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

Applications / Use cases / Quality Management System for a pharmaceutical logistics company

Use case

Quality Management System for a pharmaceutical logistics company

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

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Quality Management System for a pharmaceutical logistics company - by GxpMAnager

Context of the digitalization request

Our client, a company importing, packaging, and distributing healthcare products, aims to eliminate paper and manual procedures (Word, Excel, etc.) for quality management.

In the highly regulated healthcare sector, a digitized Quality Management System (QMS) is now essential. Our client opted for the eQMS solution by GxpManager.

Challenges

  • Regulatory compliance is a priority for this life sciences company. Our client must comply with the 21 CFR Part 11 standard, which sets criteria for computerized systems (access control, electronic signatures, electronic records) to ensure data security and integrity.
  • The digital transformation of the quality system should streamline users’ daily tasks and data transfers while maintaining a high level of quality.
  • The solution should incorporate employee training tracking.
  • The solution must be scalable and adaptable to the company’s future expansions.
  • The quality system will be used by a minimum of 20 people.

The application solution

Implementation of the GxpQMS application solution will enable:

  • Management of non-conformities and complaints via CAPAs
  • Change control via out-of-production and in-production action plans
  • Training tracking
  • Management of quality documentation (with tracking of employee readings)

Native functionalities of the GxpQMS solution:

  • Audit trail: all modifications are traced to ensure data integrity
  • Electronic signature
  • Workflows: to facilitate process advancement
  • Versioning: preservation of the history of previous versions
  • Access management: to create user profiles with different levels of rights (read, write, delete, or execute)

GxpQMS

QMS by GxpManager

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Results

  • Full compliance with 21 CFR Part 11
  • Reduction of the quality team’s workload
  • Faster access to information
  • Easier information transfer
  • Better overall view of the QMS
  • Facilitated audits
  • Simplified training tracking
  • An agile solution that can be deployed on a newly acquired site by the company.

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