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ease
features
design
support

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Description

From the viewpoint of managing cell production, organizations aim to oversee every aspect of the production process, including the collection of samples, procurement of raw and auxiliary materials, utilization of instruments and equipment, staffing, environmental conditions, and procedural elements, to optimize resource efficiency. This approach ensures that resources are neither in excess nor deficient, while also upholding the quality of production. Beyond addressing these management challenges, bio cellmes offers a comprehensive system for tracking products and managing the entire production workflow, which encompasses everything from initial job preparations and the production stages to final clearance processes. Additionally, the quality control aspect involves thorough inspections of both product and reagent quality, while quality assurance entails monitoring environmental factors, managing deviations, and conducting audits for the release of finished products, ensuring a robust and reliable production framework. Ultimately, this integrated system not only enhances operational efficiency but also contributes significantly to maintaining high standards in production quality.

Description

Skyland PIMS® offers a comprehensive solution for managing both product and process data from end to end. This collaborative platform is designed for both emerging and established global drug sponsors and contract manufacturing organizations (CMOs), enabling them to effectively handle essential development, manufacturing, and quality information. With its cloud-based architecture and validatable software, the system ensures quick implementation and reduced total cost of ownership (TCO). It allows users to maintain data consistency, comprehension, and oversight throughout the supply chain, resulting in quicker and more effective scale-ups, technological transfers, and commercial launches. Users can easily capture batch information and utilize summary dashboards for effective data monitoring, release tracking, analysis, and reporting. The platform also simplifies the management of product and process specifications along with target control limits while enabling effortless audit trail creation. Furthermore, it seamlessly integrates batch and limits data to generate insightful process analysis and control charts. Compliance with CPV/APR reporting requirements is made straightforward, all while maintaining a persistent library of product and process data that supports transparency and integrity across global networks. By streamlining data management throughout the product lifecycle and supply chain, Skyland PIMS® enhances operational efficiency and collaboration among stakeholders. This innovative approach not only improves regulatory compliance but also fosters a culture of continuous improvement within organizations.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Bio LIMS

Founded

2016

Website

www.biolims.net

Vendor Details

Company Name

IDBS

Founded

1989

Country

United Kingdom

Website

skylandanalytics.net

Product Features

Product Features

Manufacturing Intelligence

Aggregation
Analysis
Contextualization
KPIs
Propagation
Visualization

SPC

Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance

Statistical Analysis

Analytics
Association Discovery
Compliance Tracking
File Management
File Storage
Forecasting
Multivariate Analysis
Regression Analysis
Statistical Process Control
Statistical Simulation
Survival Analysis
Time Series
Visualization

Alternatives

Alternatives

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