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There are ample quality and compliance tools for medical device companies now, including the latest cloud-based QMS software to folders filled with policy documents, training records and audit templates.
Quality management software has numerous important advantages over manual systems. Well-designed quality management software will:
- Reduce the risk of data integrity and product quality issues
- Facilitate rapid innovation with confidence all the right information has been documented (No retrospective validation!)
- Link together information and data
- Embed quality best practice
- Enhance product quality through collaboration & visibility
- Avoid duplication of effort
- Build an incorruptible audit trail automatically
- Electronic signature assurance
Business case for quality management software in life science companies
Quality management software eliminates many time-heavy manual activities such as notification management, linking together data and producing reports.
It can be used to identify not only what the situation is, but what needs to be done to make it better.
The latest in medical device quality management software
Software like EQMS (Qualsys) gives you an integrated management system for all business processes.
Many medical device quality professionals are surprised by just how powerful the functionality within EQMS is and just how much time can be saved by using a single system for all these business processes.
You can manage the entire life cycle of the document, audits, training records, risk assessments, change, accidents, CAPA - everything you will need for regulatory audits.
And you can do all this from the comfort of your computer, even for multiple services and locations. This is a real advantage for every quality manager who has felt the pain of auditing with paper records or excel spreadsheets.
The truth is that software is a tool that can bring incredible results. But like any tool it needs to be used correctly to maximise its impact.
When it comes to software selection it is always important to have supporting evidence from a 3rd party. For medical device quality management software, you can get this evidence from case studies with people who use the software already, references and reviews.
But what do the MHRA and other regulatory bodies say?
Of course it is not the MHRA's role to review software. But during inspections, inspectors will comment when software has been pivotal in making positive impact on quality or patient safety.
The MHRA and the FDA are both encouraging industry to adopt technology.
Why do the MHRA love quality management software like this?
EQMS maps perfectly to the MHRA's ethos of using technology to automate compliance activities - so businesses can take a risk based approach to focus on quality improvement and patient safety.
For more information about how EQMS aids compliance with the MHRA and other medical device regulations, access our Business case for EQMS in life science brochure here: quality.eqms.co.uk/gxp-eqms-business-case-pdf