Biotechnology Compliance Automation
Accelerate innovation and stay audit-ready—Validator automates validation and compliance processes for fast-moving biotechnology teams in a rapidly evolving regulatory landscape.
Compliance That Moves With Your Products
Medical device manufacturers must meet demanding regulations from FDA, EU (MDR/IVDR), and global authorities, while maintaining full product traceability and design history. Each new product, process, or market requires careful validation and documentation through all lifecycle stages—that’s a tall order with paper-based systems or inflexible generic software.
Validator gives medical device companies a faster, smarter path to compliance. Designed by practitioners with deep device experience, Validator automates every step of the validation, qualification, and QMS documentation workflow. No more chasing records, struggling with version control, or dreading audit questions—just streamlined, audit-ready operations from design to post-market.
A Validation Platform Built for Biotech Growth
Validator fits the unique needs of dynamic biotech teams:
- Computer System Validation Made Simple: Automate creation of requirements, protocols, risk assessments, and approvals. Validator’s workflows are flexible—supporting fast-moving, ever-changing environments.
- Powerful Process Validation: Manage initial process design, qualification, and ongoing verification all in one platform. Automated trending and real-time batch reporting keep you ahead of process variability and regulatory expectations.
- Equipment & Cleaning Qualification: Remove bottlenecks—Validator tracks installation, operation, performance, and cleaning validations for every asset and area, ensuring no steps are missed, and every change is documented.
- Integrate, Don’t Overhaul:
Validator connects with LIMS, ERP, and lab automation platforms already in use. You keep what works, Validator makes it all easier.
Compliance and Technical Excellence—Without Slowdowns
- Aligned with GAMP 5, CSA, 21 CFR Part 11, and EU Annex 11 out of the box.
- Complete audit trail, dual-component e-signatures, secure data, and role-based access.
- Risk-based testing and automated traceability that satisfy both global regulators and internal stakeholders.
Accelerate Science, Not Just Paperwork
- Speed: Shorten validation timelines and get new therapies moving—confident in your compliance and documentation.
- Scalability: Grow with ease. From start-up biotechs to platform companies, Validator adapts as your pipelines, teams, and volume increase.
- Confidence: “Ask any current client—every Validator implementation is 100% successful.”
- People First:
Teams spend less time on compliance admin, more on groundbreaking science and scaling the next big innovation.
Tailored Automation For Every Validation
Validator is designed to tackle your biggest compliance pain points either one process at a time or across your entire validation lifecycle.
Explore each core solution to see how Validator can streamline your work and strengthen your audit confidence.
Computer System Validation (CSV)
Validator automates every phase of system validation, from protocol creation to risk management and compliance documentation. Records and traceability are built in and reliable, keeping your systems audit-ready at all times.
Process Validation (PV)
Experience more control and fewer surprises with automatic protocols, batch records, and trend data integration. All three stages of process validation—design, qualification, ongoing review—move faster and smarter with Validator.
Equipment Qualification (EQ)
Keep every asset documented and up to date. From installation through annual verification, Validator manages every protocol, document, and calibration so you’re always ready for inspection.
Cleaning Validation
Cleaning schedules, procedures, and proof are managed for you. Auditors get instant access to every record, while your team has more time for high-value work.
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
Can Validator support validation for gene therapies, cell therapies, and emerging biotech products?
Yes. Validator is designed to automate validation and compliance processes for all biotechnology products—including gene and cell therapies, biologics, vaccines, and more—while adapting to evolving regulatory expectations.
How does Validator help biotech teams keep pace with rapid growth and frequent process changes?
Validator’s flexible, configurable platform lets you adjust validation workflows quickly, automate documentation, and scale seamlessly as your pipeline or facilities expand—without sacrificing compliance or speed.
Does Validator integrate with biotech data management and laboratory systems?
Absolutely. Validator connects to LIMS, ERP, and laboratory automation systems, ensuring that validation records, trending, and data integrity are always maintained and easily accessible for audits.
How does Validator support biotech companies with lean teams and limited resources?
With Validator’s automation and expert-led support, even small teams can achieve comprehensive, audit-ready validation. This frees your staff to focus on science and growth, not endless documentation and compliance admin.
Testimonials
Here are a few of our client and their testimonials
