Process Validation Automation
Automate every phase with a platform built for real-world compliance and fast-paced product cycles.
Make Process Validation Automatic
Automate protocols for any process—manufacturing, lab, or clinical
Track batch records, trending data, and process changes in one place
Generate validation master plans, reports, and summaries instantly
Eliminate redundant manual reviews and error-prone data silos
Ensure consistent execution, even during tech transfers or scaling
Bring Every Step of Your Process Into Sync
Still using manual process validation and vendor provided protocols? Relying on scattered systems makes process validation hard to manage and nearly impossible to scale.
Validator brings everything together. By connecting with your systems, it continuously monitors your processes, flags issues early, and keeps your records audit-ready. So whether you’re prepping for a product launch, a tech transfer, or your next regulatory review, you’re already a step ahead.
Precision At Every Stage Of The Process
- Automates Stage 1 (Design), Stage 2 (Qualification), and Stage 3 (Continued Process Verification)
- Built-in data integration for ERP, LIMS, and batch records—real-time trending included
- Customizable workflows for every product, team, or process
- Lifecycle continuity with change control, deviation tracking, and CAPA built in
- All changes are documented and approved without disruption
By The Numbers
Teams using Validator for PV have:
- Cut review cycles by 40% or more
- Eliminated trending errors and data silos before they escalate
- Kept batch documentation always audit-ready
- Improved product quality without increasing headcount
How Validator Works At Every Stage
Planning & Risk Assessment
Validator starts by designing a robust process validation master plan, defining CQAs and CPPs, and mapping risk according to GAMP 5 and regulatory expectations.
Design & Qualification
Validator systematically captures process and design parameters, automates mapping and traceability, and aggregates supplier/vendor input as needed.
Testing & Execution
Validator automates generation and management of qualification protocols, trending analysis, process/batch review, and deviation/doc control.
Continued Verification & Reporting
Track and trend process performance in real time batch-by-batch, year-over-year. Generate validation summary reports automatically and manage annual/ongoing review cycles with less manual effort.
Meet Every Global Standard
- 21 CFR Part 11 & EU Annex 11: Digital records, e-signatures, audit trails, trending, and risk-based compliance
- GAMP 5: Life-cycle methodology, risk/category-aligned, and integrated change control and process monitoring
- Continuous improvement and CAPA built into each stage
Backed By Numbers
40%
Time saved on validation projects
300+
Successful client implementations
100%
Audit-ready documentation success
20k
Active users in regulated industries
Industries We Support
Any pharmaceutical, biotechnology, or medical device company that needs lifecycle transparency, robust trending, and efficient verification—from development through commercial manufacturing.
Compliance That’s Proactive, Integrated, And Ready For What’s Next
Not all platforms are created equal. Validator is shaped by experience—built and implemented by people who have worked inside life sciences teams, led audits, and solved real regulatory problems.
Constant Compliance
Real-time dashboards create a living audit trail, so your team works from current data and your compliance stays inspection-ready.
Integrated With Your Systems
Every connection is fully configurable to your LIMS, ERP, MES, HR, finance, and risk systems with no custom code, so you can access and personalize without calling IT.
Fast ROI with Proven Efficiency
Achieve over 40% efficiency gains and 100% implementation success. Fast ROI with Validator fully configured and running smoothly within 3 months.
Always Up-to-date
As regulatory standards evolve, so does Validator, to ensure your validation system follows CSA and globally aligned practices for international compliance.
Frequently Asked Questions
What is process validation, and why is it required in life sciences?
Process validation ensures that manufacturing processes consistently produce products meeting predefined quality criteria. Regulatory agencies like the FDA require it to safeguard product quality, patient safety, and compliance.
How does Validator automate process validation workflows?
Validator manages all stages—design, qualification, and ongoing verification—by automating protocol generation, data trending, approvals, and documentation. This reduces manual work, speeds up reviews, and makes reporting easier.
Can Validator trend and analyze batch/process data in real time?
Yes. Validator integrates with your ERP, LIMS, and production systems to collect, trend, and visualize critical process and batch data for ongoing verification and faster decision-making.
Is Validator compliant with relevant regulatory guidelines for process validation?
Absolutely. Validator’s workflows align with FDA and EMA process validation guidelines, GAMP 5 best practices, and data integrity requirements, ensuring every report and record meets inspection standards.
How does Validator handle process changes or deviations?
Validator includes built-in change control and deviation management. Every change is tracked, assessed for risk, and reflected in process documentation—keeping you compliant and always ready for audit.
Testimonials
Here are a few of our client and their testimonials
