Still relying on spreadsheets, paper records and disparate data systems? Enterprise systems too costly?

Introducing Skyland PIMS®

PIMS™ provides emerging and global drug sponsors and CMOs a collaborative, end-to-end workspace to seamlessly combine product, process and patient data management with analytics, charting and CPV reporting.

Cloud-Based | Deployed in Hours | Intuitive | No Training Needed | 21 CFR Part 11 Compliant

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Why Skyland PIMS®?

Easily Manage Product, Process and Batch Data

Manages product and process specifications and target control limits for in-process and final batch data

Accelerate CPV and APR Planning and Reporting

Maintains a complete change history for specs and limits with full audit trail, rationale and document attachments

Traditional “Tech Transfer” Disappears

Speeds partner on-boarding and functions as the perpetual data library throughout the product lifecycle

Seamless Analytics

Generates segmented control charts and process capability by linking batch data with associated specs and target control limit versions

Enhance Data Visibility

Provides you and your manufacturing partners a secure, collaborative workspace with unlimited, role-based users

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.).

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From R&D through early phase clinical, development and commercial manufacturing, Skyland PIMS® meets the requirements of life science organizations of all sizes managing product, process and patient data.

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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– New

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 – New

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.

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