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:-
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 a satisfactory level of 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:-
If you would like to discuss how your business can benefit from AmpleLogic Pharmaceutical Quality Management System (QMS), please contact us