fsma SaaS

Verification

Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine whether a control measure or a combination of control measures is or is operating as intended and to establish the validity of the food safety plan. 21 cfr 117.3

Verification

Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine whether a control measure or a combination of control measures is or is operating as intended and to establish the validity of the food safety plan. 21 cfr 117.3

Comparison - Foreign Supplier Verification Methods

Actionable requirements External Onsite Audit Sampling & Test Supplier food safety records by fsma SaaS fsma SaaS Advantages
Process flow chart Paper multiple checklists from independent departments Paper – multiple checklists from independent departments Digital in the cloud and available for scheduled download as one electronic document at point of use Applied manufacturing controls of related disciplines
Cost Collating paper records greater than $1 Significant $0 to Importer Least expensive for supplier and importer
Compliance Effectiveness Frequency of audits - annual– no assurance of completed desired controls Does not satisfy all verification requirements Ongoing compliance framework, which satisfies all FSMA requirements Risk of FDA Violation and reinspection fees minimized
Records - time to reach importer Delayed for collating documents Delayed for independent lab results Real time prior to shipping Supplier provides original records as is required by FDA
Media Paper by each discipline and function Paper by each discipline and function Digital -holistic integration of disciplines and functions Enables Management by Exception by Supplier, including denial of access unless trained
Risk of FDA violations Yes Yes No- Framework of Error proofing and alerts when scheduled activities are not completed Violations are not about the food, but compliance to FSMA.
Verification status FDA can find violations after External Audit completed – see 2020 violations FDA can find violations, even as sampling and test is accepted by importer 100% verification because of framework for on-going compliance Intuitive – no knowledge of the legal requirements – all FSMA requirements embedded in the technology
Manufacturing control Standalone disciplines with Paper are employee trust dependent Standalone disciplines with Paper are employee trust dependent Integrated Controls at point of use Digitizing the operations – enables controls and not trust dependent due to error proofing and alerts within the technology
Corrective action decision making (when to open) Delay or uncertainty on when to open a corrective action -takes a longer time to resolve Delay or uncertainty on when to open a corrective action – takes a longer time to resolve
  • Suppliers - Automated corrective action due to binary configuration and opened when conditions not met
  • Importer -Available box for checking each lot, if required

    Supplier- Alerts to management of corrective action required

    Importer- Provides earlier time for meeting 7 day response time limit after the non-conformance

    Traceability Manual input Manual input Ingredient Bar code scan at point of use or digital manual input Less risk of errors in recording bar code or manual digits
    Recall Manual Manual One click to all importers Digital enables recall response emails of the specific lot
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