Describe the protocol in a summary that explains its proprietary elements without disclosing them, attach the version history and training records, and offer the full document for inspection if requested. Confidentiality is a reason to summarize, not a reason to leave the evidence out.
Evidence that proves knowledge without exposing the method
Prepare a two-to-three-page description of the protocol: its purpose, the stages it covers, what distinguishes it from published validation guidance, and how it connects to the company's quality system. Redact numeric criteria and formulas. Attach the document control record showing version numbers, dates and the applicant's role in each revision.
Add training rosters listing the staff she has trained, internal audit reports that cite the protocol by name, and any accreditation correspondence that references it. Include a letter from the laboratory director explaining how long a newly hired scientist would take to become proficient and what parts of the protocol are undocumented institutional knowledge. Provide the US laboratory's current procedures so the examiner can see the gap the transfer is meant to close.
If the examiner asks for the unredacted protocol, respond with a confidentiality request rather than refusing.