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What is RegDocs Connect?

RegDocs Connect provides operational and regulatory teams with vital tools aimed at producing comprehensive and compliant documents and records that can be easily submitted. This solution is thoughtfully crafted with the user experience as a priority, emphasizing collaboration, automation, and quality at its foundation. The automation of workflows simplifies the entire records lifecycle, from drafting to finalization, ensuring that your team has complete oversight of regulatory documents throughout the process. By integrating document types with the EDM reference model and eCTD, this system significantly improves the organization and retrieval of documents crucial for regulatory submissions. Furthermore, unique features like PDF/A Publishing, document classification, and distinct document identifiers establish a powerful regulatory document management framework that brings together information from various sectors of your organization into one cohesive and navigable solution. As the trend toward electronic submissions to regulatory agencies continues to rise and the complexities of drug development evolve, the ability to produce high-quality, submission-ready content is increasingly vital for maintaining compliance and enhancing efficiency. In addition, this holistic approach not only streamlines the documentation process but also encourages deeper collaboration among teams, which can lead to more successful outcomes in regulatory affairs and improve overall productivity. Such advancements in regulatory document management are essential for adapting to the rapidly changing landscape of compliance requirements.

What is CaliberPulse?

CaliberPulse is a state-of-the-art analytical platform tailored for the pharmaceutical industry, designed to transform complex data into actionable insights that improve operational efficiency and uphold compliance in quality assurance and manufacturing operations. This innovative platform features built-in reporting tools that provide instant insights into statistical process control and quality metrics, specifically addressing the unique needs of the pharmaceutical sector. By seamlessly connecting with applications like MS Excel, LIMS, EBR, and SAP, it facilitates efficient data extraction and real-time reporting, significantly reducing the reliance on manual data entry. Additionally, CaliberPulse comes equipped with advanced features such as automated Box-Cox data transformation, critical attribute evaluations, and extensive data visualization capabilities that present results in an easily digestible format through graphical displays and color-coded interfaces. Moreover, the system ensures compliance with regulatory standards by automating data ingestion and storage processes, while preserving complete traceability throughout the data lifecycle. This combination of features not only enhances the accuracy of data management but also fosters a culture of informed decision-making within pharmaceutical organizations, ultimately allowing them to navigate their regulatory landscape with greater assurance and effectiveness. Through its comprehensive approach, CaliberPulse truly empowers these organizations to harness the full potential of their data for strategic advancements.

Media

Media

Integrations Supported

CaliberBRM
CaliberLIMS
Microsoft Excel
Montrium Connect
SAP Cloud Platform

Integrations Supported

CaliberBRM
CaliberLIMS
Microsoft Excel
Montrium Connect
SAP Cloud Platform

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

Montrium

Company Location

Canada

Company Website

www.montrium.com

Company Facts

Organization Name

Caliber Technologies

Date Founded

2001

Company Location

United States

Company Website

caliberuniversal.com/solutions/caliber-pulse/

Categories and Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Categories and Features

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