eQMS – is end point Enterprise Quality Management Solution specially crafted for Pharmaceutical, Life Sciences and Healthcare Industries but not limited to that. It optimizes the various quality process and reduces the risk of process failures; improve efficiency by lowering operating costs. It is industry fit solution capable to fit in small to large scale enterprise.
eQMS stands unique by having highly classified and robust multi factor authentication method of accessing the system. Configurable Workflow, Complying with USFDA, HIPPA and other global regulatory guidelines. It has three modules such as Process Control, Document Control and Training management.
NUVO Consultancy facilitates these functionality to your systems to manage all processes electronically with multifactor authentication, which provides power to establish total control over system and data. In such difficult time of COVID, such automation processes help us operate all the process as they all are cloud based and remain uninterrupted. This might also facilitate the virtual audit of your organization globally.
eQMS can serve various Health Industries:
- Medical devices
- Biologic and Biotechnology
- Life sciences
- Neutraceutical and Food Industry
Following are the highlights of the eQMS solution but not limited to the process mention below. It can be further be customized to fit your requirement.
- QUALITY PROCESSES
- Change control
- Market complaint
- OOS and OOT
- Audit management
- DOCUMENT CONTROL
- SOP management
- Controlled copy release
- ELECTRONIC TRAINING RECORDS
- Training records management
- Training management
Few insights of the process management system:
eQMS Change control is a process to manage different change requests in controlled and coordinated manner which provides checks and balances in the quality system by tracking, reviewing and approving the changes.
eQMS, change control solution triggers impact assessment and risk assessment within the change request. Impact Analysis and risk reduction helps to identify the criticality of the proposed change. And, based on the criticality of proposed change, eQMS allows quality unit to approve or reject the change proposal.
eQMS has well-designed and implemented deviation management system. In eQMS, each deviation addressed and investigated systematically, defining when and how immediate actions, corrective actions, or preventive actions have been taken to prevent recurrence.
eQMS provides efficient support for obtaining critical quality data in a timely manner and enable quick response to potential failures in compliance with 21 CFR Part 11 and EU GMP.
eQMS offers well-defined CAPA system to minimize the risk and ensure compliance with regulations. Regards to CAPA, eQMS focuses on the systematic investigation of the root causes of identified risks or problems, corrects the problems, and prevents them from recurring by taking appropriate, effective and comprehensive Corrective and/or Preventive Action.
It assesses and monitor the effectiveness of such actions, in line with Quality Risk Management Principles and ensure the closure of CAPA after successful implementation.
Appropriately handled complaints can help to retain or get more customers and ensure customer satisfaction. eQMS offers an effective complaint management system to respond faster to issues which are raised internally or externally.
eQMS speed up the complaint handling process by tracking all information pertaining to their investigation and resolve the issues by using the CAPA process. It offers a structured approach for root cause investigation. Systemic evaluation and root cause analysis will help to prevent recurring of complaints. It identifies the actions (CAPA) to correct the problem and verify the effectiveness of this action. eQMS provides an opportunity to embed learnings from complaints and failure management in future product development.
eQMS provides OOS and OOT to handle different scenario and has ability to store and retrieve related document as well as complete link with resulting outcome in terms of change control or CAPA or other quality processes.
eQMS audit management software helps industries to manage a wide range of audit related activities from planning and creating checklists to identifying non-conformance, implementing CAPA’s and reporting results.
eQMS SOP management module offers state of the art system to manage and track SOPs and manage SOP life cycle right from the authoring, review, approval and release along with distribution and retrieval and archival.
eQMS Training management module helps in keeping electronic training records in secured and easily retrievable way. It is specifically useful for those who are compliance driven and established in regulated markets especially like pharmaceuticals, Lifesciences, biotechnology and healthcare domain. Training module helps to identify training needs based on job functions, skills and knowledge require to perform specific job efficiently. It keeps track of employee performance against the job function requirements based on quantitative results of quiz and qualitative assessment of his line managers. It backed with ability to assess the recipient with randomly generated quick from a larger question bank. The quiz can also be intelligently designed from multiple eLearning modules and questions are randomly picked up so two people taking assessment quiz at the same time, or the same person taking repeat quiz, get different set of questions.
Key Benefit of eQMS
- Field level audit trail
- Industry fit and flexible workflow
- Compliant with 21 CFR PART 11 and EU GMP guidelines
- Email alerts and notification
- Equipped with dashboard functionalities
- Easily integrated with other quality process
- Color legends for easy tracking
- Comprehensive and dynamic reports with trend
- 365 integration for seamless authoring
- Globally inspected by FDAs
Who can use and get benefit from the eQMS:
- API Manufacturer
- Formulation Manufacturer
- Intermediates Manufacturers,
- Contract manufacturing units (CMO)
- Research and development centres
- Excipient Manufacturers
- Packaging Manufacturers
- Other stake holders in value chain