170+ computerized systems validated for pharma, biotech and medical device teams, from PharmaSuite MES and TraceLink to Waters Empower, Veeva Vault and generative AI tools. Risk-based, Part 11-compliant and inspection-ready.
Validation experience
170+ GxP systems validated across pharma, biotech and medical devices
Our validation engineers have delivered risk-based computer system validation (CSV) and Computer Software Assurance (CSA) for shop-floor MES and PLCs, serialization, chromatography data systems, eQMS, clinical platforms, cloud SaaS and generative AI tools. Each engagement is scaled to the system’s intended use and GxP risk under 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (Second Edition) and the FDA’s final CSA guidance.
170+systems validated
12system categories
CSV + CSArisk-based methodology
Part 11& Annex 11 aligned
Featured platforms
What validation covered on our most-requested systems
Rockwell FactoryTalk PharmaSuite MES
Path-based test design from master-recipe workflows, equipment logic (EQ status, clean & check), electronic batch records and Part 11 e-signatures.
TraceLink & Loftware NiceLabel
Serialization and labeling for new product introductions: product master data, label templates, aggregation and change-controlled release.
TrackWise Digital
Salesforce-based eQMS: workflow and automation changes (Process Builder → Flow) re-verified without re-validating the whole system.
Waters Empower
Chromatography data system validation focused on audit trails, user roles, result integrity and ALCOA+ data review.
Veeva Vault
QualityDocs, RIM, Clinical, eTMF, Safety and PromoMats: we use vendor release evidence and risk-assess each release rather than re-testing it.
Salesforce & SAP
Enterprise platforms validated end to end: configuration, integrations, data migration and reconciliation evidence.
Full list
Browse systems by category
Search for your system, or jump to a category. If your system isn’t listed, we have almost certainly validated one like it.
Manufacturing Execution & AutomationSerialization & LabelingEnvironmental Monitoring & FacilitiesQuality, Documents & RegulatoryClinicalMedical Device & Digital HealthLab, R&D & ScientificSoftware Testing & DevOpsEnterprise, ERP & FinanceCloud, Infrastructure & SecurityAI & GenAI ToolsCommercial, Marketing & Collaboration
No match. Ask us about your system →
Manufacturing Execution & Automation 24
MES, PLC, machine vision, robotics and production equipment software.
Computer System Validation →Serialization & Labeling 5
Track-and-trace, DSCSA serialization and GxP label management.
Computer System Validation →Environmental Monitoring & Facilities 5
Continuous monitoring, alarms and facility control systems.
Data Integrity services →Quality, Documents & Regulatory 16
eQMS, document control, regulatory submissions and safety systems.
Part 11 / CSA Readiness →Medical Device & Digital Health 5
Device software, diagnostic platforms and connected-device clouds.
CSA consulting →Lab, R&D & Scientific 24
Chromatography data systems, ELNs, imaging and statistical software.
Data Integrity services →Software Testing & DevOps 20
Test automation, ALM and the toolchain behind validated software.
ALM Implementation →Enterprise, ERP & Finance 21
ERP, CRM, finance, logistics and analytics platforms.
System Integration Testing →Cloud, Infrastructure & Security 20
IaaS, identity, endpoint, monitoring and security tooling.
Cloud Assurance →AI & GenAI Tools 7
Generative AI and machine-learning tools assessed for GxP use.
AI/ML & GenAI Validation →Commercial, Marketing & Collaboration 20
SaaS tools given right-sized, risk-based assurance.
CSV → CSA Transition →What you get
Inspection-ready deliverables for every system
- Validation Plan and system risk assessment
- URS / FRS and configuration specifications
- IQ / OQ / PQ protocols or CSA scripted and unscripted testing
- Requirements traceability matrix
- Part 11 / Annex 11 and data integrity (ALCOA+) assessment
- Supplier assessment and use of vendor evidence
- Validation Summary Report
- Change control, periodic review and decommissioning
Confidentiality. This is a representative list of platforms our team has validated. Client names, configurations and validation records stay confidential.
FAQ
Common questions about software validation
Can you validate a system that isn’t on this list?
Yes. The list shows platforms we have already delivered, but our risk-based method applies to any GxP computerized system, whether it is COTS, configured, custom or SaaS.
Do you follow CSV or CSA?
Both. We apply the FDA’s Computer Software Assurance approach where it fits and traditional CSV where your SOPs or regulators expect it, and we can move your program from CSV to CSA.
How do you validate SaaS and cloud platforms that release several times a year?
We qualify the vendor, use their release evidence, risk-assess each release and test only what changes your intended use. See Cloud Assurance.
Can AI tools such as ChatGPT or Claude be used in GxP work?
Yes, with a defined intended use, risk controls and human review. We have assessed several generative AI tools. See AI/ML & GenAI System Validation.
Validating one of these systems, or something new?
Tell us the system and its intended use. We’ll come back with a risk-based, fixed-scope validation approach.
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