Still relying on spreadsheets, paper records and disparate data systems? Enterprise systems too costly?
Introducing Skyland PIMS®
PIMS™ provides clinical and commercial-stage bio/pharma developers and manufacturers a collaborative, end-to-end workspace to seamlessly combine product, process and patient data management with analytics, charting and continued process verification (CPV) reporting.
Cloud-Based | Deployed in Hours | Intuitive | No Training Needed | 21 CFR Part 11 Compliant
Manage product and process specifications and target control limits for in-process and final batch data
Maintains a complete change history for specs and limits with full audit trail, rationale and document attachments
Speeds partner on-boarding and functions as the perpetual data library throughout the product lifecycle
Generates segmented control charts and process capability by linking batch data with associated specs and target control limit versions
Provides you and your manufacturing partners a secure, collaborative workspace with unlimited, role-based users
One collaborative workspace. Five integrated modules.
PIMS Batch™
Manages batch data verification settings which can be pre-configured to flag out of range values. Provides approval workflows and dashboards to monitor data entry and batch release status.
PIMS Limits™
Manages product and process specifications and target control limits. Provides an audit trail of changes, authors, approvers, date and rationale. Contextualizes data to feed analysis and reporting.
PIMS Analytics™
Seamlessly integrates batch data with specification and target control limit versions to produce segmented control charts and process Capability to fulfill the FDA’s CPV reporting requirements.
PIMS Raw Materials™
Quickly track, trace, and compare unlimited raw material quality and performance across vendors, lots, processes, and products. Provides genealogy tracking of material components in intermediaries and solutions through final product.
PIMS Stability™
Centralize data from different steps in the drug development process and forecast product expiration dates and shelf life for the drug approval process. Substantially reduces time spent by critical staff in manufacturing, finance, capacity planning, and supply chain operations.
The transition from biopharmaceutical manufacturing development to full-scale manufacturing often represents a breakpoint in data management and its application. Skyland PIMS and Polar will enable IDBS to extend its BPLM coverage seamlessly from candidate identification through manufacturing in a highly regulated ecosytem.
Bringing IDBS Polar and Skyland PIMS together will formulate the world’s first end-to-end data management system for biopharmaceuticals. Development data and manufacturing data can co-exist in the same operational space and drive deeper insight, increasing operational efficiencies and accelerating time-to-market for novel therapies.
For the first time, process data and knowledge can be efficiently integrated throughout all stages of the lifecycle, helping to navigate the complex supply chains and collaborations needed to deliver life-changing therapies to patients.