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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 CaliberBRM?

In the field of pharmaceutical manufacturing, it is essential to accurately capture activities on the production floor in real time to uphold quality standards and adhere to regulations such as 21 CFR Part 11 and Good Manufacturing Practices (GMPs). The use of an automated system ensures that batch records are devoid of errors and can be readily accessed, facilitating the monitoring of batch manufacturing procedures. Electronic Batch Record (EBR) systems, like CaliberBRM, supplant conventional paper documentation, thereby reducing risks and safeguarding data integrity and product quality. In highly regulated sectors, particularly within life sciences, the necessity of recording the 4Ms in real time becomes evident as it enhances business processes. The shift to digital batch production records can greatly diminish both time and effort. The EBR system offers thorough oversight of the 4Ms, which helps organizations to cut down on inventory waste, improve workforce management, efficiently handle instruments, and accelerate review cycles, ultimately resulting in lower operational costs. Additionally, Quality Review Management (QRM) highlights the significance of exception-based reviews, which not only expedite batch releases but also boost overall productivity. By adopting these innovative solutions, businesses can cultivate a more flexible and responsive manufacturing landscape, fostering continuous improvement and adaptability in their operations.

Media

Media

Integrations Supported

CaliberPulse
CalibereLog

Integrations Supported

CaliberPulse
CalibereLog

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

Caliber Technologies

Date Founded

2001

Company Location

India

Company Website

caliberuniversal.com/solutions/batch-record-management/

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

Manufacturing Execution

Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability

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