Pharmaceutical Electronic QMS Software Case Study

Read how this client found its solution in AmpleLogic Quality Solutions‘ automated platform, enabling it to manage its QMS Process like CAPA, Change Control, Market Complaints, Deviation, OOS/OOT and Audit Management Activities with standardized processes and have instant visibility in a real-time. AmpleLogic offers a complete Pharmaceutical QMS Software Systems designed to automate Business Processes

Client Profile: One of the research-based, a pharmaceutical company operating in the domestic and international markets in the Global Generics, Branded Formulations, Synthetic APIs space with a market presence in 40 countries. It producing a wide range of quality, affordable medicines, and market products across multiple markets. With a presence in Asia, Europe, Middle East, Latin America and other emerging markets and making forays into the US Markets.

All the manufacturing facilities have independent Quality Control and Quality Assurance operations and functions ensuring a very high standard of Product Quality. This manufacturing facility holds US FDA, MHRA, WHO, EU GMP, TGA GMP Clearance certificate and is also accredited by countries i.e. Sudan, Ethiopia, Nigeria, and Kenya.

Business Situation

A very detailed and process-oriented organization, this has a keen eye on continuous process improvements. With a multi manufacturing site facilities had several manual processes in place, including hand-written documentation, spreadsheets and using the disparate form to manage, record, report and track events, deviations, nonconformance’s, complaints, including lab incidents and defects. These inefficiencies were impacting the company’s ability to validate end products and was threatening their compliance with FDA regulations and other industry standards

Thus, operating in a highly regulated environment, quality and compliance has been made crucial for future growth, creating a need to streamline, optimize quality process and operations, SOP’s across the organization multiple sites and divisions

To overcome these challenges, there are looking for a QMS (Quality Management System) Software to implement across the facilities which can replace their existing quality systems

Solution – Quality Management Software System

Upon recognizing that AmpleLogic QMS Software i.e. an enterprise solution for compliance, risk and quality management could deliver on the desired criteria 8x faster pace and the client knew it had found software to streamline its processes across the global network locations. They realized it would also improve efficiency, facilitate the collaboration between the departmental teams, increase productivity and thus support their growth in the future

This company leveraged AmpleLogic, the automated quality management system (QMS) platform to manage its Corrective and Preventive Actions (CAPA), change control, complaints, audits, document control, deviation activities and qualified event module implementation, was integrated to streamline preparation for regulatory audits, supplier quality management, and FDA compliance.

The automated QMS System would bring together the common needs of various departmental functional groups across the operational locations. It defined an approach to a solution that will facilitate collaboration, proper knowledge sharing, and ultimately increase efficiency among teams and productivity across the entire organization.

Features and benefits in AmpleLogic QMS Software Solution include:

• Comply FDA (21 CFR Part 11 compliance) Requirements and other industry best practices
• Easy to use, highly flexible and configurable for client’ unique business requirements
• Visibility of QMS throughout the entire organization across multi-sites and locations
• Customizable dashboards reports providing clear visibility of pending due dates by user and site levels
• Provides detailed audit trails on user actions, names, date and time of when CAPAs or incidents have been created, analyzed, implemented, modified, reviewed, verified, and closed.
• The employee can find documentation – such as procedures, processes, and instructions – quicker than with the previous paper-based system
• Enabled timely reporting submissions from all plant facilities
• Create and Generate reports and export data to track trends, measure improvements, and analyze your corrective and preventive (CAPA)
• Automated reminders and email notification make workloads easier to manage
• QMS Module can be integrated with other management or legacy systems and lowering operational costs
• Greater visibility and control of organizational and business-critical documentation
• Complete management of audits with actions and reviews associated with the audit process clear at all times

With AmpleLogic cost-effective, value-added solution, the client is successfully meeting its objectives for harmonizing/standardizing multiple sites worldwide, thereby reducing risk, ensuring compliance with current industry regulations, strengthening the overall quality and customer satisfaction

To see more information, visit www.amplelogic.com and for a scheduled demo on Pharmaceutical Quality Management System (QMS Software)