MoCRA Compliance Evidence & Renewal Control System
Move from one-off evidence packets to an ongoing control system. The MoCRA Compliance Evidence & Renewal Control System organizes facility, product, submission, safety, adverse-event, recall, marketplace-evidence, and renewal records in one structured package.
DOWNLOADS IMMEDIATELY
A ZIP package containing:
• One editable Microsoft Excel workbook (.xlsx)
• One illustrated PDF user guide
• One README file with setup and use notes
Microsoft Excel is recommended. Other spreadsheet applications may alter formulas, data validation, conditional formatting, or layout. Product support questions can be sent to brent@synterasystems.com.
See the actual Dashboard, Facility Register, Product Register, Evidence Index, and Actions sheets in the preview gallery above. If you are answering only one marketplace request, start with the focused $39 Evidence Pack at https://synterasystems.com/mocra-marketplace-compliance-evidence-pack.
WHAT’S INCLUDED
• Dashboard
• Company & Roles register
• Facility Register
• Product Register
• Submission Log
• Safety Records
• Adverse Event Intake
• Serious Adverse Event Reporting control
• Recall Control
• FDA Records Request tracker
• Marketplace Evidence
• Evidence Index
• Action Log
• Sources & Scope
• Illustrated user guide
BEST FOR
Businesses managing multiple products, facilities, responsible-person relationships, or marketplace accounts; teams assigning owners for annual product-listing work, biennial facility renewals, amendments, safety evidence, adverse events, recalls, and records requests.
The system helps a team see what exists, what is missing, who owns the next action, when a record was last verified, and what date or event should trigger review. It supports human judgment and does not automatically determine exemption eligibility, product classification, filing duties, event seriousness or reportability, recall obligations, or marketplace acceptance.
Syntera is an independent operational-aid provider and is not affiliated with or endorsed by FDA or TikTok. The system is not an FDA certificate, FDA verification, FDA approval, legal advice, a filing service, an automated regulatory decision-maker, or a guarantee of compliance or marketplace acceptance. Users must verify their entries, maintain source records, apply current requirements to their facts, and obtain qualified advice where needed.