Frequently Asked Questions

CSV is a documented process used to ensure that computerized systems—such as LIMS, MES, and ERP—perform as intended and meet regulatory requirements. Validating these systems is essential to protect data integrity, ensure product quality, and pass audits from agencies like the FDA and EMA.

Validator automates every stage of the CSV process—from planning and risk assessment to protocol generation, execution, approvals, and reporting. It eliminates manual data entry, automates traceability, and keeps documentation audit-ready at all times.

Absolutely. Validator is fully configurable to your procedures, risk models, and approval chains—no custom development needed.

Validator includes built-in change control and impact assessment workflows, so every modification or upgrade is tracked, assessed for risk, and validated to maintain compliance over the system’s lifecycle.

Yes. Validator is designed for seamless integration with LIMS, MES, ERP, and other enterprise platforms, ensuring data flows smoothly and validation records stay complete.

Many organizations are fully implemented in as little as 2–4 months. Our team handles configuration and onboarding to get your team compliant and confident quickly.

Validator is implemented and supported by the experts who built it—not third-party consultants—so you get consistent, expert guidance from day one through every future regulatory change.

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.

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.

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.

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.

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.

Equipment qualification verifies that lab and manufacturing equipment operates correctly and consistently, meeting all regulatory requirements. It’s essential for ensuring product quality, data integrity, and audit readiness.

Validator streamlines each step—installation (IQ), operational (OQ), and performance qualification (PQ)—by generating, routing, and securely storing all required protocols and records with built-in approvals and alerts.

Yes. Validator’s built-in change control workflow manages impact assessments and requalification, ensuring all modifications are tracked and validated throughout the equipment lifecycle.

Absolutely. Validator supports FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards, providing complete audit trails, electronic signatures, and documentation integrity.

Validator provides real-time dashboards, alerts for overdue tasks, and instant access to all qualification and calibration records—so your team is always inspection-ready, with no surprises.

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.

Absolutely. Validator is scalable to support single-site startups or global enterprises, automating validation processes for any product volume or manufacturing complexity.

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.

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.

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.

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.

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.

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.

Yes. Validator is fully configurable for a wide range of devices and manufacturing processes, and supports regulatory requirements for FDA, EU MDR/IVDR, ISO 13485, and other global standards.

Validator centralizes DHF documentation, automatically tracks changes, and provides a complete audit trail—making it easy to demonstrate compliance and manage updates throughout the device lifecycle.

Absolutely. Validator covers IQ, OQ, PQ, cleaning validation, and process validation from initial setup to requalification—ensuring all records, approvals, and schedules are managed in one platform.

Validator maintains real-time, audit-ready records, instant document retrieval, and full traceability for every device, process, and protocol—so you’re always prepared for inspections, with confidence.

Yes. Validator supports GMP and FDA 21 CFR Part 111 standards for nutraceuticals and supplements, ensuring audit-ready records, electronic signatures, and secure, traceable documentation for all required processes.

Validator automates change control and impact assessment workflows, making it easy to document, review, and validate any adjustments to formulations, suppliers, or production methods—keeping compliance up to date as your offerings evolve.

Absolutely. Validator is built to integrate seamlessly with ERP, LIMS, and inventory or quality management systems, so your data flows directly and your compliance documentation is always aligned with business operations.

Validator reduces the documentation burden and manual validation workload, allowing smaller teams to achieve and maintain compliance efficiently—minimizing errors, audit risk, and time spent on paperwork.

Validator scales easily for startups, mid-size businesses, and global organizations alike. Its modular design and expert-led onboarding mean any team can benefit from automation and audit-ready compliance.

Absolutely. Validator is built to connect seamlessly with your ERP, LIMS, MES, and quality management systems, streamlining data flow and documentation across all your operations.

Validator maintains a full, real-time audit trail and centralized documentation. You get instant access to records, e-signatures, and approvals—making every audit or inspection routine, not stressful.

Most clients are fully implemented in 2–4 months. Our team handles configuration and training, so you realize the benefits of automation fast.

The best way is to schedule an intro call or request a personalized demo. Our experts will walk you through Validator’s capabilities, answer your unique questions, and map a plan that fits your needs.

Equipment qualification verifies that lab and manufacturing equipment operate correctly and consistently, meeting all regulatory requirements. It’s essential for ensuring product quality, data integrity, and audit readiness.

Validator streamlines each step—installation (IQ), operational (OQ), and performance qualification (PQ)—by generating, routing, and securely storing all required protocols and records with built-in approvals and alerts.

Yes. Validator’s built-in change control workflow manages impact assessments and requalification, ensuring all modifications are tracked and validated throughout the equipment lifecycle.

Absolutely. Validator supports FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards, providing complete audit trails, electronic signatures, and documentation integrity.

Validator provides real-time dashboards, alerts for overdue tasks, and instant access to all qualification and calibration records—so your team is always inspection-ready, with no surprises.

Yes. Validator is flexible and configurable to support diverse life sciences environments, including contract research organizations (CROs), diagnostics labs, and specialty pharma manufacturers—ensuring tailored compliance and validation across different workflows.

Validator centralizes all validation documents, records, and audit trails in one secure platform—making it easy to access, organize, and retrieve records for audits, no matter how distributed your teams or facilities.

Absolutely. Validator supports smooth archiving, legacy system decommissioning, and conversion to digital records, helping organizations modernize and maintain data integrity during transitions.

Life sciences teams using Validator typically experience significant reductions in manual workload and documentation errors, improved audit outcomes, and faster, more reliable compliance processes—freeing staff to focus on research and innovation.

Validator is designed to meet FDA and EU requirements for electronic records and signatures. It provides comprehensive audit trails, secure access controls, e-signatures, and automated record retention for seamless regulatory compliance.

Yes. Validator is scalable for organizations with multiple sites, international facilities, and distributed teams—ensuring consistent validation, documentation, and compliance oversight everywhere you operate.

Validator keeps all validation documents, approvals, and audit trails organized and instantly accessible. With real-time dashboards and search, your team is always prepared for scheduled or unannounced inspections.

Validator automates computer system validation (CSV), process validation (PV), equipment and cleaning qualification, change control, and integrates with LIMS, ERP, and QMS—covering all documentation required for regulatory submissions and ongoing audits.