Electronic Quality Management Software System (EQMS) is being placed into many different companies within different industries like life sciences, pharmaceuticals, biotechnology, medical devices, biopharmaceutical, manufacturing and other industries different regulatory requirements with an overarching goal of helping in achieving product quality, efficiency and optimum standards.
Here are some of the points to consider when looking for a best quality management software system
Flexibility of QMS System
Businesses may implement a quality process like CAPA (Corrective Action and Preventative Action), Change Control, Customer Complaints, Deviations, Vendor Management into their Electronic Quality Management Software and this process may look different from one organization to another even if they belong to the same industry. The ability to customize the forms, fields, workflows to adapt to the changes of the business processes in future and must ensures a smooth implementation.
It is very important that these changes to the business workflow can be easily made without the admin trainings and the users must feel very flexible enough to make these changes without the need of the vendor or software providers.
Clear traceability and Security
Depending on the industry standards that you following whether it is US FDA, MHRA, EU Annex 11, GMP, ISO and other best practices will determine the amount of traceability and security that is required. To clear any internal, external and vendor audits, you will need to produce a complete audit trail history of your document activity.
Quality Management System Software helps make this very simple. Every single change made to a document, regardless of whether it is the latest or previous version, can be tracked by a system. With configured or pre-defined workflows, you will be able to produce a precise history log of every change and every review or approval made by every document user.
Whether you are in the pharmaceutical industry, medical devices or biotech industry you need to see whether the software complies with FDA CFR Part 11 requirements.
Automated workflow processes ensure transparency, take burdens off your teams or employees and move processes forward automatically. The QMS Software offer automated quality workflow process for monitoring change control, CAPA, Product recalls and Complaints to avoid the risks of non-compliance with FDA and ISO requirements. An effective business workflows will send notifications via email alerts to remind you of upcoming assignment, pending tasks and approvals. Users can also be able to customize the kind of email notifications they receive.
Quality Driven Dashboards and Reports
Huge amounts of data is gathered from multiple spreadsheets from different departments through a quality management system and it appears to be extremely difficult to create charts, graphs and distributing the data through emails to colleagues to complete the task or even export the results to an external application in to order to prepare the reports.
The Electronic Quality Management Software enable users to generate custom reports themselves. The Electronic QMS Software lets you to obtain trends and gain insight over your quality management operations with built-in components for monitoring key processes. You should able share KPIs reports and quality reports throughout your organization for data analysis
Electronic Quality Management (EQMS) System software can cut down all the unnecessary operational expenses that a company has to bear. This means that you will not only save a time spent on paperwork but also the cost of document storage as well.
Customizable, Intuitive User Interface
The QMS System should be easy customizable and easy to use interface where users can proficiently utilize it for various quality operations. To ensure maximum usability, EQMS solution can be adjusted to fit into an organization’s business requirements or needs. Having frequent training, users can easily manage their multiple tasks from the multiple devices they are using to access EQMS modules.
AmpleLogic Pharmaceutical Quality Management System Software supports centralized and consolidated data, workflow configuration, tracking and reporting for all critical business processes affecting drug manufacturing operations across the globe. The Quality Management Software modules include:
- Change Control
- Market Complaints
- Vendor Qualification
- Product Recall
- Out of Specification (OOS)
- Out of Trend (OOT)
- Lab Incident Reporting
Contact usif you would like to explore how an integrated electronic quality management software can enhance your business process.