Skyland PIMS - Process Information Management System Software for BioPharma Manufacturing
Skyland PIMS is an advanced cloud-native Process Information Management System (PIMS) developed to meet the stringent requirements of the BioPharmaceutical manufacturing sector, accommodating both small and large molecules along with new modalities. As a 21 CFR Part-11 compliant software, PIMS offers a robust data backbone that contextualizes critical process and quality data across different products and batches. The system is designed to streamline various manufacturing processes including batch monitoring, regulatory reporting, deviation investigation, process optimization, and validation support. By automating data management and facilitating efficient data sharing, PIMS enables significant reductions in batch failures, regulatory reporting burdens, and deviation investigation times. It provides enhanced visibility and optimization capabilities that can lead to faster validation and significant resource savings. In essence, PIMS serves as a vital tool for BioPharma companies aiming to enhance their manufacturing efficiency, data integrity, and compliance with industry regulations.
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
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