FAQ- Audit Services

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We offer a comprehensive suite of audit services for Pharmaceutical, Medical devices, Food, Cosmetics, Chemical industries and specialized audits tailored to specific industry or regulatory requirements.

• APIs,
• Excipients
• Packaging materials
• Medical devices
• Medicinal products
• subcontracted laboratory
• GDP, GCP, GLP,...
• Food safety
• For-cause-audits
• FDA-readiness audits
• GAP analysis audits
• GMP audits focus on specific areas
• Process/product audits
• Data integrity audits

Yes, we understand that each organization has unique needs and challenges. We'll work closely with you to customize the audit scope and approach to address your specific requirements.

Yes, we have extensive experience conducting audits Pharmaceutical, Medical devices, Food, Cosmetics, Chemical industries. Our team has worked with numerous organizations of Large and multinational companies.

Our audit methodology is based on industry best practices and internationally recognized standards (ex: ICH, USFDA, EMEA, PMDA, WHO, TGA, MHRA, etc,). We follow a structured checklist, risk-based approach that combines data analytics and process reviews to ensure a thorough and objective assessment.

Maintaining objectivity and independence is a top priority for us. We have robust quality control measures in place, including peer reviews, cross-checking, and secondary layers of review to ensure the accuracy and completeness of our audit findings.

We believe in open and transparent communication throughout the audit process. We provide regular updates, discuss preliminary findings, and collaborate with your team to ensure our recommendations are practical and actionable.

Our audit manager will assign a well-trained, experienced & qualified auditor based on the industry and scope of the audit. Auditor profile will be shared to the customer once the audit is planned.

The members of our audit team hold prestigious professional certifications, such as IRCA, ASQ, etc., and have an average of 15 years of experience conducting audits for organizations similar to yours. They bring a wealth of industry-specific knowledge and best practices to the engagement.

We place a strong emphasis on team continuity to ensure a seamless and efficient audit process. The core members of the audit team assigned to your engagement will remain consistent throughout the project, providing you with a cohesive and familiar point of contact.

The duration of an audit engagement can vary depending on the scope and complexity of the project, but our typical timeline for a comprehensive audit is 2 to 6 weeks from the initial planning phase to the final report delivery.

Absolutely, we'll work with you to develop a detailed project plan and timeline that outlines all the key milestones, deliverables, and responsibilities for your specific audit engagement. This will ensure transparency and alignment throughout the process.

In addition to the final audit report, which will be delivered at the end of the engagement, we'll provide you with regular updates, interim findings, and recommendations throughout the process as agreed upon during the planning phase.

Maintaining the confidentiality and security of our clients' data is of paramount importance to us. We have stringent data protection policies and procedures in place, including encryption, access controls, and secure data transfer protocols. Our team is also bound by strict confidentiality agreements to ensure the utmost protection of your sensitive information.

Yes, our IT infrastructure and systems undergo regular security audits and penetration testing to identify and address any vulnerabilities.

Upon the completion of the audit, we will securely destroy or return all client data and documents, in accordance with your preferences and our data retention policies. We do not retain or repurpose any of your sensitive information beyond the scope of the engagement. 

Our fee structure for audit services is based on the scope of work, the complexity of the engagement, and the level of expertise required. We provide transparent, fixed-fee proposals that outline all the associated costs upfront, so there are no surprises. 

We strive to provide a comprehensive and all-inclusive fee structure. The only additional costs that may arise are for any out-of-scope work or travel expenses, which we will discuss and obtain your approval for in advance." We will always quote reasonable price for the travel & accommodation.

Yes, we understand the importance of cash flow management for our clients. We are happy to discuss flexible payment terms, such as, progress-based billing (ex: milestone payments), to accommodate your preferred payment schedule.

Our clients consistently praise the expertise and professionalism of our audit team, as well as the transparency and timeliness of our communication throughout the engagement. They also highlight the practical and actionable nature of our recommendations, which have helped them drive meaningful improvements within their organizations.

We believe in a collaborative approach to auditing, where we work closely with your team throughout the engagement. We'll have regular check-in meetings, provide progress updates, and encourage open dialogue to ensure we're addressing your concerns and meeting your expectations.

 Yes, We offer a range of post-audit support services, such as implementation assistance, process improvement consulting, and periodic follow-up reviews to help you address the findings and recommendations from the audit.

You'll have direct access to the lead auditor and the engagement team throughout the audit process. We encourage you to reach out to us (info@livpqms.com) at any time, whether it's to discuss progress, clarify findings, or address any concerns that may arise. We're committed to providing responsive and personalized support to ensure a smooth and successful audit experience.