Panel Discussion: Pharma 4.0 – Digital and paperless laboratory: Need of the hour

The first panel discussion at Pharma LabNext Conclave 2021 was ‘Pharma 4:0 – Digital and paperless laboratory: Need of the hour.’ It examined how pharma laboratories will have to be at the cutting edge of science and technology to be more efficient, improve time-to-market and reduce costs.

The esteemed panelists for this discussion were Dr Ranjit Barshikar, CEO – QbD International; United Nations Adviser – Geneva; Dr Rajiv Desai, Executive VP – Corporate Quality, Lupin; Dr Sanjay Kumar Jain, President – India, Amneal Pharmaceuticals; Dr BM Rao, Head of Quality for Emerging Markets, ASAT & Corporate Quality Control, Dr Reddy’s Laboratories; and Ranjith Ramakrishnan, Head Quality Control Biologics – Syngene.

Pointing out that the pharma industry needs to be in a state of continuous, steady improvement, to spur progress in medical science, the panelists drew attention to the advancements in lab technology, equipment, powered by emerging technologies and digital technologies. The discussion also addressed several crucial aspects such as impact of Pharma 4.0, strategies to implement digitalisation in labs, regulatory perspectives/guidelines for pharma labs, and the way forward for progress.

The moderator, Dr Barshikar, steered the discussion through various pertinent issues such as the importance and challenges of data management in pharma companies, their role in enabling high standards of quality and regulatory compliance, digitalisation and automation of pharma labs and more. The panelists discussed and deliberated on the need for complete control over lab data to ensure data integrity, cope with stringent regulatory requirements, improve productivity, as well gain valuable insights for faster scientific breakthroughs. They also highlighted how these factors are driving the industry to create paperless and automated labs.

Discussing the advantages of various tools like Electronic Lab Notebook (ELN), Laboratory Information Management Systems (LIMS), robotic workstations, data repositories, etc, they also shared insights on how to choose the right solutions for their organisation’s needs. They also discussed how automation has ushered new efficiencies in lab activities like data collection and analysis, sample logging, tracking and analysis, instrument integration, report generation, etc.

The experts also acknowledged that high implementation costs, fear of failure, a resistance to change, lack of a clear strategy etc are hindering the adoption of digital labs in the industry. But, they urged the industry to find ways to circumvent these challenges as paperless laboratories will help them to gain the regulators’ trust and build a culture of accountability.

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