AssurX offers experienced compliance administration capabilities with intensive audit trails, stability controls and Digital signature/information performance that satisfy or exceeds demanding regulatory requirements. The program is even adaptable ample to maintain you in compliance with switching cGXP specifications.
A point out of control and proof of compliance is taken care of constantly in one central, securely available process. The AssurX software is validated and comes along with IQ/OQ validation templates. Each pre-configured Answer comes with a PQ depending on market greatest tactics and the most up-to-date regulatory pointers.
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Too many companies hope that when an exterior auditor is analyzing their business enterprise they don’t uncover any difficulties.
Shielding your individuals and having your medical devices to current market starts off with a powerful good quality and compliance administration system. Our software and solutions tutorial you through the total process, guaranteeing there is a greatest-observe program which satisfies quite possibly the most rigorous compliance needs.
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Furthermore, the FDA look here needs contract companies of concluded medical devices to sign up While using the FDA, Therefore the FDA may perhaps inspect your subcontractor and you'd like to ensure you know that is More Info going on.
To be sure ongoing compliance with high quality technique procedures, you must Appraise your pre-production QMS making use of inside audits a minimum of yearly.
UL has procedures set up to determine and handle any likely conflicts of desire and maintain impartiality. Read more details on this.
Learn more about UMT next Audit All types of audits and inspections may be programmed for data assortment with a cellular unit and despatched to quick custom made reports. Find out more about UMT Audit
Our software is very configurable, so companies can plug of their present procedures & specify the info they want to gather--after which you can make updates when matters alter. ARMATURE makes top quality and compliance much easier than in the past! Learn more about ARMATURE ARMATURE builds intuitive & configurable high quality administration software for brands and corporations that measure high quality. Find out more about ARMATURE
Learn more about RealityCharting A visual Software that helps people today figure out lead to and influence interactions and utilize effective alternatives to stop challenge recurrence. Find out more about RealityCharting
EQMS by Qualsys
“We felt AssurX’s relieve of configurability authorized us to continue to adapt our procedures and answers to Genzyme’s growing product portfolio, services and international markets.”