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Medical Device

FDA Regulation 

The Medical Device Industry as well as the whole Pharmaceutical Industry is facing ever increasing requirements for productivity improvement.  Partially due to stringent FDA regulations for electronic records and a fairly conservative approach to quality assurance these industries have tended to be left behind in productivity improvement driven by the latest information technology revolution.

PAT - Process Analytical Testing 

A new set of best practices and industry guidelines called Process Analytical Technology (PAT) is emerging.  The idea behind PAT is to introduce a new Risk Based Approach for taking traditional Quality Assurance to the next level. In this approach, advanced quality statistics as well as modern web centric IT solution architectures are necessary to enable organisations to adopt and adapt to this new paradigm.

Ascari are able to deliver the next generation Risk Based Approach solutions that are FDA CFR 21 Part 11 compliant, allow greater insight and understanding of your manufacturing processes, provide real-time or rapid feedback controls, potentially reduce development and production time and minimize risks of poor process quality and reduce regulatory concerns.

Digital Batch Records 

Digital Batch History Records can be created quickly and easily even looking like existing paper forms if required.  The advantage of a digital form is that it allows full traceability, a central repository for all the data collected on the form and powerful data analysis capabilities.

Digital forms are created using the form creation tool.  These forms can contain ANY types of data that is necessary to be collected.  Once the form has been created it is connected to the online SPC reporting engine and Analytics software.

 

Digital Batch records

 

Additional capabilities:

  • Product Quality Planning Documents and SPC Data Collection Documents are created automatically
  • Fully managed within Microsoft SharePoint document libraries
  • Digital Signatures (FDA CFR 21 Part 11 Compliant)
  • Interactive Alarms & Warnings
  • Serial / XML or SECS/GEM connections to semi-automatic measurement equipment is available for automatic filling of the digital forms


For further information please contact us to arrange a demonstration of the software's capabilities related to your organisation.
 

Medical Device News

  • Design of a Cooling Guide Catheter for Rapid Heart Cooling
    Thomas L. Merrill, Denise R. Merrill, Todd J. Nilsen, and Jennifer E. Akers<br/> Cardiovascular disease is the leading cause of death in the United States. Despite decades of care path improvements approximately 30% of heart attack victims die within 1 year after their first heart attack. Animal testing has shown that mild hypothermia, reducing tissue temperatures by 24 degrees ... [J. Med. Devices 4, 035001 (2010)] published Tue Aug 31, 2010.
  • The Relation Between the Arterial Stress and Restenosis Rate After Coronary Stenting
    Linxia Gu, Shijia Zhao, Aswini K. Muttyam, and James M. Hammel<br/> Two commercially available stents (the PalmazSchatz (PS) and S670 stents) with reported high and low restenosis rates, respectively, have been investigated in this paper. Finite element models simulating the stent, plaque, and artery interactions in 3 mm stenosed right coronary arteries were develop ... [J. Med. Devices 4, 031005 (2010)] published Tue Aug 31, 2010.
  • Using an Optical Proximity Sensor to Measure Foot Clearance During Gait: Agreement With Motion Analysis
    Andy Kerr, Danny Rafferty, Philippa Dall, Philip Smit, and Peter Barrie<br/> Foot clearance is an important measurement variable in understanding trip falls. Current methods for measuring foot clearance are limited by their inability to capture multiple steps and confinement to a laboratory. Given that variation in this parameter is considered a factor in trip falling, it's ... [J. Med. Devices 4, 031004 (2010)] published Tue Aug 31, 2010.