What are Compliance & Audit Support Services?
Our services provide PV system monitoring, compliance assessments, audit readiness preparation, CAPA planning, and training on GVP and ICH E2E, ensuring global pharmacovigilance compliance.
Pharmacovigilance Compliance & Audit Readiness
Stay Compliant with Expert PV Support
At Indivirtus Healthcare Services Pvt. Ltd., our Compliance & Audit Support service ensures your pharmacovigilance system meets global regulatory expectations. Through robust monitoring, inspection readiness, CAPA planning, and tailored training, we deliver audit-ready solutions aligned with GVP and ICH E2E guidelines.
Why is it Critical?
Continuous compliance and audit readiness ensure regulatory adherence, patient safety, and operational confidence, minimizing risks during health authority or internal audits.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led compliance solutions, strengthening your PV system for regulatory inspections and operational excellence.
Our Expert Compliance Approach
At Indivirtus Healthcare Services, our Compliance & Audit Support services are led by certified pharmacovigilance experts with global regulatory expertise. We conduct thorough compliance assessments, prepare audit readiness checklists, develop CAPA plans, and provide tailored training on GVP and ICH E2E guidelines.
Our structured approach ensures inspection-ready PV systems, integrating with your operations to align with EMA, FDA, and global standards, supporting both internal reviews and health authority audits.
Compliance & Audit Support Deliverables
PV Compliance Assessment Reports: Detailed evaluations of your PV system.
Audit Readiness Checklist: Comprehensive guide for inspection preparation.
CAPA Plans & Tracker: Action plans to address compliance gaps.
Training Session Reports: Documentation of GVP/ICH E2E training outcomes.
Mock Inspection Summaries: Simulated audit results to ensure readiness.
Regulatory Compliance & Global Standards
Our Compliance & Audit Support services align with stringent global pharmacovigilance standards, ensuring your PV system is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence.
- GVP Modules I-XVI: European standards for pharmacovigilance systems and processes.
- ICH E2E: Guidelines for pharmacovigilance planning and safety management.
- EMA/FDA PV Guidance: European and U.S. regulations for pharmacovigilance compliance.
- WHO Pharmacovigilance Guidelines: Global standards for safety monitoring.
Applications & Use Cases
Our Compliance & Audit Support services are essential for pharmaceutical companies and MAHs ensuring continuous PV compliance. Ideal for audit preparation, internal reviews, and CAPA implementation, our solutions support global pharmacovigilance requirements. Key use cases include preparing for EMA/FDA inspections, aligning PV systems with GVP, and training teams for compliance.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led compliance and audit solutions backed by certified pharmacovigilance professionals with global experience. Our services ensure scientifically defensible 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, and inspection-ready PV systems, driving regulatory success and patient safety.
Frequently Asked Questions
Frequently Asked Questions
What does PV compliance monitoring include?
It includes ongoing checks of your pharmacovigilance system to ensure it aligns with regulatory requirements, focusing on SOPs, case processing, risk management, and periodic safety update reports (PSURs).
How can I prepare for a pharmacovigilance inspection?
We support clients with mock inspections, gap assessments, document reviews, training, and strategic advice to ensure full preparedness for EMA, FDA, or local authority audits.
What’s included in CAPA management?
Our CAPA services include root cause analysis, CAPA plan drafting, implementation monitoring, effectiveness checks, and tracking systems to prevent recurrence of compliance issues.
Is GVP training mandatory for all staff?
Yes, staff involved in pharmacovigilance activities must be trained on GVP modules relevant to their roles. We provide role-based training covering modules I to XVI.
Can Indivirtus help with post-audit remediation?
Absolutely. We assist with CAPA execution, documentation corrections, retraining, and responding to inspection findings to ensure compliance restoration.
What do Compliance & Audit Support services include?
Our services include PV compliance assessments, audit readiness checklists, CAPA planning, GVP/ICH E2E training, and mock inspection summaries.
Who benefits from Compliance & Audit Support services?
Pharmaceutical companies and MAHs preparing for health authority audits or conducting internal PV reviews benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with GVP Modules I-XVI, ICH E2E, EMA/FDA PV Guidance, and WHO Pharmacovigilance Guidelines, ensuring global compliance.
What deliverables are provided with the service?
Clients receive compliance assessment reports, audit readiness checklists, CAPA plans, training session reports, and mock inspection summaries.
Can the compliance services be customized for our needs?
Yes, our services are tailored to your specific PV system, regulatory requirements, and audit goals, ensuring compliant and effective solutions.
How do the services support audit readiness?
We provide checklists, CAPA plans, mock inspections, and training to ensure your PV system is prepared for health authority or internal audits.