QMS

QMS – Quality Management System

AmpleLogic Quality Management System (QMS) is a web-based quality management software that provides an end to end solution to the organizations that enables to automate or eliminate paper-based the processes and integrating them across a single platform. This will bring exceptional transparency across all the systems and in resolving your issues down their roots.

Organizations that manufacture drug products within a GxP or regulated environment are required to deliver quality consistently throughout their operational processes. So, these companies need to adopt a Quality Management Software adhering to strict regulations imposed by the FDA (Food Drug & Administration) and other global regulatory bodies.

CAPA

CAPA Management and Tracking Software is designed to fully integrate with other critical quality systems such as but not limited to Audits

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Change Control

Change Control Module is designed to maintain smooth communication and coordination in order to manage every significant step of Change

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Market Complaints

Market Complaints Management Software automates the handling of complaints from initial complaint, acknowledgment, regulatory

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Audit Management

AmpleLogic Audit Management and Scheduling Software enable the organizations to manage audit schedules, internal audits as well as external

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Deviation Management

AmpleLogic Deviation Management Software automates the manual process of handling planned and unplanned deviations from deviation reporting

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Vendor Qualification

By being a web-based platform the proposal of new vendors for qualification is easy with sections that capture complete vendor information through

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OOS

OOS Management System automates the process of handling Out-of-Specifications for raw materials or finished products from initial reporting

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OOT

OOT Management Software allows the Quality Unit of an Organization to manage OOTs, from initial reporting through failure investigations

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Lab Incident Reporting

AmpleLogic Lab Incident Reporting module is used to automate the manual paper-based process

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Due to the growing custom bucker demands in the market and to make a global presence and to stay in competitive, there is an effective need to establish the Enterprise Quality Management System to be implemented across the enterprise which is to be robust, effective and efficient.

Quality Management System in the Pharmaceutical Industry

AmpleLogic Pharmaceutical QMS Software is a pre-configured Integrated Quality Management System that comprises of 13 modules like CAPA Tracking, Change Control, Deviation Management, Market Complaints, Audit Management, OOS/OOT, Vendor Qualification, Document Management and, Training Management etc. with powerful automation and with intelligent tracking.

Our QMS system has been developed to be flexible in adapting quickly and adhering to comply with regulatory standards (ISO) and be diverse across a wide range of customers, maximizing their benefits of reducing the costs.

AmpleLogic QMS will comply with all US FDA regulations such as 21 CFR Part 11 requirements, EU Annexure, MHRA, ISO and other regulatory standards Pharmaceutical QMS Software.

Features and Benefits of Quality Management Solutions

Pharma Web QMS
Quality Management System in the Pharmaceutical Industry
  • Ensure compliance with 21 CFR Part 11 requirements, ISO Standards, and other regulatory standards
  • Our Flexible QMS Architecture will integrate seamlessly with other ERP, SAP, LIMS, Legacy Systems, MES, Document Management, Training Management, and other systems.
  • AmpleLogic QMS Pharma will improve all operational efficiency by automating and streamlining your organizations.
  • Provides configurable triggers, email alerts or notifications and reporting capabilities to Customer/ Regulatory at defined workflows steps for appropriate document reviews and approvals.
  • Our eQMS Software improves the response times for your both internal and external audits, product releases and required changes.
  • Can be accessed from anywhere from any device with 24/7 global accessibility that allows managing your issues round the clock.
  • Capable to provide metrics reporting and analytical trending that gives real life informational reports with an eye-catching visual representation to take a quick decision making.
  • AmpleLogic Quality Management Solutions will provide the central repository system for all documentation through the organization.
  • It can create customized reports, workflow processes that fit the needs of your organization or business processes.
  • Our pharmaceutical quality management system is a web-based solution that eliminates geographical dispersion constraints.
  • With best-practice workflows allows improving closure timeliness as well as reduced initiation timelines.
  • This Pharma QMS helps to reduce administrative recurring tasks with an automating workflow distribution and tracking with defined workflows.
  • It gives clear transparency with in-depth traceability across the Integrated Quality Systems through web-based access.
  • Our QMS System can be deployed on both On-Premise and Cloud-based quality management software that automates and integrate with other existing systems.
  • Enhanced capabilities of CAPA (Corrective and Preventive Action), enabling systematic approach in Investigation, Root Cause Analysis and resolution of your issues.

Quality Management System in Pharma

AmpleLogic eQMS software is a user-friendly system helps to simplify, streamline any tedious tasks and manage your quality control processes. This quality systems software has the ability to automate the tasks, cross-functional team’s collaboration, including routing all documents with proper follow-ups, and escalates necessary triggers to users for task completion, approvals or rejection cycles. This quality management system in pharma will help to reduce risks associated with manual processes, provides better internal communication between teams, reduce costs incurred by reworks, and increase the product quality.

AmpleLogic QMS is highly flexible, easy to use and centralized solution to manage your quality needs and requirements of the organization. This QMS Software is fully configurable to your company’s specific business requirements and support changes to any fields, forms, workflows, and business logic and has the ability to add any future applications to integrate with the same. We have been helping Biotechnology, Pharmaceutical, Life Sciences, and Manufacturing companies to meet their ISO standards, Compliance and Quality needs for over 9 years

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