Pharmaceuticals Compliance Automation
Accelerate validation, ensure audit readiness, and streamline compliance—Validator delivers automated solutions built for the demands of modern pharmaceutical manufacturing.
Automated Validation for Modern Pharmaceutical Compliance
Pharmaceutical companies face some of the world’s toughest regulatory expectations. From clinical trials to commercial manufacturing, compliance is not just a safety requirement—it’s essential for business continuity and reputation. But traditional validation approaches are slow, paper-heavy, and prone to error, especially as product portfolios grow and regulations shift.
Validator delivers what pharmaceutical teams actually need: end-to-end automation for all core validation activities—computer systems, process, equipment, and cleaning. Our platform is designed by practitioners who know the realities of supporting multi-site plants, global supply chains, and complex product lines. With Validator, you gain control, reduce manual burden, and spend less time preparing for audits—and more time delivering safe, high-quality medicines.
A Platform Designed for Pharmaceutical Needs
Validator was built to answer the real compliance challenges of modern pharma:
- Integrated Computer System Validation: Automate protocol creation, approvals, risk-based testing, traceability, and ongoing monitoring—aligned to GAMP 5, FDA, and global guidelines.
- Process Validation Support: Manage all three stages (design, qualification, ongoing verification) in a unified workflow. Track batches, trend data, and respond rapidly to deviations or process changes.
- Equipment Qualification: From installation to annual requalification, every step is automated, instantly documented, and easy to retrieve. Impact assessments and change controls ensure validated state throughout.
- Cleaning Validation: Standardize procedures, automate scheduling and records, and keep every area audit-ready.
- Seamless Integration: Validator connects with your LIMS, MES, ERP, and other core systems—no more duplicate entry or missing data.
Technical Strengths Compliance Teams Rely On
- Built-in GAMP 5 V-Model alignment, CSA-first workflows, and 21 CFR Part 11/Annex 11 support
- Audit trail, e-signature, and data integrity controls for U.S., EU, and global requirements
- Role-based access and impact assessments for system upgrades
- Change control workflows integrated with validation documentation
Business Impact You Can Trust
- Faster Validation: Speed up cycle times by 40% or more—get products to market and inspections closed with less stress and fewer late nights.
- Audit Confidence: Real-time dashboards, automated documentation, and instant traceability means you’re always prepared for FDA, EMA, and internal audits.
- Team Empowerment: Free your staff from repetitive manual work, reduce risk of error, and build a proactive, resilient compliance culture.
- Every Project a Success:
Each Validator implementation is a proven win—clients go live on schedule, achieve their compliance goals, and are ready to serve as references for our results.
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
How does Validator support FDA and global pharmaceutical compliance requirements?
Validator is designed to meet FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 standards. It provides electronic signatures, audit trails, robust documentation, and real-time traceability to keep your operations compliant and audit-ready in any regulatory environment.
Can Validator handle both small-batch and large-scale pharmaceutical manufacturing?
Absolutely. Validator is scalable to support single-site startups or global enterprises, automating validation processes for any product volume or manufacturing complexity.
How quickly can pharmaceutical teams implement Validator?
Implementation is typically completed in 2–4 months. Our experts manage configuration, integration, and team training to ensure a smooth, rapid transition to automated compliance.
Does Validator streamline both product launch and ongoing compliance activities?
Yes. Validator automates validation for new product introductions and supports ongoing process, equipment, and cleaning validations—helping your team reduce workload and remain compliant across every stage of the product lifecycle.
Testimonials
Here are a few of our client and their testimonials
