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What is Skyland PIMS?

Skyland PIMS® presents a holistic approach to managing product and process data from start to finish. This collaborative platform caters to both new and established global drug sponsors as well as contract manufacturing organizations (CMOs), enabling them to efficiently manage critical information related to development, manufacturing, and quality assurance. With its cloud-based framework and validatable software, it offers rapid implementation and lowers the total cost of ownership (TCO). The system helps maintain data consistency, clarity, and oversight throughout the entire supply chain, leading to faster and more effective scaling, technology transfers, and market launches. Users can effortlessly capture batch details and leverage summary dashboards for efficient data monitoring, release tracking, analysis, and reporting. Additionally, the platform simplifies the oversight of product and process specifications, along with target control limits, while facilitating easy audit trail generation. Moreover, it adeptly integrates batch and limits data to produce valuable process analysis and control charts. Compliance with CPV/APR reporting mandates is straightforward, all while upholding a continuous library of product and process data that ensures transparency and integrity across international networks. By optimizing data management across the product lifecycle and supply chain, Skyland PIMS® bolsters operational efficiency and strengthens collaboration among stakeholders. This cutting-edge approach not only enhances regulatory compliance but also encourages a culture of ongoing improvement within organizations, ultimately leading to better outcomes in drug development and manufacturing. As a result, stakeholders can expect increased productivity and a more responsive supply chain.

What is Nova-Cleaning Validation?

Nova-Cleaning Validation software is essential for enhancing product integrity by adeptly handling changes and assessing the risks related to cross-contamination and impurities in a dynamic production environment. It diligently examines every modification concerning methods, APIs, products, equipment, and family groups to maintain product integrity while ensuring compliance with regulatory requirements. In addition, Nova-Cleaning Validation complies with the stipulations outlined in 21 CFR Part 11 and EU Annex 11, which further solidifies its reliability. The system utilizes a risk-based approach and is thoroughly designed in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, positioning it as a trusted option for quality assurance in the pharmaceutical sector. This all-encompassing strategy not only protects product quality but also boosts the overall efficiency of the manufacturing process, ultimately leading to more reliable outcomes for stakeholders. By continuously adapting to new challenges in the industry, it ensures that the highest standards of quality are consistently met.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

IDBS

Date Founded

1989

Company Location

United Kingdom

Company Website

skylandanalytics.net

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.com

Categories and 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

Categories and Features

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

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