PIMS

IDBS PIMS (Process Information Management System) is a 21 CFR Part 11-compliant, cloud-native software platform designed to create a contextualized data backbone of critical manufacturing process and quality data across products and batches. It is built for BioPharma manufacturers working with small and large molecules as well as new modalities, helping them make manufacturing process data accessible, transferable, and meaningful across their entire production network.

PIMS addresses three core manufacturing data challenges: providing visualization and analytics of batch data to support Continued Process Verification (CPV) and Annual Product Quality Reviews (APQR), enabling collaboration and data sharing across captive and outsourced manufacturing sites, and simplifying integration and contextualization of data from key enterprise systems including EBR, MES, LIMS, Historians, QMS, and ERP platforms.

Batch Monitoring

• Provides a holistic view of how processes are performing within performance specifications, including pass/fail metrics and QA targets and controls
• Enables daily process monitoring for early detection of issues that could lead to batch failure
• Helps large manufacturers identify potential manufacturing issues quickly, preventing full or partial batch losses

Regulatory Reporting

• Captures all critical quality and process data — including Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) — on a batch-by-batch basis
• Provides easy access to required process monitoring and analytical outputs for both CPV and APQR filings
• Enables quick generation of required outputs on demand during on-site regulatory audits
• Customers have reported an estimated 50% reduction in regulatory report preparation time

Deviation Investigation

• Makes batch data instantly available to identify trends and investigate root causes of critical deviations
• Delivers pre-organized and contextualized data from multiple sources for rapid access by process experts
• Provides a holistic view of captive data alongside manufacturing partner data
• The PIMS Analytics module has been reported to reduce deviation investigation time by up to 70%

Process Optimization

• Batch data is instantly available for process monitoring and golden batch comparisons
• Supports scale-up through capture and application of optimized target control and process specification limits
• Data can be easily exported to external statistical tools including Minitab, Power BI, SAS JMP, and Statistica for further analysis
• Frees process engineers from manual data collection and graphing, allowing more time to focus on the process itself

Validation Support

• Validation is accelerated through the PIMS Validation Kit, which customers report can save up to 80% of the time traditionally spent on validation efforts
• IDBS Professional Services can perform Installation Qualification (IQ) and Operational Qualification (OQ) in as little as 3 to 4 weeks
• Performance Qualification (PQ), left to the customer, is typically completed in under 8 weeks
• Enables organizations to move into a validated state within weeks rather than months

Partner Collaboration

• Sponsors can receive secure, real-time data transmission of batch and quality data along with Certificates of Analysis (CofAs) from external manufacturing partners
• CDMOs and CMOs can reduce manual data preparation and reporting while providing an enhanced service to sponsors
• Captive and CMO data can be configured and analyzed in a single repository, enabling site-to-site comparisons and eliminating reliance on paper, Excel, and multiple conflicting data sources

Why Choose PIMS

• In-house PIMS experts bring more than 30 years of biologics manufacturing experience
• Designed to minimize IT and maintenance costs, allowing business experts to undertake accurate configuration and straightforward validation
• Scalable to suit organizations at any level of digital maturity
• Customers report ease of deployment, simplicity of use, and strong time savings and return on investment
• Helps reduce production costs, decrease batch failures, smooth validation processes, and remove regulatory reporting roadblocks to accelerate Time-To-Market (TTM)

PIMS is a cloud-native solution backed by IDBS, part of Danaher, with a track record of collaboration with 80% of the top 20 BioPharma companies. It is fully GxP and 21 CFR Part 11 compliant, and integrates with a broad range of enterprise systems to serve as a single, authoritative source of manufacturing and quality data across the product lifecycle.