Case Study on Electronic Quality Management Solution (EQMS)

About Client:

AL Andalous is one of the market leader pharmaceutical company in Egypt with the highest growth level which serves many therapeutic areas. The company was established with 4 regional offices that serves all over Egypt.

Business Challenge: Paper based quality management system not keeping pace with company growth

Prior to its implementation of AmpleLogic, AL Andalous used a paper-based system to manage change controls, batch records, corrective/preventive actions (CAPAs), deviations, complaints and other quality processes.

AL Andalous was challenged by manual and duplicate data entry and was struggling under mountains of paper and silos of data coming from the production, research and development and other quality departments. This made it difficult to assign, manage, approve and track quality process tasks and lead to a lack of continuity between processes, poor visibility and an inability to produce the reports for various analysis.

During the audits, there are not able to produce the required documentation to the auditors, this leads to observations and compliance issues in the quality operations.

AL Andalous’s old paper-based quality system had serious drawbacks, with inefficient reporting and no standardized means of tracking, reviewing and approving the records that are assigned to the users.

They also wanted a solution that could be validated and maintained in accordance with internal Standard Operating Procedures (SOP’s), corporate policies and external standards and regulations.

Not having a coordinated QMS system caused a lack of communication between our various plants resulting in wasted time and resources.

AmpleLogic EQMS Solution Implementation

AL Andalous began its implementation of AmpleLogic Electronic Quality Management Software by adopting different modules that includes.

  • CAPA (Corrective Action and Preventive Actions)
  • Change Control
  • Market Complaints
  • Audit
  • Deviations
  • Vendor Qualification

  • With the help of AmpleLogic eQMS, AL Andalous team are easily tracking and managing all quality related processes including Change Controls, Deviations, CAPAs, Complaints, and Audits – from issue to resolution.
  • Improve efficiency, increase control, and reduce defects as a result of implementing a cohesive change control program, which integrates with other components of the quality management system.
  • This system improves the reporting and trending processes with built-in, easy-to-use search tools and integrated reporting that provides managers the critical quality information necessary to make confident GMP decisions.
  • Switching to an electronic system however, the Al Andalous employees found the implementation and transition to be quite smooth. Working with AmpleLogic’s team, all the concerns were addressed quickly, and employees soon became very comfortable with the user-friendly system

Business Benefits of Electronic Quality Management Solution

AL Andalous rolled out AmpleLogic eQMS at the manufacturing facilities in Egypt, now using the electronic quality management system, teams are able to track and manage change controls, complaints, deviations, investigations, CAPA and effectiveness checks, resulting in improved management of the organization’s overall quality metrics reporting process. The Company now has access to accurate data in a timely manner which increases the level of information sharing in a much clearer, precise format.

  • Previously manual processes were automated, eliminating the need for hardcopy and spreadsheet data recording.          
  • AmpleLogic Electronic Quality Management Solution (eQMS) allowed them to have a greater visibility of critical information for effective decision making, transparency of operational information and better collaboration throughout the organization.
  • Provides clarity and consistency for reviewers and ensures that GMP’s and company procedures are followed.
  • AL Andalous now possesses the ability to compile and manage records for easy compliance with both regulatory audits and those imposed by its own management.
  • The Company now has access to accurate data in a timely manner which increases the level of information sharing in a much clearer, precise format between the departments.
  • Able to access the application from anywhere at any time from a device

AmpleLogic Web based QMS Software to help you innovate rapidly. We improve, accelerate, and track your all your product processes across multiple locations and teams using compliant processes.

To find out how AmpleLogic Electronic Quality Management Solution can help you in automating the existing quality management processes, contact us at info@amplelogic.com for a free demo

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