The process is no longer the product. Data is the new deliverable.
Making data a core deliverable means the right people need to collect information and connect disparate data points through a well-structured data backbone.
PIMS (Process Information Management System) is 21 CFR Part-11 compliant, cloud-native software that creates a contextualized data backbone of critical manufacturing process and quality data across products and batches.
This addresses critical requirements for all BioPharma manufacturing (small and large molecules and new modalities):
“We needed to move fast on our COVID-19 vaccine, replace Excel data management and accelerate CMO data sharing, PIMS was the perfect product.”
Director of Data and Analytics, Novavax
PIMS customers report transformation of their Process Monitoring, Investigations, and Tech Transfer through automated data management and insights.
Customers gain value in the following areas:
Large manufacturer uses PIMS to help identify potential manufacturing issues quickly thereby saving what would have ended in full or partial lost batches.
Estimated 50% reduction in regulatory report preparation time.
AAV vector gene therapy customer
PIMS Analytics module reported to reduce deviation investigation time by 70%
AAV vector gene therapy customer
“Process Engineers are able to spend more time on the process vs. data collecting and graphing.”
2022 Interview with large CDMO customer
“Using PIMS’ comprehensive validation kit, the Company will save up to 80% of the time traditionally spent on validation efforts and move into a validated state in weeks.”
Leading biotech customer
“With both captive and CMO data being easily configured and analyzed in one place, the Company will meet its need for supply chain visibility and site-to-site comparisons in the same repository rather than constantly checking between paper and Excel and different versions of the truth..”
Leading biotech customer
PIMS will help you create a single source of manufacturing data quickly and with minimum resource investment so your organization can gain insights that reduce production costs, reduce batch failures, smooth validation and remove business and regulatory reporting roadblocks to accelerate your Time-To-Market (TTM).
Making data a core deliverable means the right people need to collect information and connect disparate data points through a well-structured data backbone.
Explore the benefits of GxP computer systems to improve time-to-value so that companies can speed up the development and manufacture of life-saving drugs.
IDBS reveals new process definition-handling capabilities in PIMS 5.0, which enhance quality assurance and validation for pharma manufacturers.
IDBS offers best-in-class cloud-based software solutions based on over 30 years of experience and collaboration with 18 out of the top 20 global BioPharma companies. Industry-leading security and compliance: 21 CFR 11 / GxP compliant.
Our solutions have been designed with extensibility and integration in mind, enabling easy data capture adapted to how scientists work and ensuring data integrity.
Whether you are striving to better understand the performance of your equipment and processes or looking to transform the way you work with model-based insights, our software solutions can help.
Contact one of our specialists to hear more about the competitive advantage you can gain with PIMS