USE CASE

IMPROVE REAL-TIME REPORTING AND QUALITY OVERSIGHT

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Brief Introduction

Target Group: Emerging Biotech Companies

arivis Solution: arivis5D Quality Suite

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An innovative emerging Biotech company with a strong passion for improving processes and streamlining electronics had the opportunity to become one of the first customers on the arivis5D Platform – moving from paper and spreadsheet-based quality processes to a fully integrated and electronic Quality Management System.

Expectation

The expectations from the arivis5D Platform were:

  • Transition from paper and spreadsheet-based quality processes to a fully integrated and electronic Quality Management System.
  • Implementation of a full Quality Suite of CAPA, Audits, Change Control, Deviations, Complaints, Quality Documents, and Training.
  • Better companywide staff efficiency and compliance with proper procedures by configuring an easy-to-use system with the end-user’s needs in mind.
  • Less reliance on spreadsheets by creating intuitive and automated quality processes all within a validated, compliant QMS solution

Strategy and Implementation

arivis has implemented Deviations, CAPAs, and Complaints on behalf of the client with a small, experienced team of two leading the implementation. With the small team, the implementation process moved forward quickly and both parties experienced positive progress with the project. This enabled quick decision making, innovative thinking, and rapid movement in the implementation. While working with a small team is not common for such a challenging project, the client’s team was always inclusive and involved the entire company in:

  • Gathering user requirements from other departments as needed
  • Periodic internal demos to showcase project progress

arivis has implemented Deviations, CAPAs, and Complaints on behalf of the client with a small, experienced team of two leading the implementation. With the small team, the implementation process moved forward quickly and both parties experienced positive progress with the project. This enabled quick decision making, innovative thinking, and rapid movement in the implementation. While working with a small team is not common for such a challenging project, the client’s team was always inclusive and involved the entire company in:

  • Gathering user requirements from other departments as needed
  • Periodic internal demos to showcase project progress

Result

arivis successfully met all the criteria: The migration of the manual CAPA process into arivis5D was successful. This increased user compliance, quality, and management oversight, and facilitated the management of the process. What’s more, Complaints and Deviations are now fully electronically tracked, and metrics are easy to retrieve.

Both companies are already planning the next steps of future implementation: the Training module, SOPs, Quality Forms, and Change Control are set to go live with the Audit module in the configuration.

With this project, the client went from several sources of information (spreadsheets, file sharing, legacy systems, etc.) to a unified, validated, secured, and easily accessible Quality Management System.

arivis successfully met all the criteria: The migration of the manual CAPA process into arivis5D was successful. This increased user compliance, quality, and management oversight, and facilitated the management of the process. What’s more, Complaints and Deviations are now fully electronically tracked, and metrics are easy to retrieve.

Both companies are already planning the next steps of future implementation: the Training module, SOPs, Quality Forms, and Change Control are set to go live with the Audit module in the configuration.

With this project, the client went from several sources of information (spreadsheets, file sharing, legacy systems, etc.) to a unified, validated, secured, and easily accessible Quality Management System.

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Suggest update to: For further information please contact us, we look forward to hearing from you.

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