the sweat and toil of the Y2K rollover. The task may seem daunting, but as a starting point, the requirements for electronically signed operations should be the same as for current paper records. In fact, 'the FDA does not require pharmaceutical companies to keep and submit records electronically, but the vast majority of companies are using such systems,' said Dan Matlis, director of sales and marketing at Stelex.

In collaboration with industry, 21 CFR Part 11 was developed over a period of six years and is consistent with commercial standards and practices. A complete audit trail of all human interactions with batch production records, such as data entries, modifications and deletion, are maintained as a separate database. According to Ian Pepper, of Autom-soft: 'the ability to run two independent databases is a big security advantage, as the audit database can be completely isolated from the process and batch database.'

Fisher-Rosemount has released DeltaV 5.3 to improve batch performance. Significant batch enhancements include support of the FDA regulations. Campaign Manager secures batch operations by automatically requiring a user name and password. An electronic signature can be requested as confirmation as well as a secondary signature for verification for Batch Operator Interface actions, as a response to operator prompts. These signatures are stored, along with the action that was performed, as part of the batch's history.

Plantscape from Honeywell is designed as an integrated system, which provides a high level of scaleability. 'The system gives a one reaction vessel across the whole pharmaceutical site,' said Chris Morse, application consultant at Honeywell. For monitoring batch production, the system uses double signatures with passwords and swipe cards. 'But for the big pharmaceutical companies Plantscape is not suitable for retrospective implementation,' said Morse.

According to the Industry Coalition on 21 CFR part 11, compliance with the regulation should be required only as applications need to be replaced or upgraded as part of their normal life cycle. For the majority, this would typically occur over a 5-7 year life cycle. In addition, certain controllers, such as PLCs, lack the ability to generate audit trails or extract data to external files and should be treated in the same way.

As warning letters go out to companies across the world following detailed inspections by the FDA, the answer seems to be, to show willing. For example, a detailed implementation plan would need to be updated periodically to reflect incremental improvements.