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.
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Overcoming manufacturing data challenges
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):
- Visualization and analytics of relevant batch data for CPV & APQR support, investigations and process optimizations and process monitoring across the manufacturing network
- Collaboration and data sharing with manufacturing sites, both captive and outsourced
- Simple integration and contextualization of data from key systems like EBR, MES, LIMS, Historians, QMS, ERP, etc
“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
Benefits reported by PIMS’ customers
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:
Reduced batch failure
- Holistic view of how the processes are performing within performance specifications (pass/fail metrics) and QA targets and controls
- Daily process monitoring for early detection of issues that could lead to batch failure
Large manufacturer uses PIMS to help identify potential manufacturing issues quickly thereby saving what would have ended in full or partial lost batches.
Decreased regulatory reporting burden
- All critical quality and process data (CPPs, CQAs, etc.) are captured on a batch-by-batch basis
- Easy access to required process monitoring and analytical outputs for both CPV and APQR filings
- Quick generation of required outputs on demand during on-site regulatory audits
Estimated 50% reduction in regulatory report preparation time.
AAV vector gene therapy customer
Decreased investigations burden
- Batch data instantly available to identify trends and investigate root causes of critical deviations
- Pre-organized and contextualized data from multiple sources for easy and quick access by process experts
- Holistic view of captive data alongside manufacturing partner data
PIMS Analytics module reported to reduce deviation investigation time by 70%
AAV vector gene therapy customer
Enhanced process optimization
- Batch data instantly available for both process monitoring and golden batch comparisons
- Supports scale-up through capture and application of optimized target control and process specification limits
- Data is easily available to external statistical tools like Minitab, Power BI, SAS JMP and Statistica for further analysis
“Process Engineers are able to spend more time on the process vs. data collecting and graphing.”
2022 Interview with large CDMO customer
Faster validation
- Validation is accelerated with the PIMS Validation Kit
- Additionally, IDBS Professional Services can perform IQ and OQ in as little as 3 to 4 weeks, leaving only PQ for the customer, typically completed in less than 8 weeks
“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
Enhanced collaboration between CDMOs/CMOs and sponsors
- Sponsors can receive secure, real-time data transmission of batch and quality data along with CofAs from external manufacturing partners
- CDMOs/CMOs can decrease manual data preparation and reporting whilst providing an enhanced service to sponsors
“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
Why choose PIMS
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).
- In-house PIMS experts have > 30 years of biologics manufacturing experience
- PIMS customers are advocates for its ease of deployment, simplicity of use and the time savings and ROI it has brought them. Read our Customer Stories
- PIMS is designed to minimize IT and maintenance costs, allowing business experts to undertake accurate configuration and easy validation
- PIMS is designed to scale regardless of your organization’s digital maturity
Related articles and reports
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Join our customers on the road to faster innovation
Why our customers choose IDBS
Best-in-class technology
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.
Accelerate productivity
Our solutions have been designed with extensibility and integration in mind, enabling easy data capture adapted to how scientists work and ensuring data integrity.
Data driven insights
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 us
Contact one of our specialists to hear more about the competitive advantage you can gain with PIMS