What are Periodic Review & Revalidation Services?

Our services include scheduled system reviews, trigger-based revalidation, change control integration, and decommissioning support, ensuring continued compliance throughout the system lifecycle.

Why is it Critical?

Periodic reviews and revalidations maintain system compliance, address deviations or upgrades, and ensure audit-readiness, minimizing regulatory risks.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led lifecycle solutions, providing robust, regulator-ready documentation to support compliance and operational continuity.

Our Expert Lifecycle Approach

At Indivirtus Healthcare Services, our Periodic Review & Revalidation services are led by certified validation experts with global regulatory expertise. We perform scheduled performance reviews, evaluate triggers for revalidation, integrate change control records, and manage system decommissioning with comprehensive documentation.

Our approach ensures audit-ready compliance, aligning with EU GMP Annex 15, US FDA Process Validation (Stage 3), WHO TRS 1019, ISPE Lifecycle Management Model, and ICH Q9 guidelines.

Periodic Review & Revalidation Deliverables

System Periodic Review Checklist: Structured assessment of system performance.

Trigger Event Evaluation Reports: Analysis of deviations or upgrades requiring revalidation.

Revalidation Strategy & Protocol: Tailored plan for system requalification.

Change Control Record Integration: Documentation aligning changes with validation status.

System Decommissioning Documentation: Records for retiring legacy systems.

Final Review Summary & Compliance Status: Comprehensive, audit-ready report.

Regulatory Compliance & Global Standards

Our Periodic Review & Revalidation services align with stringent global standards, ensuring your systems are audit-ready and compliant with international regulatory expectations. By adhering to industry-leading guidelines, we deliver solutions that enhance compliance and minimize risk.

  • EU GMP Annex 15 – Qualification & Validation: European standards for system validation.
  • US FDA Guidance on Process Validation (Stage 3): U.S. standards for continued process verification.
  • WHO Technical Report Series 1019: Global guidelines for validation and qualification.
  • ISPE Lifecycle Management Model: Framework for system lifecycle management.
  • ICH Q9 – Quality Risk Management: Guidelines for risk-based approaches in pharmaceuticals.

Applications & Use Cases

Our Periodic Review & Revalidation services are essential for pharmaceutical companies maintaining GxP compliance across system lifecycles. Ideal for manufacturing equipment, automated systems, and facilities, our solutions support global markets. Key use cases include conducting scheduled system reviews, revalidating after upgrades, and decommissioning legacy systems for FDA/EMA compliance.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led revalidation solutions backed by certified validation professionals with global experience. Our services ensure regulator-ready outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your organization with compliant, robust lifecycle management, driving regulatory success and operational continuity.

Frequently Asked Questions

Frequently Asked Questions

Why are periodic reviews important for validated systems?

Periodic reviews help ensure that validated systems continue to meet their intended purpose and regulatory expectations over time, reducing compliance risk.

What is a trigger-based revalidation?

Revalidation triggered by events such as system upgrades, deviations, audit findings, or changes in process that may impact product quality or data integrity.

Do you support system decommissioning documentation?

Yes, we provide full documentation for system decommissioning, including data migration plans and validation record archiving to support traceability.

How is change control linked with revalidation?

We review change control logs to identify potential impacts on validated state and determine whether revalidation is necessary as part of the change lifecycle.

What guidelines govern periodic review & revalidation?

Our approach is based on EU GMP Annex 15, FDA Process Validation Stage 3, WHO guidelines, ISPE best practices, and ICH Q9 risk management principles.

What do Periodic Review & Revalidation services include?

Our services include system review checklists, trigger event evaluations, revalidation protocols, change control integration, decommissioning documentation, and compliance summaries.

Who benefits from Periodic Review & Revalidation services?

Pharmaceutical companies maintaining GxP-compliant systems, equipment, or facilities benefit from our tailored lifecycle solutions.

How do these services ensure regulatory compliance?

Our services align with EU GMP Annex 15, US FDA Process Validation, WHO TRS 1019, ISPE Lifecycle Model, and ICH Q9, ensuring global compliance.

What deliverables are provided with the service?

Clients receive review checklists, trigger evaluations, revalidation protocols, change control records, decommissioning documentation, and compliance reports.

Can the revalidation services be customized for our needs?

Yes, our services are tailored to your specific systems, triggers, and regulatory requirements, ensuring compliant solutions.

How do the services support audit-readiness?

We provide comprehensive, regulator-compliant documentation and lifecycle management to ensure seamless audits and sustained compliance.