21 CFR 11 compliance

The development and widespread adoption of electronic record-keeping and electronic signatures has created unprecedented security challenges for the maintenance and integrity of batch histories in regulated industries. The US Food and Drug Administration's (FDA's) recent Code of Federal Regulations Number 21, Part 11 (21 CFR 11) defines the criteria under which the FDA will accept electronic records and electronic signatures as equivalent to paper-based records and handwritten signatures, in relation to all pharmaceutical and food and some chemical products sold in the USA.

The 21 CFR 11 criteria are designed to prevent accidental alterations to electronic records, deter deliberate falsification, and help detect such changes when they do occur. Organisations that use electronic records and signatures are required to have standard operating procedures (SOPs) in place that complement and support the relevant features of their instrumental analysis systems. Inevitably it is the users of such systems who are finally responsible for 21 CFR compliance. However, compliance can be supported by instrumental analysis systems that include protocols and checks for collecting, manipulating, presenting and archiving batch data.

Compliance with 21 CFR 11 is now necessary for all Australian pharmaceutical, food and chemical manufacturers who wish to continue to export to the US market. Given the absence of any previous standardised approach, it seems likely that 21 CFR 11 will set new benchmarks worldwide.

Process automation company Endress+Hauser is focused on providing its customers with systems and training programs that will help them achieve and maintain 21 CFR 11 compliance as smoothly, easily and affordably as possible. The validation master plan (VMP) of the Endress+Hauser 21 CFR 11 Working Group is providing a global strategy to meet this aim and drive future developments.

Endress+Hauser has already released a secure data manager that provides comprehensive support for 21 CFR 11 compliance. The Memograph S provides an audit trail that makes process sequences verifiable by plotting signals, monitoring alarm limit points, analysing measurement points, storing data internally and archiving data on ATA flash memory cards in a coded format. Data access is limited to authorised personnel and is controlled by use of a unique ID and password system.

Memograph S has a stainless steel front cover with an unbreakable plastic window and a tamper-proof rear panel. Its process-dependent alarm setpoints make the unit especially useful in multi-product plants, the pharmaceutical and food industries, biotechnology, and for monitoring CIP cleaning systems and batch applications. Memograph S is compatible with serial interfaces, ethernet, modem and Profibus DP, and also acts as a long-term monitor providing easy access to historical data.