Return to Top

 Introduction

On August 20^th 1997 the Food and Drug Administration made 21 CFR Part 11 effective.  This regulation is summarized as follows:

"The Food and Drug Administration (FDA) is issuing regulations that provide criteria for acceptance by the FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper recorders and handwritten signatures executed on paper.  Theses regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to promote and protect public health.  The use of electronic records as well as their submission to FDA is voluntary."

This guide provides details of the relevant sections of CFR21 Part 11and gives information on how the VR Series paperless recorders can be used to meet these FDA requirements for the creation of electronic records in a closed system.

Return to Top

FDA CFR21 Part 11 Subpart B, Section 11.10: Controls for modification

'Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and when appropriate the confidentiality of electronic records, and can ensure that the signer cannot repudiate the signed record as not genuine."

All process data recorded by a VR Series paperless recorder are in proprietary (tamperproof) format and read-only from normal operator interface.  Via the use of Historical Viewer data review software "digital signature" can be added and checked to validate the integrity of the data.  If any part of the data record is changed the Historical Viewer software will warn the user of the invalid nature of the record.

Digital Signature within Observer software

Return to Top

FDA CFR21 Part 11 Section 11.10 (b)

"The ability to generate accurate and complete copies of records in both human and readable and electronic form suitable for inspection, review, and copying by the agency (FDA)."

The VR Series Paperless recorders can create process data files on Compact Flash memory cards.  These data files are created from secure records stores in internal flash memory.  Error detection algorithms are employed to ensure that the stored data faithfully represents the actual raw measurements made by the recorder.  Each write to the archive media is also verified to ensure the integrity of the data record.  The archived process data files can be viewed using the Historical Viewer review software.  The data can be viewed and printed in graphical formats.  Standard spreadsheet formats (e.g. Microsoft Excel) of the archived data files can be created for viewing by users who do not have the review software.

Screen below depicts Observer PC Software pop up window stating data has been tampered

Historical Data View with Observer PC software

[white or black background, time frame, etc. configurable]

Export Historical Data files in .csv format

[Data can be archived, reviewed, etc., by users without access to Review Software [Observer]

Depiction of .csv file opened in Microsoft Excel®

Return to Top 

FDC CFR21 Part 11 Section 11.10 (c)

"Protection of records to enable their accurate and ready retrieval throughout the records retention period."

The VR Series paperless recorders use solid-state flash memory, for data storage, in the form of Compact Flash cards.  Data retention for this device is specified at a minimum of 10 years.  It provides Zero power data retention i.e. the data integrity is not dependent on battery back up.  The data is not affected by magnetic fields.  For longer term data storage the archive files can be copied to CDROM or to a network file server.

Return to Top