In 2022 The Paperless Lab Academy will host the third edition of its conference in India but it will be the first time that a live, in-person event has been possible. The event will showcase discussions to help laboratory organisations to implement paperless technology and strategies for digital transformation.
The event organisers aim to provide a platform to discuss key milestones to generate business insights. While also connecting like-minded experts who can share their experience and best practices for digitisation and digital transformation.
Sachin Bhandari is one of the expert speakers lined up for the PLA India keynote presentations. His talk, “Milestones of a digital transformation journey” will highlight key points on the journey towards lab digitisation and share experience gained from carrying out this process at SunPharma.
With more than 20 years of experience in Pharmaceutical and healthcare compliance, Sachin is now SunPharma’s Senior General Manager (Global Head QA-IT & Quality Digitisation Projects). He is responsible for IT compliance and helps to lead quality initiatives pertaining to IT and the readiness of the organisation for IT compliance.
“I've been with Sun Pharma for almost eight years now. And primarily my job is to make sure that our IT systems stay compliant at all times. I take care of QA-IT compliance, and also drive the digitisation of CSV processes for Sun Pharma and the digitisation projects for our QA/QC, and IT compliance,” states Bhandari.
Sachin has considerable experience in GXP, 21 CFR part 11, Annex -11, GAMP 5 compliance (Validation and Quality). He has primarily worked on validation activities related to quality systems, lab systems validation, IT infrastructure validation, supply chain validation, quality systems and service desk compliance.
“Digital transformation is an investment. Digitisation gives you an opportunity to re-invent your processes. It helps you to optimise and make those processes more aligned with the changing business needs - that's how I look at it. This is an investment which has a very high return,” Bhandari continued. “Digitisation improves compliance, and all of us in the pharma industry know what is the cost of non-compliance. It helps us to improve our level of compliance, and it makes overall compliance faster and more efficient.”
Sachin is currently driving paperless initiatives at SunPharma. Supporting the implementation of technological innovations to improve quality and compliance. Sachin was Chairman of ISPE GAMP steering committee India Chapter and is a prominent speaker at various forums and seminars.
“The Paperless Lab Academy is a very exciting opportunity because the lab forms a very critical part of our entire quality gamut. In addition, a lot of organisations have different approaches towards achieving a paperless lab. If we look at my talk, for example, it's about the milestones in achieving this kind of transition towards digital transformation and the paperless laboratory.”
“Different organisations will be at different stages. When you talk about the different milestones it's not a turnkey approach, it's a process, comments Bhandari. “In my talk, I will consider the reasoning behind SunPharma’s decision to adopt digital technology. An organisation must consider the different steps or milestones that they need to achieve. That will help people to understand where they are, and the roadmap ahead.”
While there are many paths towards digital transformation Bhandari highlights several milestones that can be crucial steps for lab-based operations. “Have you digitised all your instruments? Is your quality analysis digitised? Are you using artificial intelligence and robotic processes to assist in compliance? I will also discuss the key pitfalls and challenges which can come in at various milestones, when you go from one level to another.”
The advice and expertise that can support digital transformation is now becoming more readily available for lab users and managers that want to begin the process within their own organisation. Bhandari notes that there have been three main changes that have caused this shift towards digitisation.
He describes how in the past professionals thought that digitisation just meant converting processes from paper-based systems to digital. However, Bhandari stresses that if thought out properly, digitisation provides an opportunity to re-invent processes and increase operational efficiency. “Now they have started to understand that it is a lot more than that. That's the number one change.”
“Second it used to be true that we did not have the vendors, or the business analysts available in the market. We had IT guys who did not understand pharma and pharma guys who did not understand IT, said Bhandari. “Today, we have lots of business analysts, and a lot of use cases already available in the market. We have vendors with products that are configurable and can be easily deployed. This was not there, but now we have a lot of choices.
“Third, I think the manufacturers have started to understand that they need to have more open interfaces so that their data can be part of data lake and data analytics. Previously the market was dominated by closed systems,” stated Bhandari. Now they have started opening up a bit, not everything is proprietary. These are the three primary changes, I have come across.”
This year’s PLA India event promises to be a melting pot of ideas, expertise and knowledge sharing focusing on paperless lab technologies and digitisation. Like many other participants, Bhandari is looking forward to the knowledge exchange and a chance to share the experiences of his contemporaries.
“I'm looking forward to very interesting knowledge exchanges because there is no single set formula for digitisation. I know almost all Indian companies are participating. I'm looking forward to learning from other people, how their journey has been, and the challenges they have faced. If we can create some kind of a knowledge bank where we can exchange our thoughts and learn from each other's mistakes that will be a very positive outcome for all participants.
“I'm very excited to see what other companies are doing, What stage are they are on? I can see there are a lot of good vendors coming in so I want to see what is available from them for 2023?”
