A defined process. A record you can follow.
How an engagement runs, from the first conversation to the handover: what Clearance does, what you provide, and how open questions stay visible.
The process, step by step
Start with the information you have and the question you need answered.
Understand the situation
Review the business, products, suppliers, existing records and any stated deadlines.
Agree the scope
Confirm the applicable work, required inputs, responsibilities, fees and timing in writing before work begins.
Develop the documentation
Prepare or review the agreed materials, distinguishing evidence, assumptions and open questions.
Review the record
Check completeness against the engagement scope and document unresolved items.
Plan the handover or ongoing support
Confirm access, ownership, review responsibilities and how future requests will be handled.
Who is responsible for what
The exact division of responsibility is set out in the scope agreed for each engagement.
Clearance
- Confirms the scope, and what it needs from you, before work begins
- Organizes and reviews the agreed materials
- Identifies sources and material assumptions in the documentation
- Keeps open questions visible and documents what is unresolved
You
- Provide the product, supplier and record information the scope requires
- Answer questions about your business and supply chain
- Make the decisions that belong to the importer or facility
- Keep your own records current once the engagement ends, unless ongoing support is agreed
What the work depends on
The information needed depends on the scope. These are the usual starting points.
Product information
What is imported or produced, and how it is described in existing records.
Supplier information
Who supplies what, and the documents you already hold about each supplier.
Existing records
Any program documents, plans or prior correspondence that bear on the question.
Dates and communications
Any stated deadline, and any FDA communication that prompted the request.
Contacts and access
The people who can answer questions, and how documents will be shared.
How the record is reviewed and updated
Documentation is checked against the agreed scope before handover, and anything unresolved is listed rather than left implicit.
How updates are handled after handover, for example under ongoing support, is agreed separately so both parties know what is included.
Discuss the scope.
Tell Clearance about your products, your role in the supply chain and the support you need. Include any relevant deadline. Clearance will review the inquiry and confirm whether the request fits the support available.