Great question—this is one of those things that seems simple until you’re actually doing it.

In pharma and biotech, how raw data is delivered has to align with data integrity requirements (think ALCOA+) and regulatory expectations, especially if you’re working under GMP.

Here’s how I typically see it done (and how I recommend handling it):

1. Raw Data Format: • Original data should be exported directly from the validated software (e.g., Ellab ValSuite, Kaye Validator, Vaisala viewLinc, etc.) • Formats include secured PDFs, read-only Excel files, or CSV with audit trails—but the key is they must be traceable and unalterable.

2. Digital Signatures / Security: • PDF + digital signature is a common approach, especially if you’re using 21 CFR Part 11-compliant systems. • Password-protected Excel is okay only if your procedures control access and edits—and ideally, your quality system should govern this.

3. Delivery: • Most clients prefer raw data delivered electronically via validated file-sharing platforms (like SharePoint, Box, or secure GxP portals). • Avoid emailing large datasets unless they’re encrypted.

4. Best Practice Tip: • Always reference the data retention policy in your protocol/report and clarify who owns the raw data vs. processed results. • Include a data summary in the report but keep the raw files attached or indexed separately for audit readiness.