Importance of Quality Assurance in Clinical Trials

Since 30 years, Navitas Life Sciences has committed to transforming healthcare by supporting efficient and high-quality clinical Trials. Even today, we conduct our clinical trials with the same pride and feeling of satisfaction. Quality is at the core of our efforts, and we adapt effectively to changing needs and conditions.

We met with Anand. C. Rao, Vice President Quality Assurance at Navitas Life Sciences to get more insights about quality practices at Navitas Life Sciences and learn how to embark on a journey towards optimum quality. Anand recently received the “Top Most Quality Leader Award” 2022 from World Quality Congress and Awards in recognition of his sustained commitment to ensuring quality at every stage in our organization.

Tell us about your professional background?

I'm a Total Quality Management (TQM) professional by education with MBA in TQM, Master's in Biochemistry, and Laboratory Medicine. I have 21 years of rich experience in working with GxP-regulated industries. I have worked with small, medium to big organizations in the field of Healthcare, Pharmaceutical, Clinical Research, Life Sciences, and Medical Devices.

I have designed and implemented risk-based approach to Quality Management System in order to comply with the requirements of GLP, GCP, GPVP and GMP etc. I worked with US-FDA to implement their in-house technological solutions. I have supported many organizations to reap the benefits of Quality Management systems and operational excellence by promoting a quality culture. Conducted more than 500 quality audits and successfully hosted 10+ regulatory inspections. I'm part of ISPE-GAMP India steering committee, sharing my knowledge and expertise with Biopharmaceutical Industry.

Anand. C. Rao

Vice President Quality Assurance,

Navitas Life Sciences

What is the essence of quality management?

Implementing a suitable Quality Management System is critical for the growth and sustainability of the Organizations. One size won't fit into all. QMS requirements will vary from Organisation to Organisation based on customer needs, expectations and products and/or services they offer.

Building sustainable quality culture is essential to producing high-quality products and services by eliminating defects and incorporating changes and continuous improvements in the quality management system. High-quality products and services, in turn, lead to loyal and satisfied customers who bring repeated business and new customers along with them.

How do you ensure Quality in the organization?

At Navitas, quality assurance is an independent organization that directly reports to the executive management. Our management is fully committed to Quality. The quality team is empowered to identify and implement quality management system requirements. We have defined and implemented the industry's best practices, principles, and framework of the quality management system that infuses Quality into every aspect of our operations. Our resources are fully trained on QMS processes and systems to perform their day-to-day operations. The quality Assurance team closely works with operational teams. We guide and support them to deliver Quality that meets the needs and expectations of our customers. The quality team performs independent assessments and regular audits to ensure that the process and systems implemented are suitable and relevant to the current business needs.

For us, Quality is a long-term concept; we have taken and implemented concepts and methodologies from "Total Quality Management" to balance quality and compliance requirements. Quality performance indicators help us measure the efficiency and effectiveness of quality operations and make evidence-based decisions for the required improvements. Our ultimate goal is to deliver practical, high-quality products and services to our customers quickly and consistently. For that, we always keep striving for the improvement of Quality.

Do we have any certification/standards for quality management?

Yes, we are certified for ISO 9001:2015 Quality Management Standard and ISO 27001:2013 Information Security Management Systems.

What are you and your team most proud of having accomplished during the pandemic?

Pandemic has posed a lot of challenges to quality organizations across the globe. We are one of the few Organizations to implement suitable QMS changes in quick succession and deliver our products and services to customers without impacting the quality and performance end. As an Organisation, we anticipated the risks associated with the pandemic and remote working, identified suitable solutions, and implemented them to avoid any compromises in delivering Quality.

What are some of the articles that you have written on quality management to spread awareness?

I'm enthusiastic about sharing my knowledge and expertise with industry colleagues that may help them to implement effective QMS. As a speaker, I have participated in many national and international conferences, seminars, and webinars and shared the stage with renowned quality professionals from different parts of the world.

I have written many articles on LinkedIn, with many users benefitting from it. I have even written an article on the quality management system requirements for the CRO industry based on the ICH-E6R2 risk-based approach to quality management. This article got published in ET health with the title: The future of clinical trial conduct demands a quality system approach. Are you ready?

You recently won an award, can you tell us more about it?

Winning an award is always a special moment, I'm honored and humbled to receive "Top Most Quality Leader Award" 2022 from World Quality Congress and Awards, endorsed by World Manufacturing Congress & AwardsTM, The Business Leader of the YearTM & Stars of the IndustryTM & Strategic Partner World Leadership Congress & AwardsTM. My heartfelt thanks and gratitude to all my friends, family, colleagues and management at Navitas for their support.

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IDMP