How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

Traceability solution for regulated companies

At GxpManager, we understand how important it is for our clients to ensure the traceability of their products, processes, and data.

Regulatory compliance and traceability: a must

For companies subject to strict regulations (pharma, biotech, food industry, transport, etc.), traceability is not an option but an obligation. It ensures consumer safety, proves the integrity of processes, and guarantees that every product or operation complies with current standards.

What our solutions offer to our clients:

Compliance with strict regulations (e.g., ISO 9001, FDA, etc.).

Management of complex supply chains.

Full transparency in tracking their products and processes.

Risk reduction through enhanced control at every stage.

How GxpManager ensures traceability through its applications

GxpManager applications incorporate powerful features to meet the traceability requirements of regulated companies.

Audit Trail: data traceability

Thanks to the audit trail, all data modifications, creations, and deletions are tracked, providing complete visibility into operations’ history.

Automated workflows: process traceability

Tracking each step in the business process ensures traceability and accurate monitoring of tasks.

Versioning: document and form traceability

Version management ensures document traceability by saving previous versions.

Electronic signature

The electronic signature applies to all the features mentioned. It identifies the author of each modification and guarantees the integrity of data, preventing any changes after signing. It provides irrefutable proof of consent and ensures compliance.

From manual methods to digitalized traceability

Before adopting a digital traceability solution like GxpManager, many companies used manual methods such as paper, Excel® files, or various forms. 

Manual methods present numerous drawbacks

Difficulty maintaining regulatory compliance.

High costs related to paper document storage and management.

Insufficient data security for companies under strict regulations.

Time-consuming procedures are prone to errors.

Benefits of Digitalized Traceability with GxpManager:

Ensure compliance with regulations: Generate reports and traceability proof with a single click.

Simplify audits.

Better overview of your processes

Example client projects

Our traceability solutions have helped many companies in various areas:

The application allows the inventory of systems and equipment, the management of suppliers, system owners, and all associated Quality actors.

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The application enables the planning of cell cultures and ensures the traceability of each associated action.

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Implementation of a custom stock management solution to trace all operational information from reception to delivery, including product destruction.

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The application enables simplified management of quality processes and regulatory compliance with 21 CFR part 11.

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Ready to optimize your data traceability?
Our traceability feature is included in all our applications and,
can be tailored to your needs.

Latest news and novelties

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Medical Device show, 12th edition

Discover our innovative solutions for compliance management, risk analysis, and process digitalization. Visit us at stand 12 to learn how we can optimize your quality management system and streamline your medical device compliance.

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GxpManager at Digital Transformation Week

Visit us at Booth 262 on October 1-2 at the RAI Amsterdam Convention Centre. Explore our innovative No-Code/Low-Code solutions for compliance and digital transformation. Connect with our experts and discover how we can optimize your business processes!

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Companies are seeking solutions to improve the quality, traceability, and digitalisation of their processes.

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GxpManager at Digital Enterprise Show 2024

Meet our team at booth 1G756 and discuss data strategies to ensure your company complies with the current regulations in your industry.

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