by Emily Hill

How EQMS improves the integrity of CAD technical designs and drawings

Most medical device, engineering and advanced manufacturing organisations use computer aided design (CAD) software. 

CAD not only brings products to life, it helps organisations to collaborate, share ideas and reduce the risk of issues post-production. 

As a quality professional who is engineering a process to control technical designs, the elephant in the room is often: 

How do we control the integrity of the CAD files? 

Sure, it could be printed and passed around...

Emails will then be fired to individuals to request their changes. But what if there is an issue with the design, and you later have to find the root cause? What if there is a change request which is incorrect? Are you going to wait for your subcontractors, multi-site staff, suppliers, and even customers to receive the files by post? How much time and resource would it take to pinpoint accountability in the face of litigation?

Or you could even pay for each member of your administrative team, contractors, and leadership team to have a CAD license.

Document Manager sequencing

Many quality professionals opt to control CAD files in EQMS Document Manager. EQMS is a secure and robust tool which is compatible with CAD viewing technologies. This gives you complete confidence in the integrity of any documentation. 

Quality management software by Qualsys (1)

How it works: 3 steps

1) Latest version of the CAD design is uploaded to EQMS Document Manager.

2) Workflows / change notifications are sent to assigned users / teams who need to approved the design before it is used. Each person has access to the tool and is able to interact with and make comments on layers of the CAD design. End user licenses are free so it is ideal for complex projects which require external consultants and specialists. 

3) Design is then approved or rejected and sent back to relevant person / people to update or add their own feedback. 

All associated notes and information relating to a file is recorded. Each version of the file is maintained in the system. 

 

Benefits: 

  • Electronic signatures and audit trails promotes accountability and reduces legal risk
  • Fluid workflows
  • Save time converting large files
  • Promote cross-border working and fully utilise skills of subject matter experts such as contractors and consultants
  • Ideal for multi-site, complex projects which have a high volume of technical drawings and designs
  • Used by many organisations for product labels and packaging, design history files, new product design / machinery, technical files
  • Supports ALCOA+ data integrity principles 

 

For more information about how EQMS Document Manager is used to improve quality and compliance, download the datasheet here: https://quality.eqms.co.uk/eqms-governance-risk-compliance-software-datasheets 

GRC Software datasheets

 

Tags: ISO 13485, Document Control Procedures, ALCOA