Client testimonial

Compliance with FDA 21 CFR Part 11

Leading international pharmaceutical company uses Avanteam's QMS software Quality Manager software to efficiently meet FDA 21 CFR Part 11 requirements.

The need

Control and regulatory bodies such as the FDA - Food and Drug Administration now impose draconian computer security measures to ensure the quality of products and the security of processes implemented by manufacturers.

In the pharmaceutical sector, 21 CFR Part 11 groups together the now mandatory requirements and recommendations of the FDA to ensure the authenticity, integrity and, if necessary, confidentiality of electronic records, and to guarantee that the signatory of a document cannot refute his electronic signature. This U.S.-based pharmaceutical laboratory was looking for a Quality Management System (QMS) solution that would fully comply with FDA requirements and Good Manufacturing Practices (GMP).

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The solution

Following a call for tenders, this laboratory chose in 2002 the Quality Manager software which perfectly meets the requirements of 21 CFR Part 11 thanks in particular to the following functionalities:

Secure and encrypted double electronic signatures.
Log of all changes made to records (audit-trail).
Complete history of validation or processing circuits.
Electronic safe ensuring data integrity and access security.

The return on investment

Thanks to Quality Manager this pharmaceutical laboratory has greatly simplified the management of its quality management system, while effectively meeting regulatory requirements.

Based on a centralized, unified document and business process management platform, Quality Manager supports the various information management workflows, from the early stages of R&D through to marketing authorization. This has helped the company to harmonize processes, improve collaboration between teams, ensure regulatory compliance, while reducing costs.

To go further

Given the popularity of QMSsolutions, more and more players and offers are appearing today, with different functionalities and approaches.

It is therefore important when making your choice, to take into account the following criteria:

Opt for an ergonomic, open QMS solution, capable of supporting a wide variety of processes and business rules, and easily interfacing with your existing IT systems: ERP, CRM and DBMS.
Choose QMS software that is accessible to operational staff, enabling them to easily reconfigure their processes without having to resort to heavy, costly development.
Do not forget the user interface and the ergonomics of the application. Your users should be able to use it after a one-hour training, or even a simple online training.

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