This technical note has been compiled by Allpax based on written and verbal communication with regulatory personnel from CFSAN (FDA’s Center for Food Safety and Applied Nutrition), regarding the current status of 21 CFR Part 11 as applied to the Allpax Retort Control System. This is an Allpax-generated document that has been issued to its customers to provide technical information that can be used by the plant to respond to requests relating to 21 CFR Part 11, and the system control on your retorts.
Categories – For Your Allpax Retort Control System
A Retort Control System will fit into one of three categories, and will be categorized based on two of the following tests: (1) when the Allpax system was installed in your plant, and/or (2) how the records produced by the system are used by the plant
Based upon the two variables, the system will fall into one of the following three categories and will be evaluated by FDA based on the category:
1) A RECORD-PRINTING SYSTEM
If the system was installed after the introduction of 21 CFR, Part 11, on August 20, 1997, the system may be used as a record-printing system. If the system is being used to generate the process records immediately after the process (as the Allpax system does), and those records are being used as the official retort process records, then the system does not have to be in compliance with 21 CFR Part 11. It is important to note that records stored on the system CANNOT be later printed and used as the official record, nor used to make any regulatory decisions. If the system is being used in this capacity, then the system must be in compliance with Part 11. Note the guidelines and tests given below in the FDA’s Guidance for Industry, Part 11, Electronic Records; Electronic Signatures – Scope and Application, August, 2003:
“Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities. In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies. Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).”
The following is an interpretation of the guideline by CFSAN personnel regard-ing the use of the system as a printer:
Any system that is printing the process records out at the end of the process (or sometime shortly after the process cycle) and is using this printed record as the record required by 21 CFR 113/114, the system (equipment/computer) used to generate the record is immaterial and the record generation system does not need to be in compliance with part 11.
As you talk to your clients you might want to specifically spell out to them how this guidance affects your system and that any use of the electronic records for regulatory decisions would require that the system be in compliance with 21 CFR 11. Only when the printed records are use to make ALL regulatory decisions would your system be exempt from 21 CFR 11. However, the processor can use the electronic data for any other activity such as quality control decisions and product production issues, etc.
It is our understanding that your system is functioning in this capacity. As long as your system prints out the permanent record at the end of the process and the processor uses this printed record for ALL regulatory decisions and for compliance with 21 CFR 113/114, or until such time that the guidance document is retracted, your computerized control system does not need to be in compliance with 21 CFR 11. Since the system is not creating an electronic record for purposes of compliance with 21 CFR 113/114.
2) A LEGACY SYSTEM
If your Allpax system was installed prior to the introduction of 21 CFR, Part 11, August 20, 1997, and it meets the other conditions noted below, it is considered a Legacy System and does not have to be in compliance with 21 CFR, Part 11. Note the guidelines and tests given below in the FDA’s Guidance for Industry, Part 11, Electronic Records; Electronic Signatures – Scope and Application, August, 2003:
“The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11, under the circumstances specified below.
This means that the Agency does not intend to take enforcement action to enforce compliance with any part 11 requirements if all the following criteria are met for a specific system:
- The system was operational before the effective date.
- The system met all applicable predicate rule requirements before the effective date.
- The system currently meets all applicable predicate rule requirements.
- You have documented evidence and justification that the system is fit for its intended use (including having an acceptable level of record security and integrity, if applicable).
If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance.”
The following is an interpretation of the guideline by CFSAN personnel regarding Legacy Systems:
What this means is the processor would have to have had a system in place generating an electronic record in agreement with 21 CFR 113/114 before Aug. 1997 to have a legacy system. If there are any systems in place at this time that where installed before Aug 1997 and are still operating without any changes to them they would be considered a legacy system. If changes were made to the system that affects the systems ability to be in compliance with 21 CFR 113/114 it would not be considered a legacy system. Any system installed at the processor after Aug. 1997 would not be a legacy system.
3) A PART 11 SYSTEM
If your retort control system is not a Legacy System, or it is being used beyond the function of a record printing system, then it must be in compliance with 21 CFR, Part 11, as specified in FDA’s Guidance for Industry, Part 11, Electronic Records; Electronic Signatures – Scope and Application. August, 2003.
History of the Allpax Retort Control System
The Allpax Retort Control system was developed in 1990. In 1991, Allpax requested that the USFDA accept the electronic records produced by the Allpax Retort Control System in place of the manually generated records. From 1991 through 1993, Allpax voluntarily submitted its system to FDA for audit and review. After a series of presentations in Washington, DC and on site visits to customer sites by FDA regulatory personnel, the Allpax Retort control system was accepted as a system that met the intent of 21 CFR and provided safeguards that satisfied FDA’s concerns. See the February 13, 1993, letter from the Director of Field Programs, CFSAN (Center for Food Safety and Applied Nutrition), USFDA, to Mr. Steve Hudson, then President of Allpax.
The Allpax Retort Control System Relative to 21 CFR PART 11
The Allpax Retort Control system is a software product developed by Allpax Products, Inc., of Covington, LA. The Allpax Retort Control system (marketed under the trade names for product modules of Pax-Ware, AllView, AllLog, and MoNiTor). The Allpax Retort Control System has kept pace with the technological changes over the years. While its original version consisted of software developed for a PLC-based application, the current versions of Allpax include both PLC and VLC platforms. The same features that were present during the 1991 submission to USFDA remain in place, while new features have been added. As required, Allpax has taken the appropriate measures to keep USFDA notified of these changes.
Although the Allpax Retort Control System can be used as solely a record printing system, and has been installed in numerous facilities prior to Part 11 (rendering it capable of being classified as a Legacy System, some of our customers have required that our package withstand Part 11 Validation. As a result, features have been added to provide the customer with additional record security, electronic signature enhancement, record fingerprinting, transportability of records for review, and other functions needed for Part 11 compliance. These features are available in Version 4.0.0 of the Allpax Retort Control System. For a comprehensive review of the features and functionality of the Allpax Retort Control System as applied to Part 11, see Allpax System Response to 21 CFR Part 11.
The quoted information contained in this technical note was provided as a result of conversations and correspondence with:
- Mr. Steve Spinak, Division of Field Programs, FDA
- Dr. John Larkin, Process Engineering Branch, FDA