Clinical trial operations, compliance, and product notes from the TrialTrack team.https://trialtrack.net/https://trialtrack.net/blog/computer-system-validation-protocol-in-pharmaceutical-industry/https://trialtrack.net/blog/computer-system-validation-protocol-in-pharmaceutical-industry/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.Fri, 26 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/fda-guidance-on-computer-system-validation/https://trialtrack.net/blog/fda-guidance-on-computer-system-validation/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).Thu, 25 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/21-cfr-part-11-compliance-for-excel-spreadsheets/https://trialtrack.net/blog/21-cfr-part-11-compliance-for-excel-spreadsheets/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.Wed, 24 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/21-cfr-part-11-checklist/https://trialtrack.net/blog/21-cfr-part-11-checklist/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.Tue, 23 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/21-cfr-part-11-compliant-software/https://trialtrack.net/blog/21-cfr-part-11-compliant-software/“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.Mon, 22 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/ich-e6-r3/https://trialtrack.net/blog/ich-e6-r3/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.Fri, 19 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/clinical-data-management/https://trialtrack.net/blog/clinical-data-management/Clinical data management turns messy trial data into a clean, locked, defensible dataset — the lifecycle phase by phase, and the control proving each step.Thu, 18 Jun 2026 00:00:00 GMTData ManagementDejan Murkohttps://trialtrack.net/blog/clinical-project-management/https://trialtrack.net/blog/clinical-project-management/Clinical project management is its own discipline, not generic PM with a compliance bullet bolted on — why coordination, not the Gantt chart, is the real job.Wed, 17 Jun 2026 00:00:00 GMTOperationsDejan Murkohttps://trialtrack.net/blog/computer-system-validation/https://trialtrack.net/blog/computer-system-validation/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.Tue, 16 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/the-ich-gcp-guidelines/https://trialtrack.net/blog/the-ich-gcp-guidelines/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.Mon, 15 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/audit-trail-example/https://trialtrack.net/blog/audit-trail-example/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.Fri, 12 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/alcoa-principles/https://trialtrack.net/blog/alcoa-principles/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.Thu, 11 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/21-cfr-part-11/https://trialtrack.net/blog/21-cfr-part-11/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.Wed, 10 Jun 2026 00:00:00 GMTComplianceDejan Murkohttps://trialtrack.net/blog/clinical-trial-software/https://trialtrack.net/blog/clinical-trial-software/“Clinical trial software” isn’t one product — it’s a stack of layers (CTMS, EDC, eTMF, IRT) that each do a different job. A buyer’s map of the eClinical stack.Tue, 09 Jun 2026 00:00:00 GMTSoftwareDejan Murkohttps://trialtrack.net/blog/clinical-trial-management-system/https://trialtrack.net/blog/clinical-trial-management-system/A CTMS is the operational command center of a trial — but not every team needs one. What it does, who needs one, and how to choose without overbuying.Mon, 08 Jun 2026 00:00:00 GMTSoftwareDejan Murko