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Enterprise wide electronic quality management system (eQMS) can be a high-value asset and is now the present situation for any organization to maintain their quality management system. The precise eQMS can offer enhancing profits for the entire organization, including consistent quality, minimized errors with improved customer satisfaction.
eQMS is an endpoint configurable solution and category of enterprise technology which is designed to care the implementation of a formal system for quality management by managing documents and processes within the organization which ensures regulatory compliance.
Organizations in highly regulated industries adopt electronic quality management system to simplify compliance, risk management, data handling, and integrated complaint management into business processes and workflows.
QEdge eQMS is an endpoint configurable solution and different quality processes can be configured on single platform. It is comprised of different solutions which in a nutshell maintain quality of any organization.
QEdge eQMS has brought impressive feature that handshaking in between all QEdge eQMS modules. Where organization can create or upload SOP in document control module and if any change request has been initiated against that SOP then system will provide list of change control raised and approved in process control module, likewise after approval of SOP in Document control module, SOP will land to training module for training purpose and after completion of training, certificate for the same shall generate and it will arrive at document control module to publish the SOP.
Apart from this, all these solutions can also be interface with any legacy/ERP system. Like to fetch products/material/batch related data from legacy/ERP/SAP.
As an organization approaches market approval, an eQMS will need to scale from pre-market capabilities such as document management, training to new features and workflows. The key to effective process integration is understanding the configuration with enterprise systems. A configured system will integrate systems and processes which is written exclusively for business, which always sounds great.
As an organization seeks out the right solution, any system evaluation should meet these core capabilities. To unlock the potential benefits of eQMS adoption, consider whether systems can offer value immediately post-implementation by fast-tracking out-of-the-box solutions. Other important considerations include the ability to integrate critical processes, flexibility, reporting, and compliance.
Process flexibility is a critical function for an eQMS at any organization, especially organizations which are scaling quickly. It offers the flexibility to scale and change as organization grows and processes improves. Unless having a strong use case for a highly customized implementation. Flexibility is a measure how effectively and quickly the system can change over time. If an organization adds new capabilities, system can be updated easily by adding new modules, requirements can be pretty much met in terms of compliance. If an organization has well-established quality processes in place, then no need to fit into a rigid software or pay for customization.
An effective electronic quality management system will meet the needs and offer flexibility to adapt business practice as per need.
Organizations must consider how to meet strict regulatory requirements for reporting, including records keeping, audit trails, and access control over data. These capabilities are critical features of eQMS system. If an organization updates any document, it is simple to retrieve prior document versions and review the edit history within the eQMS system. The system offers smart links between documents to minimize rework, such as time-consuming updates to your quality guidelines. Software will create an automated notification for individuals impacted by the SOP for required training.
To achieve a culture of quality, information needs to move seamlessly throughout the quality management system. how an eQMS provide data through your processes, create accurate reporting, and create change in operations. fully integrated, closed-loop reporting capabilities can generate real business value.
Every organization in regulated business domain needs to be ready to face an audit at any time. The time to begin thinking about compliance isn’t when organization completes the product development phase and approaching market approval. It’s during the earliest stages of business, particularly when an organization evaluating solution for an eQMS. The right solution should simplify compliance from the moment of implementation by setting a strong groundwork for Part 11-compliant eSignatures, data handling, document management, and meeting other requirements such as training.
A system which doesn’t control processes under regulatory recommendations can be an enormous risk to business, especially in competitive marketplaces. Paper-based processes can easily introduce data loss and can create a risk of non-compliance with eSignatures or missing audit data. An eQMS simplify a risk-based approach to complying with all applicable regulations in an industry by incorporating the best practices.
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