Vmt soft sol

Audit & Training

We're your trusted partner in achieving top-tier quality and ensuring seamless regulatory compliance for your organization. At VMT Softsol, we provide high-class consultancy services tailored to your needs, helping businesses master compliance and succeed in regulatory inspections.

Our commitment

Navigating regulatory compliance can be challenging, but we simplify the process with our expertise and customer-focused approach. Our comprehensive services enhance compliance standards and operational efficiency, ensuring long-term success.

Empowering Your Compliance Journey
We support pharmaceutical, biotechnology, and medical device companies with a full suite of GxP consultancy services. From in-depth audits to customized compliance strategies, our goal is to optimize operations, strengthen reputations, and secure global market access.

Our Key Services:

  • GMP Audits for APIs and Starting Materials
  • Vendor and Excipients Audits
  • Packaging Material Audits
  • Third-Party Manufacturing Support
  • Bioequivalence Studies Monitoring and CRO Audits
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Let us go forward in this battle fortified by conviction that those who labour in the service of a great and good cause will never fail.

Auditing

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:
βœ” Reviewing existing quality management systems (QMS)
βœ” Evaluating documentation and procedural compliance
βœ” Identifying regulatory weaknesses and non-conformities
βœ” 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:
πŸ“Œ GMP, GCP, and GLP Compliance Training – Best practices for pharmaceutical manufacturing and research
πŸ“Œ Data Integrity & 21 CFR Part 11 Compliance – Ensuring electronic record-keeping meets global standards
πŸ“Œ Regulatory Inspection Readiness – How to prepare for FDA, EMA, and other regulatory inspections
πŸ“Œ Audit & Risk Management – Identifying, assessing, and mitigating compliance risks
πŸ“Œ 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:
βœ… Corrective and Preventive Action (CAPA) Plans
βœ… Root Cause Analysis for compliance issues
βœ… Implementation of best practices for continuous improvement
βœ… 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 together.

Let us go forward in this battle fortified by conviction that those who labour in the service of a great and good cause will never fail.

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