Issuance Date: May 31, 2011
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Vigilistics, Inc. vEMI CIP Compliance Reporting System (Including Product Storage and Filtration)
The Vigilistics, Inc. vEMI CIP Compliance Reporting System is an electronic collection, storage, and reporting system for CIP records; raw and heat-treated product storage tank’s temperature and cleaning requirements; and temperature monitors for membrane filtration.
In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guideline for Evaluating Construction, FDA’s Pacific/Southwest Regional Milk Specialists and CFSAN’s Dairy and Egg Branch/Milk Safety Team have specifically evaluated the Vigilistics, Inc. vEMI CIP Compliance Reporting System and have validated and confirmed the technical information submitted by Vigilistics, Inc. and the review findings of the Pacific Southwest Region Dairy Equipment Review Committee (PSRDERC).
When the Vigilistics, Inc. vEMI CIP Compliance Reporting System is installed, used and maintained in accordance with submitted documents for the electronic collection, storage, and reporting of CIP records; raw and heat-treated product storage tank’s temperature and cleaning requirements; and temperature monitors for membrane filtration the Compliance Reporting System has been found to meet the applicable provisions of Items 12p-Cleaning and Sanitizing of Containers and Equipment, 16p-Pasteurization and Aseptic Processing (related to temperature monitors for membrane filtration) and 17p-Cooling of Milk and Milk Products; and Appendix H-Pasteurization Equipment and Procedures and Other Equipment (related to electronic data collection, storage and reporting) of the Grade “A” Pasteurized Milk Ordinance (PMO).
Compliance with the PMO is based upon installation, use, and maintenance as described in the following provisions:
- Customers or vendors installing the Vigilistics, Inc. vEMI CIP Compliance Reporting System must protect the database server with a Uninterruptable Power Supply (UPS) providing twenty (20) minutes of electrical power in case of a power failure.
- The customer’s facility is instructed to maintain a written record (log) of the changes and updates to the Vigilistics, Inc. vEMI CIP Compliance Reporting System. Maintenance and Information Technology personnel should be trained on the devices, computers, servers, and software that require this log, and the procedure for recording changes. This documentation of change control is instructed to be a separate record and must be available for review by the Regulatory Agency and the FDA.
- On initial installation, the installer is instructed to print all reports for seven (7) consecutive days to assure that the system is functioning accurately and error free before it becomes a compliance reporting and records system. The installer must correct any anomalies before this seven (7) day period, and furnish a signed copy to the customer, or a cover letter with their signature to assure that the system is functioning accurately and error free. These seven (7) days of reports shall be kept on file at the milk plant and a copy shall be provided to the Regulatory Agency and FDA when requested.
- The customer is instructed that when changes, updates, or anomalies are observed, they should be investigated and corrections should be addressed. These investigations and corrections will be recorded and signed by the person performing them.
- The milk plant must have a procedure to back-up the database for the Vigilistics, Inc. vEMI CIP Compliance Reporting System every twenty-four (24) hours.
The technical information that was submitted and reviewed addressing the Vigilistics, Inc. vEMI CIP Compliance Reporting System constitutes the PSRDERC's Engineering Design and Technical Construction File (EDTCF) PR-11-01. The material in the EDTCF is the property of the manufacturer and may be shown at their discretion.
For additional information regarding this compliance reporting system, and to request copies of the documents listed, please contact:
Irvine, CA 92618
Attn: Craig Nelson
Phone: (949) 433-1401
FDA’s review and acceptance of the Vigilistics, Inc. vEMI CIP Compliance Reporting System does not constitute FDA or State Regulatory Agency endorsement or approval. Any representation on a label or in printed literature citing or indicating as “FDA Approved” would be considered as false and misleading.
An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory/Rating Agencies and State Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web Site at http://www.fda.gov at a later date.
If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.
FDA Regional Dairy Specialist
CAPT Robert Hennes
FDA/DEB Milk Sanitation Officer
Attachment: EDTCF Table of Contents