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Vishal Mhatre

Increasing globalization has enabled pharmaceutical giants to manufacture extensively across geographies. This has influenced procurement of medicines and other consumables required in the healthcare industry. More contract manufacturing alternatives for better and cost-effective products will lead to compliance issues and auditing challenges for quality assurance.

The current globalization scenario highlights the need for virtual audits of manufacturing sites. Virtual audits will help in product registration and continuous supply of medicines under competitive international biding and will serve as the new normal considering the current pandemic situation.

Automating the virtual audit

Virtual audits require sharing of confidential or controlled documents and source data during the pre-audit and audit phase, which is an extensive process and about two to three times more time consuming than the onsite audit. The exchange of documents related to procedures, materials, methods, equipment, and IT or software, should be recorded, secure, and easily traceable. Sometimes, it also requires a local affiliate to coordinate with the health authority to ensure the availability of documents in line with the local requirements.

Designing the virtual environment for audits

Securing the associated intellectual property rights and confidentiality creates an environment that provides access to all the parties involved. According to the pharmaceutical company’s standards and the health authority requirements, a safe and secure site will enable ease of access and exchange of documents with the local affiliates and translation partners to prepare for an audit. The health authority stakeholders will also have access to the documents and folders related to the company’s product or manufacturing site, to check the compliance status of the supporting source data.

Leveraging the latest technology, access as per regulatory requirements, audit procedures, and the audit trail can be easily maintained and monitored. It can also be made available for further evaluation in conformity with the system validation requirements stated by the health authority.

Creating a secure virtual audit ecosystem

With the rise in virtual audits and related procedures in pharma industry, it is imperative to employ a cloud-based ecosystem with necessary security measures for conducting virtual audits. This will be used by both sponsor companies as well as multiple health authorities. It will reduce the load on internal IT teams of pharma companies and these virtual audits will be carried out at a third-party secure environment taking care of privacy and IP (intellectual property).

Even in the post-pandemic phase, the concept of remote auditing can be embraced using available, secure, and sustainable technology. Management of such collaboration sites with utmost security and flexibility using latest technologies such as cloud, blockchain, virtual tours using handheld devices, will help the pharmaceutical industry to ensure faster processing of necessary audits for site approvals in the long run and will eventually lead to the availability of medicines for patients in need, on priority.

The proposed viewpoint will be applicable for quality and regulatory-related audits, which enable site inspections specific to manufacturing, quality testing, stability testing, and warehouses. Virtual audit is one of the initiatives that can be adopted during a pandemic situation that will create a need for independent third-party sites to provide such services. 

The way forward

The fundamental principles related to virtual audit are security and privacy, the use of technology and emphasis on the significance of virtual audits. New technologies will help get more insights into data, allowing auditors to play an active role. However, it does require the necessary cloud-based solution in an industry that is booming rapidly. The virtual audit concept majorly requires buy-in from leadership, especially while sharing confidential and secure data with external stakeholders, and for prioritization of such initiatives.

About the author

Vishal Mhatre
Vishal Mhatre is an associate vice president and a domain consultant working with the Regulatory Services group within TCS' Life Sciences unit. Vishal brings in over 27 years of industry experience, and in-depth expertise in regulatory project management, product strategy development, regulatory operations, and compliance. He is currently leading the regulatory domain in TCS, and his expertise includes all aspects of business services and automation or IT transformation initiatives.
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