Validation & CompliancePharma
Computer System Validation for eClinical Systems: A Working Guide
A working guide to validating eClinical systems: scope, risk assessment, documentation, and the split between…
13 min read
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Latest Articles
Showing 1–12 of 33
Validation & CompliancePharma
Validating AI and Machine Learning Features Under GxP
Non-deterministic outputs break test scripts. How to define intended use, bound the risk, monitor drift and…
11 min read
Validation & CompliancePharma
Data Integrity and ALCOA+ in Clinical Data Workflows
ALCOA+ is easy to recite and hard to evidence. What each principle demands of a real EDC-to-export workflow…
9 min read
Validation & CompliancePharma
Validating a SaaS eClinical System: Who Does What
Your vendor validates the product. You validate your configuration and your use of it. The responsibility…
10 min read
Validation & CompliancePharma
Audit Trail Review: Writing a Procedure That Survives an Inspection
An enabled audit trail with no documented review is a finding waiting to happen. How to scope, schedule and…
9 min read
Validation & CompliancePharma
From CSV to CSA: What the Assurance Approach Changes in Practice
Computer software assurance shifts effort toward critical thinking and away from scripted testing. What that…
10 min read
Validation & CompliancePharma
Annex 11 and 21 CFR Part 11 Side by Side
Annex 11 and Part 11 overlap, but diverge on supplier assessment, risk management and periodic review. What…
9 min read
Validation & CompliancePharma
21 CFR Part 11 Compliance: What Inspectors Ask to See
Part 11 applies to how you use a system, not to the software as a product. The four findings that come up…
10 min read
Clinical OperationsPharma
CRO Oversight Under RBM: What the Sponsor Cannot Delegate
Monitoring can be delegated; oversight cannot. What a sponsor keeps under RBM, what inspectors ask for, and…
8 min read
Clinical OperationsPharma
The Data Behind Risk-Based Monitoring: EDC, CTMS and Site Metrics
Most RBM programs stall on data, not method. What EDC, CTMS, ePRO and lab feeds have to join up before a risk…
9 min read
Clinical OperationsPharma
Monitoring Plans: Splitting Central, Remote and On-Site Work
Not every check needs a site visit, and not every check survives going remote. How to split a monitoring plan…
9 min read
Clinical OperationsPharma
Reduced SDV: What Changes When You Stop Verifying Every Field
Cutting SDV saves monitoring days and moves risk somewhere else. Which data points still need verification…
9 min read