Computer System Validation Protocol: The V-Model Paper Trail
A CSV package is a connected chain of documents following the V-model, not one “protocol.” The full deliverable set, and the matrix that ties it together.
FDA Guidance on Computer System Validation: CSV to CSA
Computer system validation is governed by a connected arc of FDA documents, not one — reading the shift from exhaustive CSV to risk-based assurance (CSA).
21 CFR Part 11 for Excel Spreadsheets: The Missing Controls
A native spreadsheet isn’t Part 11 compliant, for structural reasons. Why Track Changes isn’t an audit trail, and the controls a spreadsheet can’t provide.
21 CFR Part 11 Checklist: A Section-Referenced Self-Audit
A section-by-section Part 11 self-audit with exact subsection references, a pass/partial/fail column, and break-out checklists for the controls teams miss.
21 CFR Part 11 Compliant Software: Vendor Claim vs. Reality
“Part 11 compliant software” is a vendor claim, not a switch you can buy. What vendors actually ship, and the configuration, validation, and SOPs you own.
ICH E6(R3): What Actually Changed, and What to Do About It
E6(R3) is a structural rewrite of GCP, not a touch-up. What changed — risk-based quality management, essential records, monitoring — and what to do next.
Computer System Validation: A Plain-Language Guide
Computer system validation is documented evidence that a system does what it’s specified to do — a risk-and-evidence discipline, not a paperwork ritual.
ICH GCP Guidelines: The 11 Principles as an Operating Model
ICH GCP isn’t a checklist to pass an inspection — it’s an operating model. The 11 principles of E6(R3), read as how to think about a trial, not boxes to tick.
Audit Trail Example: An Annotated Record, Field by Field
An audit trail answers who, what, when, and why for every change. A real annotated example, field by field, and what separates it from an ordinary log.
ALCOA Principles: An Accountability Map for Data Integrity
ALCOA isn’t a glossary to memorize — it’s an accountability map. For each attribute, who owns it on a trial and the data-integrity failure it prevents.
21 CFR Part 11: A Conditional Rule, Not a Checklist
Part 11 is conditional: it bites only once a predicate rule applies. What’s actually in scope, and why “compliant software” is a claim, not a switch.