Case Study on the Pharmaceutical Quality Management System
How one of the Largest Pharmaceutical Company, Streamlined and Automated its “Quality Management (QMS) System”
One of the largest pharmaceutical company in India has it’s headquartered in Mumbai. This is USFDA, MHRA, EMEA, and WHO approved company involved in the manufacturing and distribution of a diverse range of pharmaceutical products, biotherapeutic drugs, and other formulation products in various countries like Europe, USA, Australia, Africa, Asia-Pacific, and other emerging markets. These facilities have received approvals from various regulatory agencies along with ISO Standards across the globe. See how they have approached and implemented AmpleLogic Pharmaceutical QMS Software at their facilities
Business Challenges with Existing Quality Management System (QMS) in Pharma
Being a part of the pharmaceutical industry has to adhere to stringent guidelines of various quality and regulatory standards like USFDA, EU Annex 11, MHRA, and WHO, etc. to ensure quality, safety, and efficiency. So, there are strictly following Good Manufacturing Practices (GMP and cGMP) defined by the FDA.
Our client needs to maintain certain quality standards and improve it with the changing needs of customers bases because the poor quality of drug products not only a leads to serious health hazards but also a waste of time and money for both government and end consumers.
Like others, our client used to rely on a manual system or it’s better to say paper-based forms and excel spreadsheets methods to record, maintain, monitor and analyze a huge amount of quality data coming across the multiple locations, regions, and teams, etc. There are some set of limitations and failed to respond to various complexities like:-
- Poor allocation and utilization of resources
- Not flexible enough to produce various customized reports and graphical representations
- Lack of integration within departments and ERP System or with other existing legacy systems
- Poor flow of information data affects the decision-making process between teams
- Error-prone, time-consuming, costly and not reliable
- Very poor documentation control
- Lack of poor visibility of Change Control, CAPA, Investigations, and deviations
- Inability to produce valuable business insights and unable to highlight pain full areas.
Solution Approach – Business Solution (Pharmaceutical QMS System)
Our domain expert team deeply their pain areas across the multiple departments of an organization and so our client decided to adopt and implement AmpleLogic – Electronic Quality Management Software specially developed to solve their compliance-related complexities.
AmpleLogic EQMS in pharma offers a unified platform for the management of various quality processes that include CAPA (Corrective and Preventive Action), Change Control, Deviation, Market Complaints, Audit Management, Vendor Qualification, OOS and OOT, etc. in a single implementation phase.
AmpleLogic Team worked very closely with us during the implementation process and conducted multiple training sessions to ensure the satisfactory level response by the employees, staff during the transition from an existing manual process to an electronic system
Business Outcome – Results after AmpleLogic EQMS Implementation
As a result, we developed a dynamic configurable Web-Based Quality Management Software(QMS) in pharma with a centralized platform to streamline, record, maintain, integrate and improve quality processes. Here are a few major benefits and results:-
- 21 CFR Part 11 Compliance requirements with electronic signatures, date and time-stamped audit trails and multi-level user authentication password protection, etc.
- Ability to manage various key quality processes with interlinking and overall control access
- 24 x 7 Accessibility and Provision for a central repository for tracking of all quality activities and tasks by Quality Control & Assurance Departments.
- Features like auto alerts, notifications, emails, and escalations helped in the elimination of long hours with the advantage of accessing real-time data, reports, trends, and pending actions
- Increase in Production due to a decrease of allocating resources and due to workflow process automation hence there is no need to chase for QA heads, Managers for reviews, approvals, and initiation of a task
- Increase Insights to access real-time data about every process to have quick decision making and with ready to produce reports and KPI’s etc.
- With the real-time information, QA teams can track the previous events with ease to apply CAPA
- Able to create user-defined customized reports and graphical outputs with available fields of electronic forms
- Seamlessly integrate with ERP like SAP, Legacy Systems and other existing systems
- Improvement in regulatory compliance – through a complete audit trail, secure access, data integrity, electronic records i.e. allows data flow between different stages of departments on a real-time basis along with capturing of electronic signatures