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

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

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

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

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

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

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

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 organizations digital maturity