Audit & Traning

1. Understanding Regulatory Compliance

Pharmaceutical companies must adhere to various global regulatory standards to ensure product safety, efficacy, and quality. Our team provides expert guidance on compliance with:

• GMP (Good Manufacturing Practices)
• GCP (Good Clinical Practices)
• GLP (Good Laboratory Practices)
• USFDA 21 CFR Part 11
• EU Annex 11
• ISO & ICH Guidelines

Our approach helps companies align their processes with these regulations to prevent compliance risks and ensure audit readiness.

2. Gap Assessment & Pre-Audit Preparation

Before regulatory inspections, a Gap Assessment is conducted to identify potential compliance risks. This step includes:
Reviewing existing quality management systems (QMS)
Evaluating documentation and procedural compliance
Identifying regulatory weaknesses and non-conformities
Developing a corrective action plan for compliance improvement

Our Pre-Audit Preparation ensures that your organization is fully prepared for regulatory inspections, reducing the risk of penalties and non-compliance issues.

3. Comprehensive Audit Services

We conduct detailed audits across various regulatory areas to ensure compliance and operational efficiency.

GMP Audits

• GMP Audits for APIs and Starting Materials
• Vendor and Excipients Audits
• Packaging Material Audits
• Third-Party Manufacturing Support
• Bioequivalence Studies Monitoring and CRO Audits

GCP Audits

• Investigator Site Audits
• Clinical Lab Audits
• IRB Audits (Indian Ethics Committees)
• Due Diligence Audits
• Electronic Data Capture (EDC) System Audits
• Clinical Trial Material Audits

GLP Audits

• Animal Facilities & Pathology Lab Audits
• Sponsor and CRO Audits
• Pharmacokinetics and Toxicology Audits
• Pre-approval Inspection Audits
• Mock FDA Audits

Computer Systems Validation (CSV) Audits

• IT System Security and Access Control Audits
• Vendor and Supplier Qualification Audits
• 21 CFR Part 11 & Data Integrity Compliance Audits
• SAP Implementation & System Validation Audits
• Risk-Based Remediation Plans.

4. Training Programs for Compliance Excellence

To ensure continuous compliance, we provide structured training programs for technical teams, quality assurance professionals, and regulatory personnel. Our training modules cover:
GMP, GCP, and GLP Compliance Training – Best practices for pharmaceutical manufacturing and research
Data Integrity & 21 CFR Part 11 Compliance – Ensuring electronic record-keeping meets global standards
Regulatory Inspection Readiness – How to prepare for FDA, EMA, and other regulatory inspections
Audit & Risk Management – Identifying, assessing, and mitigating compliance risks
Computer System Validation (CSV) Training – Implementing GAMP, data security, and software validation

Our training sessions are designed to equip teams with practical knowledge, enabling them to maintain compliance and improve operational efficiency.

5. Post-Audit Support & Continuous Compliance Improvement

Compliance is an ongoing process. After conducting audits and training, we provide:
Corrective and Preventive Action (CAPA) Plans
Root Cause Analysis for compliance issues
Implementation of best practices for continuous improvement
Long-term compliance monitoring strategies

By integrating audit, training, and compliance strategies, we help pharmaceutical companies strengthen their quality systems and regulatory readiness.

Empowering Your Compliance Journey

We empower pharmaceutical, biotechnology, and medical device companies with comprehensive GxP consultancy services. Our tailored compliance solutions and meticulous audits help organizations enhance operational efficiency, build industry credibility, and secure global market access.

For regulatory excellence and compliance assurance, partner with VMT Softsol. Let’s build a future of quality, efficiency, and regulatory confidence togethe