Wonderware has announced that its FactorySuite 2000 automation software family, including the InBatch batch processing module and the IndustrialSQL Server real-time database, is in compliance with the US Food and Drug Administration (FDA) Code of Federal Regulations (21CFR Part 11) concerning the use of electronic records and signatures for batch management systems.
‘The FDA and the pharmaceutical industry have worked together since the early 1990s toward a new regulation that would allow computer and software technology to be used for electronic records and signatures in lieu of maintaining paper copies and handwritten signatures for production records,’ said Larry LeBlanc, Wonderware’s director of marketing for batch solutions (picured).
‘Wonderware has been monitoring the FDA activity and working closely with our pharmaceutical customers to make sure we were compliant when the regulation was approved in 1997,’ LeBlanc said. ‘There is some degree of interpretation involved and our pharmaceutical customers helped us design InBatch to be compliant. It was obviously beneficial to them and to us. Since then InBatch has been used in many FDA approved applications.’
Prior to 21CFR Part 11, every master production and control record had to be dated and signed with a full hand-written signature, then independently checked, dated and signed by a second person. The ratification last year of the Electronic Signatures in Global Commerce Act, which now provides legal status for all electronic signatures, has prompted the FDA to intensify the enforcement of 21 CFR Part 11.
‘The FDA clearly is concerned about fraud, since electronic data sets and signatures could be falsified or altered,’ LeBlanc said. ‘Database elements could possibly be changed at any time to misrepresent information, without leaving evidence that a change was made and in a manner that destroys the original data. The FDA also is concerned that more people might have access to electronic records than to paper records.’
InBatch and IndustrialSQL Server provide security features that address the FDA issues. FactorySuite can require up to two levels of security on any function in the system. Only those users who have been assigned a security level equal to the function can access this function.
InBatch logs any changes made by operators and appends them to existing historical records. The software does not permit anyone to change the original data. So even if an authorised individual appends data, it creates an audit trail with time stamps. InBatch also ensures that batch recipes are executed as designed, guaranteeing that the intended sequence is followed, and maintains audit trails of each event in the sequence.
Occasionally there are changes or exceptions to the procedure. InBatch covers this requirement by logging all deviations to batch history. The system also always refers to users by their names, not their user IDs, which prevents other people from obtaining anyone’s user ID. Passwords are never displayed, transmitted or stored without first being encrypted.
‘It should be noted that obtaining FDA approval is accomplished one application at a time,’ LeBlanc said. ‘If a company is using electronic records and signatures, then the FDA will check to ensure that individual procedures and software applications comply with 21CFR Part 11. This means that it’s impossible to purchase 21CFR Part 11 software that is ‘approved by the FDA’ – but working with software from companies that have been scrutinised and whose customer applications have passed the FDA process is a good place to start.’