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Process Authority Services
TechniCAL is the leading independent Thermal Process Authority in the world. We offer assistance to processors of Low Acid Canned Foods (LACF) and Acidified Foods in establishing processes and procedures for producing safe food products that are regulatory compliant. Services include Heat Penetration Testing of your products to establish a commercially sterile thermal process, Temperature Distribution testing of retorts, and Process Deviation evaluation. Our team of experts can assist you with any of your Process Authority needs.
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AUDITS / ASSESSMENTS
Compliance with FDA/USDA regulations is important for the safety of your products. TechniCAL can provide an on-site assessment of your compliance with the FDA/USDA canning regulations. We act either as an independent auditor or as part of your corporate audit team. Either way, TechniCAL can participate to help gauge facility compliance. Our audits are based on the most critical parts of these regulatory requirements. A complete report of our findings is provided upon completion. TechniCAL's team of experts know the regulations and can help you gain full compliance.
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Part 11 Validation Services
Retort systems that create and store electronic records and use electronic signatures are required to comply with FDA's regulation 21 CFR 11. Part 11 requires these systems to be validated that they comply with all provisions of the regulation. TechniCAL provides services to validate the retort system and confirm compliance with Part 11. Using NFPA Bulletin 43-L as a guide, we document the system specifications and then qualify on-site that the retort control system is operating as designed. Challenge testing ensures that the logic performs properly. We check the system for all requirements in Part 11, including user security, change control/audit trail, data integrity, and compliant format of electronic records. Our team of validation experts will work with you to ensure compliance of your retort control system with Part 11.