Manufacturers - 2

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period, it may not be necessary to copy all of the records that show this recurring deviation. Several examples can be collected, and the extent of the deviation fully explained in the inspection report. When the time period of the process failure can be bracketed collect copies of the records of the first and last occurrence and several examples in between those dates.

COMPUTER GENERATED
RECORDS

In the early 1980's Central Analytical Laboratories, Kenner, LA. (now known as TechniCal) introduced their LOG-TEC Retort Management Systems which included, in addition to computer control of the retort, the ability to calculate a new process if process temperature drops occurred; and computerized record keeping. The LOG-TEC system is a full distributed system, using a controller for each retort that gets its instructions from a centrally located "host" computer capable of storing and downloading hundreds of different processes. Once a process is underway the retort controller operates independently and is capable of completing a thermal process and storing the information. The system was advertised as eliminating the need for manual record keeping.

In November 1983 New Orleans District requested CFSAN review of the record keeping functions of this system and its compliance status in regard to the lacf regulations. With additional input from Central Analytical Labs, CFSAN review determined the computer was equivalent to a person for the entry of processing information to the LOG-TEC system; and the design of the LOG-TEC system was found to meet the overall intent of the regulations, and appeared to provide safeguards which were sufficiently equivalent to the safeguards provided by the mandatory provisions of the regulations. This conclusion was transmitted to the firm in a letter in June 1984. The CFSAN did not object to the use of an resistance temperature device (RTD) to start the process timing, as long as a comparable MIG thermometer reading was taken at 2 minutes into the process and added to the computer record by the operator. FDA suggested, and Central Analytical Labs agreed to provide detailed instructions of how the computer based retort control and record keeping system worked to each of the firms using the system. This information was also to be made available to FDA Investigators inspecting those systems.

In determining the compliance status of this system CFSAN used a three phase approach including: a visit to FDA by the vendor of the system to explain the system to FDA; a visit by FDA Investigators/ Computer Specialists to the vendors location to review software and system development, documentation and validation; and a visit by FDA Investigators/ Computer Specialists to a commercial facility to evaluate the computer based retort system under actual operating conditions.

It must be emphasized that FDA is not 'approving' this system or the other two referenced in this section; rather it is acknowledging that the systems, as designed and operated, are sufficiently equivalent to the operation of manual, semi-automatic, and other fully automatic control systems that were in existence at the time the regulations were finalized. FDA determines whether the intent of the regulations, particularly the requirements of 21CFR 100(a), are being met with these computerized systems.

Since the review of the LOG-TEC system FDA has reviewed 2 other systems; the Allpax system and Stock America's, Icon 2000 system.

The Allpax Products Inc, ( Mandeville, La.) system is a computer based retort control and record keeping system. The Allpax computer control system is able to operate in a stand alone mode, where a Program Logic Controller (PLC) controls the process but the operator makes a written record, or in a "host" computer mode where a Personal Computer (PC) is used to capture and print processing records. The PC is also used to store thermal processes and to program the PLC's at each retort location. The Allpax computer controlled system differs from the LOG-TECH system in that the Allpax system does not calculate new processes in the event of a process deviation; instead the Allpax system chooses an alternate process from a preprogrammed table of alternate processes. The Allpax system can be programmed to select the thermal process based on the initial temperature supplied to the computer.

After FDA performed a three phase review, as outlined above, in February 1993, FDA informed Allpax this system met the intent of the lacf regulations. However, one condition FDA stipulated was that a detailed description of the computer control system be provided to each firm using the Allpax retort control system, and that such information be available to FDA investigators inspecting these plants.

In March 1993 the first phase of FDAs review of Stock America, (Milwaukee, Wi.) "Icon 2000" computer control and record keeping system, designed to capture and record processing information, took place. Operator inputs are required for items such as the MIG thermometer readings,

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