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Healthcare industry
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Tools for healthcare industry

Novagem Solutions realizes services and applications that support the biomedcial industry. Specifically for what concern the medical devices validation, it identifies, designs and develops software systems that help the partial or total automation of the product test.

 

More and more successes confirmed our customers the advantages in relying on this kind of solutions. They in fact allow to:

  • Identify malfunctions and anomalies of the device under test in real-time
  • Acquire and register data persistently for each device and then execute in a second moment tests that would take too much time to be executed during the acquisition
  • Have a single TEST REPORT that contains a complete list of all the measures taken during the test
  • Have a rich data archive, useful also for future investigations and for future purposes that may not be claer when the test is executed

Typically a similar approach to the test method leads to:
  • An immediate cost reduction ,in terms of time, up to 80%
  • The chance to use human resources without a certain specialization regarding the test execution, because most competences are required only for the one who create the test
  • Human error chance reduction, at least by 90%
  • Signficant increase of precision and punctuality of mesuraments
 

Novagem Solutions, besides provides the opportune documentation for Verification and Validation, provides to its Cutomers systems that meet the standard of the FDA Part-11.

In all the phases of the project (design, development and validation), Novagem Solutions follows a specific path, with great care to the creation of the necessary documentation. In the first phase, it is written a TRS (Technical Requirements Specification), which helps to define a better problem comprehension. The second document is a Risk Analysis, which treats every aspect of solution feasibility in terms of security, sturdiness and fidelity of data. It is also really important to take care of things like the future scalability and the interfacing with standard systems and protocols.The next phase after the realization of the solution is the production of the Design Document, which declares how the subsystems have been addressed and implemented. Then there is the design of debug test protocols to verify the systems, also called Test Design phase. When the software is ready it is “frozen” and labeled with a specific internal release and then the Test Execution phase can occur. Last the Traceability Matrix is produced, which cover the entire path of verification and validazion.

 


 

The security and the traceability that imbue the biomedical market require an increasingly number of solution Part-11 compliant.

Part-11 identifies a series of guidelines for electronic data acquisition, storaging and handling, defined inside the Code of Federeal Regulations, wrote by the FDA (Food and Drug Administration).

Following the Part-11 criterias and provisions it is certified that electronic data will have the same value of papery ones. Data management processes are certified, starting from creation, to editing, storaging, data recovery and transmission. Corporations that offer products or services in the fields of food, medicine, pharmaceutical, biotechnology, biological research, biotech, healthcare and cosmetics need to respect those rules. Audit trail certifies the revision of a program, but also of data, allowing the management and the track keeping of historical transation concerning it. Each step of a process or a data is identified, since its creation to its completion, tracking every change made and providing the chance to do a roll back.
  
 • Biomedical Data Menagment, Verification and Validation
 • Performance verification for software and hardware systems
 • Process optimization and human error reduction
 • Part-11 compliant
 • Audit trail