QMS

QMS – Electronic Quality Management System(eQMS)

AmpleLogic QMS or Electronic Quality Management System (eQMS) provides a holistically automated and computerized solution to organizations as opposed to paper-based techniques and functioning adequately with both units on a single platform. The system uses a web-based quality management software which allows for efficiency and transparency in production according to a set quality specification and resolves quality issues from their fundamentals.This system is very useful for organizations that manufacture drug products within a regulated environment and helps them adopt and adhere to strict stipulations set by global regulatory bodies.

CAPA - Quality Management System

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 - QMS

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 - Pharma Web QMS

Market Complaints

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

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Audit Management

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

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

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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AmpleLogic - Out of Specification

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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Out of Trend - AmpleLogic

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

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

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It is noteworthy that AmpleLogic Pharmaceutical QMS Software complies with all US FDA regulations such as 21 CFR Part 11 requirements, EU Annex 11, MHRA, GAMP, GMP, ISO, and other regulatory standards.

Importance of Quality Management in the Pharmaceutical Industry

  • Pharmaceutical manufacturers have to implement a system that ensures a product that adheres to the quality attributes that will meet the needs of healthcare professionals, patients, and regulatory authorities.
  • An effective monitoring and control system helps to maintain product quality and process
  • It can also Implement product quality and process improvements, and innovations to the pharmaceutical quality system for effective and consistent quality needs.

Features and Benefits of Quality Management Solutions

Pharma Web QMS Software
Quality Management System in the Pharmaceutical Industry

Market Oriented

  • AmpleLogic Quality Management System (QMS) is designed based on customers’ present and future requirements necessary for their success.
  • As Pharmaceutical companies are facing extraordinary pressure to adapt to changing market conditions, there is a need of Innovative management technology that can help pharmaceutical industries to gain an enormous advantage with new approaches to research and development.
  • AmpleLogic Pharmaceutical Quality Management System (QMS) Software has the ability to automate and streamline organizations and effortlessly enables the improvement of production operations ensuring high Quality of products and the Speed of delivery.
  • AmpleLogic Electronic Quality Management System (eQMS) is flexible enough to accommodate your needs So that you can easily adapt to the company’s specific requirements and changing business needs.

Employee Engagement

  • AmpleLogic QMS help you to empower your Employees with required knowledge through practical training, collaboration tools and clear channels for communicating opportunities.
  • This web based Total Quality Management System (QMS) can integrate with learning management System which Helps to oversee an array of on-the-job and research trainings.
  • Our Pharmaceutical QMS Software can work along with LMS systems to ensure that each staff member receives appropriate learning and training.
  • AmpleLogic Pharma QMS System can reduce risks of poor quality products by triggering ad-hoc training for continuous Improvement of all industry personnel.

Systematic Approach

  • Pharmaceutical companies have to maintain quality standards throughout the product life cycle.
  • This Systematic Quality Management System is essential for maintaining these quality standards and regulatory compliance in pharma
  • We work hand in hand with regulatory standards like 21 CFR Part 11 requirements, EU Annex 11, MHRA, GMP, cGMP, ISO Standards, and others to ensure that we comply with the standards set by these bodies.
  • Keeping this in mind we have developed eQMS Software which helps you to develop clear SOPs for every role in the organization.
  • For small and medium scale pharmaceutical industries who Entirely depends on outsourced manufacturing partnerships, AmpleLogic Pharma Web QMS Software helps them to set clear Standard Operating Procedures (SOP’s) for supply chain partners and maintaining transparency throughout the product life cycle.

Seamless Integration of modules

  • AmpleLogic Electronic Quality Management System is designed with a framework to govern interrelated processes.
  • This pre-configured Integrated Quality Management System (QMS) comprises of various modules including CAPA Tracking, Change Control, Market Complaints, Deviation Management, Vendor Qualification, Audit Management, OOS/OOT, Document Management and, Training Management, with powerful automation and with intelligent tracking.
  • AmpleLogic Pharma Web QMS is designed to be adjustable and can work easily with other systems such as ERP, SAP, LIMS, Legacy Systems, MES, Document Management, Training Management etc
  • In addition to these AmpleLogic QMS System gives In depth information that is easy to comprehend with attractive visuals for easy decision making.

Data driven decision making

  • Pharma industries which make their decisions based on the analysis and data evaluation are more likely to get desired results.
  • AmpleLogic Pharma QMS Software System 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.
  • Our Quality Management Solutions provide a unique central repository system which is a central location for storage and maintenance. This allows for effective documentation and database distribution.
  • AmpleLogic Pharmaceutical QMS System provides metrics reporting and analytical trends that predicts the future stock price movements.

Effective Communication

  • Effective relationships and communication are very important to coordinate the people, processes and technology. Our QMS System supports real-time, productive dialogue between management, employees and third-party organizations in the supply chain.
  • Enables effective customer service operations and ensuring clients’ relations by an opened platform for communications and information. This is done via email alerts or notifications and well-documented customer reviews and approvals.
  • This Pharma QMS are transparent and detailed and can be positioned on both on premise and cloud-based systems which can be easily interchanged.

Easy Access

  • AmpleLogic eQMS offer easy access for end users with simple search features and mobile access to real-time collaboration.
  • Our QMS Software is very user-friendly, easy to use and made to aid hectic tasks and streamline quality control.
  • AmpleLogic QMS is a web-based application, it is hosted in the cloud and on-premise system . This means that you can access it from everywhere as long as you have a device with an Internet connection.

Ongoing Development

  • For pharma companies, constant improvement is like imperative to survival.
  • The pharmaceutical industry will always be under pressure to meet strict regulatory requirements and to meet changing customer Requirements as well.
  • AmpleLogic QMS Software with its integrated features can help in providing employee training on SOPs and improvement goals. Asses employee training performance, Track and audit progress to meet quality standards.
  • Our Enterprise Quality Management Solutions (EQMS) allow organizations to meet standards while discovering new opportunities consistently based on real-time data sources such as customer reports, complaints, market research, audits, records, employee feedback and other data sources.
  • AmpleLogic Pharmaceutical Quality System is designed to be used independently or together with other modules to provide transparent and efficient workflow for creating improvement objectives

Need for Electronic QMS in Pharma 

Inter-Department Communication

  • Often, a paper-based QMS tends to increase the gap for quality system collaboration inside departments of an organization, creating quality process integration difficult. An effective eQMS Software allows you to address quality issues in different departments and makes it easier to solve those issues

Data Management

  • Industry standards and guidelines need a time-bound QMS process, including Corrective and Preventative Actions (CAPA), Complaints, Deviations, and Change management, to record the complete data from initiation to closure, and during effectiveness reviews after closure. EQMS ensures you to manage real-time data and timely closures of Quality Improvement and Quality Control processes.
  • QMS Software eliminate paper-based concerns such as duplicate or lost documents, and uncontrolled versions and also automatically track and trend metrics for management reviews.

Accessibility

  • Paper-based QMS documents have the significant drawback of restricted storage locations and limited access, which is commonly violated with no documented record of changes.
  • A sound electronic system ensures anyone with a login ID and unique password has access to view and edit quality records with increased visibility, change accountability and document traceability while maintaining utmost security.

Inspection Readiness

  • A Single Source that contains quality records along with documented evidence will help to maintain the organization at an inspection-ready state all the time. It ensures efficient record retention and retrieval process while adhering to retention policies

We have partnered with several biotechnology, pharmaceutical, life sciences, medical devices and manufacturing industries for years to meet their US FDA regulations, 21 CFR Part 11,  EU Annex 11, MHRA, GAMP, GMP, ISO standards and other quality needs.

Kindly contact us for more information about how your organization can benefit from AmpleLogic Electronic Quality Management System (eQMS)