VIXAR Enterprise Compliance Platform

Step 1 of 6

Name the file and decision.

Name the site and decision first. Then answer the first check.

Name or operator handle Email Role Company Site / product / program

What are we checking?

Decision type Systems involved

Can you pull the record fast?

If an FDA investigator asked for your last 10 deviation investigations right now, could you pull them from one system without assembling them from people, spreadsheets, or memory?

YesThe record stands in one place already. NoSomeone still has to assemble the answer.

Step 2 of 6

Do the systems agree?

If QMS and CMMS were read at the same time, would they describe the same operational reality without a person stepping in to explain the mismatch?

YesThe systems agree on the state. NoA person still has to explain the mismatch.

Step 3 of 6

Is anything being manually held together?

Is there a condition in the operation right now that needs active management to stop it from becoming a regulatory finding?

YesThere is a live condition being manually held together. NoNo active condition needs manual containment.

Step 4 of 6

Can the validation decision be traced?

If FDA asked to trace the decision authority behind your last major validation conclusion, is that trail complete without explanation?

YesThe record speaks for itself. NoSomeone still has to narrate the record.

Step 5 of 6

Do closed issues stay closed?

In the last 12 months, has any deviation come back after it was already closed as resolved?

YesA closed issue has already come back. NoClosed issues are staying closed.

Step 6 of 6

Could this survive an inspection today?

Could the operation survive an unannounced FDA inspection today without preparation, coordination, or narrative support from the team?

YesThe daily state can survive scrutiny as-is. NoThe team still depends on preparation or rescue narrative.

TargetNot answered yet

Record pullNot answered yet

System matchNot answered yet

Live riskNot answered yet

Validation trailNot answered yet

Repeat issueNot answered yet

InspectionNot answered yet

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