Complex medical device risk and quality management obligations are challenging for organizations and must be observed on a daily basis and down to the affiliate level or high fines caused by noncompliance can hurt the bottom line and damage corporate market positions.
We are proud to announce our medical quality and compliance software, to be installed in your secure Office 365 environment. BPAMedical365 includes the main modules of our quality and risk management software plus additional modules for product lifecycle management.
BPA Medical Compliance software modules.
Built on SharePoint and Office 365, the software includes technologies to comply with GxP and regulatory requirements like FDA 21 CFR Part 11, MDR and ISO 13485. Additionally, BPA has developed an electronic signature module and prebuilt automated workflows to simplify your compliance journey.
BPAMedical365 can be used on any device with you favorite Microsoft tools, like Teams or SharePoint. With Teams, users have a single point of access to their medical quality system, instant discussions and video conferencing, boosting productivity.
Go a step further and reach Industry 4.0 objectives by using our Power Apps for incident registration, failure catalogue, audits and inspections.
We provide an ISO 13485 documentation kit, including a software validation quick start package, containing document templates to setup an ISO 13485 compliant system, ready to be imported in the software.