GxP systems we've validated
We have validated computerized systems for pharma, biotech and medical device teams, from PharmaSuite MES and TraceLink to Waters Empower, Veeva Vault and generative AI tools. Every project is risk-based, Part 11-compliant and inspection-ready.
- Rockwell FactoryTalk PharmaSuite MES
- TraceLink & Loftware NiceLabel
- TrackWise Digital
- Waters Empower
- Veeva Vault
- Salesforce & SAP
Manufacturing execution & automation 24
- Rockwell FactoryTalk PharmaSuite MES
- Siemens TIA Portal V17
- Siemens PLC Software
- Rockwell Studio 5000
- AVEVA Edge
- Cognex In-Sight Explorer
- Cognex In-Sight OPC Server
- Cognex DataMan
- Keyence
- Keyence SKH Data Acquisition
- Keyence VHX Remote Analysis
- Epson RC Plus
- Epson RC Plus Express
- Promess MotionPro
- Zaber Launcher
- LMS 300 Laser Cutting System
- Kardex Vertical Lift
- Simco Ion Manager Pro
- QC-CALC
- Instron Bluehill
- Smartscope
- Pyros eXpress
- Creality Print
- B9Create
Serialization & labeling 5
- TraceLink
- Loftware NiceLabel Cloud
- Brady Workstation Lab ID
- Zebra Printers
- QZ Tray
Environmental monitoring & facilities 5
- Vaisala viewLinc
- MadgeTech 4 Standard
- Novatek Environmental Monitoring
- Trident Water Leak Detection
- Lockview
Quality, documents & regulatory 16
- TrackWise Digital
- Veeva Vault QualityDocs
- Veeva Vault RIM
- Veeva Vault PromoMats
- Veeva Safety
- Veeva MedInquiry
- LifeSphere Medical Information
- FDA CDRH eCopy / eSubmitter
- Pinnacle 21 Enterprise
- Adaptive Compliance Engine (ACE)
- MedCompli
- Enhesa
- Sampling Plan Analyzer
- DocuSign
- Disclo
- Policy Reporter
Clinical 5
- Oracle CTMS
- Veeva Vault Clinical
- Veeva Vault eTMF
- ClinCard
- Precision Trial Analytics
Medical device & digital health 5
- KC Screener
- BioT Platform
- iTrace Aberrometer Software
- Tomey Data Transfer Software
- EndoScan-V
Lab, R&D & scientific 23
- Waters Empower
- Scilligence ELN
- Labguru
- Nikon NIS-Elements
- ChemDraw Pro
- ChemDraw Prime
- CAS SciFinder
- COMSOL
- MATLAB
- JMP
- Stata
- SAS Viya
- RStudio
- GraphPad Prism
- TreeAge Pro Healthcare
- Measurement Studio 2
- Analyst Diagnostic Tool
- Rayyan
- EndNote
- Article Galaxy
- PlotDigitizer
- AIKO SciLingual
- YarakuZen
Software testing & DevOps 20
- Tricentis Tosca
- Tricentis qTest
- Tricentis NeoLoad
- Tricentis Data Integrity
- OpKey
- Squish
- Microsoft Playwright
- Selenium
- Perforce ALM
- Bitbucket
- Docker
- Terraform
- VS Code
- Microsoft Visual Studio
- Windows Subsystem for Linux
- Miniforge
- Microsoft SBOM Tool
- GCOV
- MCU Bootloader
- Zadig
Enterprise, ERP & finance 22
- SAP
- Oracle Fusion
- Salesforce Platform
- Salesforce Field Service
- Salesforce Data Loader
- OwnBackup Secure
- FloQast
- AppZen
- FactSet
- Factura
- EGrant
- PlanPayer
- Pricee
- ShipJet
- FreightPop
- Oracle SQL Developer Data Modeler
- Google BigQuery
- Simba JDBC for BigQuery
- Tableau Cloud
- Komodo Health
- MedScout
- AlphaSense
Cloud, infrastructure & security 20
- Microsoft Azure
- Nutanix
- Wasabi Cloud Storage
- Okta
- Aquera
- 1Password
- Jamf
- Absolute
- Lansweeper
- Splunk
- PagerDuty
- AppOmni
- BitSight
- Abnormal AI
- Spirion
- Aruba ClearPass
- Mend
- IBM Aspera
- SecureCRT
- URI Ports
AI & GenAI tools 7
- Claude AI
- ChatGPT
- Google NotebookLM
- Adobe Acrobat AI
- Ultralytics
- Solve Intelligence
- NILES AI Coaching Tool
Commercial, marketing & collaboration 20
- Veeva CRM
- Braze
- LiveRamp
- Synthesia
- Vyond
- Canva
- Smartsheet
- Asana
- monday.com
- Miro
- Microsoft Planner
- Office Timeline Pro
- AlertMedia
- TigerConnect
- Pexip
- VooV
- Slido
- Kahoot
- QStream
- GoTrainingHub
FAQ
Can you validate a system that isn't on this list?
Yes. The list shows platforms we have already delivered. Our risk-based method applies to any GxP computerized system, whether COTS, configured, custom or SaaS.
Do you follow CSV or CSA?
Both. We use CSA where it fits and traditional CSV where your SOPs or regulators expect it. We can also help you move a program from CSV to CSA.
How do you validate SaaS and cloud platforms that release several times a year?
We qualify the vendor and use its release evidence. Then we risk-assess each release and test only what changes the system's intended use.
Can AI tools such as ChatGPT or Claude be used in GxP work?
Yes, if the intended use is defined and the work includes risk controls and human review. We have assessed several generative AI tools.
Validating one of these systems?
Tell us the system and your timeline. We have likely validated it before.