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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 Agatha?

Agatha offers a wide array of cloud-based solutions meticulously tailored for the life sciences industry, which enables the centralized management of documents and processes associated with clinical operations, quality assurance, regulatory compliance, and training initiatives. This innovative platform is designed to support the unique workflows of biotech companies, pharmaceutical enterprises, medical device producers, and contract research organizations, providing various modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for developing and approving standard operating procedures (SOPs), in addition to managing quality documents for CAPAs, deviations, and change controls. Furthermore, Agatha streamlines the handling of regulatory documents, ensuring the seamless creation, review, approval, storage, and sharing of materials within an integrated system. By advocating for a paperless environment, it reduces administrative burdens and enhances data security, all while being built on a framework that adheres to global compliance standards like 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha equips life sciences organizations with the tools necessary to refine their operations and uphold adherence to industry regulations more effectively, paving the way for improved efficiency and innovation in the sector. With its robust features, the platform not only simplifies complex processes but also supports organizations in achieving their strategic goals.

Media

Media

Integrations Supported

APSentra
Nextbitt
SAP Joule
Streams.AI by PanTerra Networks
TrueCommerce

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Online 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

Agatha

Date Founded

2015

Company Location

United States

Company Website

en.agathalife.com

Categories and Features

Life Sciences

Not specified

Categories and Features

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