Resources
Practical guides on regulatory and quality topics for FDA-regulated professionals — written to answer real questions, not to promote a specific event.
Computerized Systems Assurance: A Practical Guide for Regulated Teams
Computerized systems sit inside many regulated workflows. The compliance question is rarely just whether software works — it is whether the organization can demonstrate the system is fit for its intended use and that its records can be trusted.
FDA Warning Letters: What They Reveal About Computerized Systems
FDA warning letters show where a real inspection found gaps in a firm’s controls. Read as recurring themes rather than a checklist, they can help quality and IT teams identify the questions worth asking before an inspection.
SaaS & AI Change Control: Keeping Validated Systems Under Control
Modern SaaS products change continuously, and AI-enabled systems may change through models, prompts, data pipelines, configurations, or vendor updates. The challenge is preserving control without turning every routine change into an identical validation project.
Nitrosamines and ICH M7: Practical Questions After an Initial Assessment
Nitrosamine risk assessment is not a one-time checkbox. Changes in synthesis, raw materials, suppliers, processes, or formulation can create a need to revisit assumptions and determine whether a reassessment is appropriate.
Computer Software Assurance vs. Traditional Computer System Validation
CSA is not "less validation." It is a different way of deciding how much evidence a given system actually needs, and where to spend the effort that traditional CSV often spread evenly across everything.
How to Prepare for an FDA Computerized-System Inspection
Being validated and being inspection-ready are related but different: an organization can have real validation evidence and still struggle to retrieve, organize, or explain it when an investigator actually asks.
AI/ML Software Governance for Regulated Organizations
Change control answers "how do we handle a change to this AI component." Governance is the broader question: who is accountable for this component’s behavior over its whole lifecycle, and how is that monitored.
Root Cause Analysis and CAPA Effectiveness in GMP Investigations
A CAPA that closes on schedule but doesn’t stop the deviation from recurring hasn’t actually corrected anything — it has documented a correction.
ISO 14971 Risk Management for Medical Devices: A Practical Overview
ISO 14971 is a lifecycle risk-management standard, not a one-time design review — and AI/ML-enabled devices raise risk questions the standard’s original drafters did not have to consider.