EQMS – Quality Management Software

The most crucial component of Pharma Manufacturing Operations is QMS

Usually, this is performed manually by a key individual in the company, and the absence or neglect of this person influences the audit quality. Automation, thus, being a superior alternative, enhances efficiency and offers a better outcome on data integrity.

Our Enterprise Quality Management Solution is a COTS system that facilitates compliance and automates the whole process. There are quality criteria for the program, which provides for maximum control and transparency. The software also addresses quality concerns at their source, allowing pharmaceutical businesses to adapt and comply strictly with the rigorous requirements imposed by worldwide regulatory authorities. For example, the US Food and Drug Administration, the MHRA, and the WHO

CAPA Tracking, Change Control, Market Complaints, Deviation management, vendor qualification, audit management, OOS/OOT, document management, and training management alongside powerful automation with intelligent tracking are some of the modules found in the pre-configured Integrated Quality Management System (QMS)

Enterprise Quality Management Software(EQMS) system minimizes the chances of quality process failures, lowers the total cost, and improves organizational compliance.

Despite these benefits, are Life sciences companies ready to make an immediate shift from manual to automated processes?

AmpleLogic has created a low code-based eQMS software based on input from pharma businesses on their automation problems as well as their work cultures. This solution provides users with a comprehensive perspective of the quality management process. With highly flexible processes, organizations may now easily control and comply with the most stringent quality requirements (such as 21 CFR Part 11, EU ANNEX 11, and cGMP).

Due to AmpleLogic’s LOW CODE Platform, organizations may experience a seamless connection between modules, reduced rework, address data reliability, and Security with 21 CFR Part 11 and other GMP compliance standards.

Features of Pharma Quality Management (QMS) Software

• For each Quality metric, such as deviations, change control, CAPA, audit management, BOM releases and specifications, stability research activities, market complaints, and real-time achievement, AmpleLogic’s Total Quality Management System (TQM) software shows dashboards. The software is automated to provide a complete solution to access, record, and generate each function’s activity. However, there is the option to carry out these processes manually.
• It is a web-based application that is available 24 hours a day, seven days a week, with access to a very safe centralized database and end-user access.
• Improved process management and business communication with fewer user mistakes and no reliance on individuals
• With automatic and programmed preemptive alerts, prompts, and escalations, you can ensure prompt authorization and closure.
• All QMS procedures are initiated, approved, assessed, and verified online, using an electronic signature and an activity stamp.
• Individual filtering options are available on a built-in notebook of the QMS electronic records.
• It keeps track of workflows, processes, modules, and admin-level operations and records them in detail.
• Communication with customers and regulatory authorities is simple and straightforward because of the built-in emailing feature.
• Allows for simple monitoring of unit/department productivity and efficiency status through the use of KPI-driven evaluation metrics and traceability trends. This provides up-to-date graphical details such as pending work, work done, personnel responsible, and timelines in an appealing visual format.
• An adaptable workflow, compliant with 21 CFR Part 11 and tailored to the customer’s procedure, is one of its key characteristics. Customizations might be made to the existing technique.
• This Pharma Web QMS Software provides configurable triggers, email alerts or notifications and reporting capabilities to customer/ regulatory bodies at defined workflows steps for appropriate document reviews and approvals
• Its adaptable QMS Architecture interacts easily with other systems such as ERP, SAP, LIMS, Legacy Systems, electronic batch record (MES), Document Management (DMS), Training Management (LMS), and others.
• When it comes to internal and external audits, product releases, and needed modifications, the AmpleLogic Digital Quality Management System (eQMS) Software increases the response time.
• It can provide statistics, record and analyze trends, and provide real-time informational reports utilizing an appealing visual representation that enables rapid decision making.
• Because it is a web-based solution, geographical that restricts distribution is eliminated.
• The Pharma QMS System Software reduces repeated administrative work by automating workflow allocation and monitoring established procedures.
• Through web-based access, the system provides openness and detailed traceability throughout the Integrated Quality Systems.
• Its increased CAPA (Corrective and Preventive Action) capabilities provides a methodical approach to inquiry, process mapping, and problem management. It can also analyze the efficiency of CAPA.

Benefits of Enterprise QMS Software in Life sciences, Pharmaceuticals, CDMOs & Biotech Industries

• In Life Sciences organizations, an efficient LOW-CODE Quality Management Software helps you to keep track of quality concerns across departments and makes it easy for you to address them. Duplicated or missing documents, as well as unregulated versions, are all eliminated by the eQMS Software.
• It provides a centralized repository for quality records as well as recorded proof. This helps to keep the organization ready for assessment at all times. It also guarantees that records are retained and retrieved efficiently while conforming to retention regulations.
• AmpleLogic Pharmaceutical QMS Software with its advanced capabilities provides data from different sources to help the quality unit and management identify a root cause among SOP changes and suggest immediate changes necessary to maintain product quality.
• The Digital QMS Software offers quality metrics analysis and analytic patterns that are guided by KPIs
• Because the business process is automated via customizable procedures, manual work is reduced.
• The Pharmaceutical Quality Management Software fully digitizes and consolidates formerly paper-based processes and documentation, enabling continuous improvement of quality or compliance processes.
• The low code-driven development reduces the expenses of modification and approval.
• When combined with Learning Management Systems (LMS), this Life Sciences and Pharma QMS System helps ensure that each staff member receives the necessary education and training.
• It shortens problem resolution times and boosts executive awareness.

The AmpleLogic Digital QMS satisfies the electronic record standards of the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Our On-Premise and Cloud-Based Quality Management Software can also be used in the following fields:

• Biologics
• Medical Devices
• Contract Development and Manufacturing Organization (CDMO)
• Chemical Industry
• Contract Manufacturing
• Generics
• General Manufacturing
• Contract Research Organization (CRO)
• Food & Beverages

The AmpleLogic Electronic Quality Management System (EQMS) may help your company in a variety of ways. Please contact us for more details