Medical Device Link.

Originally Published PMPN November 2002

REGULATORY FOCUS

FDA's draft guidance addresses the maintenance of electronic records.

Erik Swain, Senior Editor

A new draft guidance from FDA outlines how manufacturers of drugs, medical devices, and other FDA-regulated products should maintain electronic records and signatures related to their packaging and other operations.

The document, "21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records," was issued in late August 2002 and published in the September 5, 2002, Federal Register [67 FR:56848–56849]. FDA is accepting comments on the draft until December 4, 2002.

The new guidance does not cover everything about maintaining electronic records, but it outlines some key principles and practices for companies to follow. It applies to the entire required record-retention period, regardless of how often the records are used or accessed.

Firms maintaining electronic records need to employ and update procedures and controls for their protection and to make the records more retrievable. Procedures should describe how the records will be maintained, what the storage conditions and precautions are, what the retrieval and access restrictions are, which approach to long-term storage is being used, and who is responsible for which tasks.

Factors that could affect the reliability of the records during their retention must be identified and controlled. These include hardware, software, encoded data, data dictionaries, and other metadata—the media used to record the data, and the process of presenting the information in human-readable form.

Companies should get into the practice of periodically accessing a representative number of records just to make sure they can still be read and evaluated throughout the retention period. They should consult the suppliers and producers of the electronic recording media they are using about how frequently this should be done. If degradation occurs, the records should undergo recovery procedures or be transcribed onto fresh recording media before they become irretrievable. The most important records should be backed up, and the backup copies should be stored separately from the originals.

Suppliers and producers of recording media should be consulted on storage concerns such as temperature, humidity, dust, vibration, and electromagnetic and radio-frequency interference.

The ability to process a record's information throughout the record retention period needs to be preserved. Features on an original record, such as searchability or sortability, should be maintained on the copy.

The agency wishes to prevent information from being lost or altered during the copy process. A built-in copy verification mechanism is recommended to prevent inaccurate or incomplete copies from being made. If no such system is in place, the copy process must be validated.

The draft guidance suggests two approaches to the maintenance of electronic records: the time capsule approach and the migration approach.

The time capsule approach preserves the record on the same electronic media and computer system where it was first created. The computer system must be kept functional throughout the retention period, and no changes or upgrades to the computing environment may be made. System documentation must be preserved, and personnel must be trained on system operation and upkeep. Although the agency does not recommend this approach in general, it is appropriate in some cases, such as when record retention periods are short, or maintenance of the original system is inexpensive.

The migration approach involves moving records from one computing system to a newer one. The migration must be documented to produce a traceable history of what systems were used throughout the records retention period. After a migration, the old system may be discarded only if the migrated records meet all applicable requirements, though firms should give careful consideration as to whether future problems will be more difficult to solve if the old system no longer exists.

The migration must be planned and conducted carefully. The migrated record must convey an accurate and complete representation of events, data, actions, identifications, and signatures, as required. Factors in the new computer system that enable reliable preservation and presentation of the information should be identified and controlled. The integrity of the record should be preserved, so when a migration transforms an old record into a new one it is reflected in the audit trail. The new system must ensure that signatures cannot be excised, copied, or otherwise transferred, which could be used to falsify an electronic record. Unavoidable differences in and losses of information must be accounted for and explained.

Written comments on the guidance can be sent to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Rm. 1060, Rockville, MD 20852. Electronic comments can be submitted at www.fda.gov/dockets/ecomments.

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