Skip links

Event Recap: ISPE Indonesia & Factorytalk Seminar: GxP Quality & Manufacturing Digitization

On 1st September 2022, Factorytalk and ISPE Indonesia organized a GxP Quality & Manufacturing Digitization seminar. The aim of this seminar was to update on the latest technology, digitization and IT approaches, and related regulatory insights in the GxP domain. More than 50 participants from various pharmaceutical companies in Indonesia joined in this one day seminar, where we covered several topics included:
  • Importance of QMS and current regulatory position and expectations
  • Global regulatory and best practices update
  • Challenges and opportunities in pharma digitalization
  • Quality aspects of GxP digitalization
  • Approaches to GxP digitalization
  • eQMS and EBR in 2022
Alongside the seminar, there were displays of Factorytalk products built explicitly for the pharmaceutical industry.

electronic Quality Management System (eQMS) – MasterControl

MasterControl, a robust eQMS, offers a variety of modules to manage quality-related activities electronically. Document Management and Quality Events Management are notable modules, though customers usually include additional modules to fit their business and compliance needs, e.g., Training Management, Audit Management, etc. In addition, to minimize the exhausting validation work, MasterControl is built to be highly configurable to avoid unnecessary customization and offers a Validation Excellence Toolkit where most tests are done automatically, leaving only minimal work for your validation team.

Electronic Batch Record System (EBR) – BatchLine

BatchLine, an effective Electronic Batch Record System, guides operators with sequential-controlled instructions; while allowing operators to either manually or automatically capture the output. Since BatchLine comes with 3rd party system integration capability, one of the highly recognized use cases of BatchLine is integrating BatchLine with an ERP system for Weighing and Dispensing. That said, BatchLine will automatically retrieve the weight of raw materials from the scale, then send data to ERP for material consumption and automatically update the remaining stock of each material. The system also includes an audit trail and e-signature functions to ensure GMP compliance and built-in analytics to monitor productivity and compliance matrix in real-time.

Frontline Operations Platform (FOP) – Tulip

Tulip is a no-code platform that allows users to create applications using the drag-and-drop approach. You can imagine Tulip as a digital putty to fill the gaps among other systems already implemented or replace legacy software if needed. Converting complicated paper SOPs into the digital version with rich media like animated GIFs or short videos is commonly used among pharmaceutical companies to reduce human error and shorten onboarding courses. Another popular application of Tulip is to create a Total Productive Maintenance app suite with real-time analytics for the planned maintenance across the shop floor. Following the success of GxP Quality & Manufacturing Digitization seminar, David Margetts, CEO of Factorytalk comments:
“It was fantastic to host this in-person event after the last years of Covid restrictions and not being able to engage personally with our clients from the Pharma industry in Indonesia. We had a great audience participation with lots of interesting views and questions to our esteemed panel around the theme of how to move Digitisation forward, thank you to all the people who joined us and made the event happen and we look forward to seeing you again soon.”
The Factorytalk team would like to thank all participants who joined in our first in-person seminar after the pandemic and we are looking forward to seeing you again in our next event.

Leave a comment