Equipment Management
Peace of mind with smart Equipment Management
For Medical Device Manufacturers, Equipment used in manufacturing and development have significant impact on the quality of final device, and consequently also on the patient safety.
With your Equipment under close supervision, you add another layer of device quality, production reliability and, ultimately, safety to users of the device.
By planning ahead, you can prevent equipment failures and reduce potential disruptions.
Track tools and equipment with full visibility with status at a glance. Know the state of every piece of equipment with a complete maintenance and calibration history, including its connections to past quality events.
Reliability through re-occurring Equipment Control
Use equipment only when approved and prevent misuse by blocking expired or uncalibrated tools.
Plan, assign, execute, follow up and sign-off on equipment calibration and maintenance activities.
Keep a complete and consistent audit trail of Equipment Control activities.
Genuine Voices, Tangible Results
Genuine Voices, Tangible Results
Aligned Elements not only surpassed all other options but also inspired us, with their expertise and commitment, assuring them of the project’s feasibility.
Stephan Ullmann
I can sincerely recommend Aligned Elements to any Medical Device company looking for a single tool to manage requirements, specifications, risks and design reviews.
Victor Steinacher
Amazing to see how adaptable AE is to our development process and risk management process, giving us the ability to work swiftly without any unnecessary constraints!
Jaimin Patel
Aligned Element have made life easy working with requirement/verification including traceability. We could easily make a structure suitable for us, for all our different products and their specifications.
Anna Norlander
Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.
Christoph Karthaus
We benefitted by being able to create risk analyses for various product groups quite quickly and easily. We could now focus more on the content, and leave the form to the system.
Andrea Paulus
The configuration possibilities offered vast benefits. We have a very large freedom in configuring Aligned Elements according to our processes.
Sebastian Reiter
The flexibility of the Aligned eQMS system has been a real game changer for us. Aligned Elements has significantly improved how we manage quality and design documentation.
Malena Costa
Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.
Claes Nilsson
We have even integrated our automated test results in our system, and by leveraging that automated data in our traceability we can be even more efficient.