Cell & Gene Therapy: Easily and Confidently Centralize, Analyze and Share Product, Process and Patient Data Across Your Supply Chain
Developers of cell and gene therapies are increasingly looking at enhancing their clinical and commercial process data management approaches to address the challenges associated with more complex manufacturing processes, the explosion of data, short production timelines and global supply chains (CDMOs, CMOs, QC testing houses, logistics companies, etc.).
From collection of unique raw materials during apheresis through batch production to clinical endpoint data, Skyland PIMS® provides a 21 CFR Part 11 compliant, centralized platform to establish common data structures, traceability and transparency while strengthening communication and collaboration across teams, sites and partners.
PIMS™ breaks down data silos and ensures data transparency and traceability among internal teams as well as external partners throughout the development and production supply chain.
Process: Create and Manage Process Definitions
Batch: Expedite Batch Data Entry and Approvals
Limits: Manage Specifications and Target Control Limits
Analytics: Generate Charts, Reports and Alerts
Raw Materials: Track Ingredient Quality Data
Stability: Forecast Drug Expiration Dates and Shelf Life
We have data everywhere in different formats. PIMS enables us to bring this data into one validatable space.
Ultimately the big value is the data repository, streamlined batch review and verification, and knowing what data can be trusted.
We needed a solution that allows for greater levels of data integrity and scale in terms of being able to generate and analyze even more batches as we go forward. We use Skyland PIMS to form the process knowledge base for the CMC section for our BLA.
Persistent Knowledge Base
Serving as a persistent product and process data library, Skyland PIMS ensures process knowledge is maintained across the supply chain and throughout the product life cycle. PIMS tracks changes to process and product specifications and target control limits with a full audit trail of authorship, timestamp and rationale. PIMS also supports document attachments, comments, URLs and flowcharts for additional context
Enhanced Data Integrity
With no custom coding required, PIMS’ automatic derived values and digital query capabilities together with its intuitive data entry and approval workflows provide higher levels of data integrity compared to Excel and bespoke solutions.
Accelerated, Actionable Insights
Skyland PIMS makes efficient use of scarce resources with its unique Data Cascade™ functionality providing data contextualization throughout required data sets enabling rapid automatic data analytics and charting for KPIs, continuous process verification (CPV), preparation of APRs, process optimization, process validation, and batch release.
Skyland PIMS was purpose-built to meet your technical requirements:
- Cloud-Based
- Controlled & Secure Data Sharing
- 21 CFR Part 11 Compliant
- Validatable
- Persistent Knowledge Base
- User Friendly
- Easily Configurable
- Minimal IT Involvement
- Digital Data Source Connectivity
- Rapid Deployment
- Scalable to Fit All IT Landscapes
- Low Total Cost of Ownership
- Intuitive Workflows
- No Coding
