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What is SAP Advanced Track and Trace for Pharmaceuticals?

Protect your business and comply with the diverse drug serialization requirements and fast-changing regulations of different countries while adeptly handling large volumes of data through intelligent solutions. Leverage the SAP Advanced Track and Trace for Pharmaceuticals application to uphold adherence to both global and regional laws, as it boasts a thorough serialization database, effective serial number oversight, and strong regulatory reporting capabilities. Reduce the expenses linked to compliance for both existing and upcoming serialization responsibilities, which include tailored reporting needs for numerous countries. Boost the efficiency of your supply chain by obtaining comprehensive insights into material movement, right down to the individual sales-unit-item level. Skillfully manage extensive serialization data while remaining flexible enough to adapt to new legislative updates. Ensure control over retail product serial numbers through a centralized corporate database, confirming adherence to all country-specific requirements for reporting these serial numbers. By putting these practices into action, your organization can not only optimize its operations but also maintain a competitive edge in the marketplace. Additionally, this proactive approach will position you favorably for future regulatory changes and market demands.

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.

Media

Media

Integrations Supported

Montrium Connect
Nextbitt
SAP Joule
Streams.AI by PanTerra Networks
TrueCommerce

Integrations Supported

Montrium Connect
Nextbitt
SAP Joule
Streams.AI by PanTerra Networks
TrueCommerce

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

SAP

Date Founded

1972

Company Location

Germany

Company Website

www.sap.com/products/track-trace-pharmaceuticals.html

Company Facts

Organization Name

Montrium

Company Location

Canada

Company Website

www.montrium.com

Categories and Features

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

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