About Skyland PIMS
A cloud-based process data management software for BioPharma companies. It provides a collaborative workspace to manage product, process, and patient data, with features for analytics, charting, and CPV reporting.
Skyland PIMS is a specialized, cloud-based data management and analytics platform for the biopharmaceutical industry. It provides a centralized, 21 CFR Part 11 compliant workspace for managing product, process, and patient data throughout the product lifecycle. The software is designed to replace spreadsheets and disparate systems, offering modules for batch data management, specification and limit control, process analytics, raw material tracking, and stability studies. It aims to accelerate tech transfer, improve data integrity, and streamline the preparation of regulatory reports like Continued Process Verification (CPV). Skyland PIMS is a SaaS product that can be deployed quickly. Pricing is not publicly available and requires a demo request. Support is available via phone and email. The platform is targeted at life science organizations, from emerging biotech to global pharmaceutical companies and their contract manufacturing partners (CMOs).
Pros & Cons
- Specifically designed for the BioPharma industry's data management needs.
- Helps ensure 21 CFR Part 11 compliance with features like audit trails.
- Cloud-based deployment allows for quick setup without extensive IT infrastructure.
- Facilitates collaboration between sponsors and contract manufacturing organizations (CMOs).
- Integrates various data sources into a single, validatable platform.
- Pricing information is not publicly available and requires contacting the vendor for a demo.
- The software is highly specialized for the life sciences, making it unsuitable for other industries.
- No free trial or free tier is mentioned on the website.
Features
Key features
Manages batch data verification settings with approval workflows and dashboards to monitor data entry and release status.
Manages product and process specifications and target control limits, maintaining a full audit trail of changes.
Integrates batch data with specifications to produce segmented control charts and process capability analysis for CPV reporting.
Tracks and compares raw material quality and performance across vendors, lots, and products, including genealogy tracking.
Centralizes data from drug development to forecast product expiration dates and shelf life for regulatory approval.
Additional features
Provides a secure, shared environment for internal teams and external partners with role-based user access.
Combines data from various sources including LIMS, MES, EBR, historians, and manual entry into a single platform.
Functions as a perpetual data library to speed up partner on-boarding and scale-up processes.
Designed to meet the requirements of 21 CFR Part 11 for life science manufacturing.
A SaaS solution that can be deployed in hours without requiring customer IT infrastructure.
Maintains a complete change history for specifications and limits, including rationale and document attachments.
Enhances data visibility across the supply chain, including sponsor-CDMO/CMO networks.
Facilitates the preparation of regulatory submissions like CPV, APRs, and CMC sections.
Pricing
Countries & Languages
Interface languages
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About Skyland PIMS
A cloud-based process data management software for BioPharma companies. It provides a collaborative workspace to manage product, process, and patient data, with features for analytics, charting, and CPV reporting.
Skyland PIMS Details
Skyland PIMS's In-App Market Place
Does Skyland PIMS have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
0
Mini Apps
Pricing Options
Accepted Payment Currencies
Pros & Cons
- Specifically designed for the BioPharma industry's data management needs.
- Helps ensure 21 CFR Part 11 compliance with features like audit trails.
- Cloud-based deployment allows for quick setup without extensive IT infrastructure.
- Facilitates collaboration between sponsors and contract manufacturing organizations (CMOs).
- Integrates various data sources into a single, validatable platform.
- Pricing information is not publicly available and requires contacting the vendor for a demo.
- The software is highly specialized for the life sciences, making it unsuitable for other industries.
- No free trial or free tier is mentioned on the website.
Skyland PIMS's Support Options
Email Address
info@skylandanalytics.netContact
(720) 773-8800Skyland PIMS's Alternatives
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