Implementation Case Study of AmpleLogic EQMS at Julphar
About Client: Julphar is one of the largest pharmaceutical manufacturers in the Middle East, Headquartered in Ras Al Khaimah, United Arab Emirates. The company employs more than 5,000 people and distributes its pharmaceutical products to more than 50 countries on five continents and having 16 internationally accredited facilities that produce more than a million boxes of medicine a day including tablets, syrups, suspensions, creams and injectables.
Julphar was challenged with manual and paper-based quality management processes. Everything from change control, deviations, investigations and CAPAs (Corrective and Preventive Actions), audit and complaints were paper files that were transferred from one department to the other and filed away. Furthermore, these process were often disconnected and did not support the desired level of accountability. This made it difficult to assign, manage and track quality process tasks and lead to a lack of continuity between processes, poor visibility and inability to effectively conduct proper analysis. They acknowledged that this disconnected and outdated approach to quality management posed increased regulatory compliance risk to the organization. Reports would get lost within the organization or be filed improperly, and collecting and reporting on information from various teams took considerable time and effort.
Lack of data visibility among key team members, employees were adversely impacted by the resulting email overload. Additionally, information on events and deviations did not always reach the correct individuals through email channels and had to follow up through in-person or calls.
The use of spreadsheets and departmental databases created the potential for lost records, overdue investigations, and duplicate documents, and presented the risk of not meeting compliance regulations.
In overcome these challenges faced with existing quality management process, Julphar team thought of having a electronic quality system that would standardize, and automate multiple processes throughout all entities of the business by eliminating paper and disparate solutions to address quality issues, provide visibility into their quality operations processes across the entire enterprise, and improve collaboration between different departments, offices, and regions.
The Solution – AmpleLogic EQMS Implementation
AmpleLogic team worked very closely with them to understand their overall requirement and developed electronic quality management software (EQMS) which offered a centralized platform to record, manage, monitor and improve quality processes. Julphar made the decision to implement AmpleLogic EQMS based on the product’s ability to meet its functional requirements and its capacity to provide a customizable platform that could accommodate the addition of future quality and regulatory process areas. Julphar began its implementation of AmpleLogic Electronic Quality Management Software by adopting different modules that includes
- CAPA (Corrective Action and Preventive Actions)
- Change Control
- Product Recalls
- Market Complaints
This user-friendliness system has led to increases in both their resource utilization and collaboration across multiple teams and office locations. With the help of AmpleLogic Quality Management Software (EQMS) Julphar team now automating of review, approval workflow, tracking quality events, enabling change control, performing investigation/root cause analysis, tracking corrective actions to completion, streamlining the audit process, integrating with other systems, and reducing compliance risks.
Business Benefits of Electronic Quality Management Solution
- Increased organization-wide efficiency by eliminating the paper-based system and introducing a centralized file repository.
- Standardized processes to produce consistent results and documentation
- Their quality system has enabled them to escalate issues faster, improve communications with external stakeholders, proactively deal with issues, and identify resources issues
- Enhanced visibility improved change management, auditing, CAPA management and other investigations.
- Using the web-based software, management can now easily run mandatory reports and gain access to critical decision-making information. The ability to create personalized quality dashboards encouraged a cross-collaborative environment at Julphar, eliminating errors and wasted time in aligning the multiple resources for performing the task.
- Reduces time, effort and costs associated with manual, paper-based processes
- Automatic email notifications are notified to assigned team members to know immediately whenever the task is pending or assigned to right user at right time to perform.
- The higher quality of information helped Julphar Team to gain a better view into its change request processes, identify trends or issues earlier and ensure its reporting was accurate.
If you want to learn more about our EQMS solution for overcoming challenges of paper based quality management process, Contact us for a free demo schedule