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EzQMS Products
1. EzQMS
This is our Flag Ship Product.
This product software organizes
and enhances your ISO 9001, ISO/TS 1694(automotive),
AS9100 (aerospace), ISO 14001 (environmental), ISO 17025
(laboratory), OHSAS 18001 (health and safety), ISO 13485
(medical devices), TL9000 (telecommunications), ISO 22000/HACCP
(food) Industries, FDA, and CMDR (Health Canada).
Provides ease of use for employees / Ability to use your
current forms/templates and documents or purchased from us which are viewed in
Microsoft Viewers / Network Capability / Documentation
entered into EzQMS is part of document control thru the ECN
Process / Easy retrieval of your quality records / Email
Notification to your Corrective and Preventative Action
(CAPA), Non-Conforming Reports (NCR) & Engineering Change
Notices (ECN).
2.
EzQMS Hosting
We provide our customers a solution for
Hosting there Quality System using our Hosting site SQL Server. This is a great option for
a customer who doesn't have a SQL Server or customers who just
don't want the hassle of the maintenance and or having one and to
support it.
One important advantage of having us Host,
is you can load multiple copies on computers on your network and we
will control concurrent users using the system that you paid for.
Hosting makes it a breeze to allow for of site locations to access
your quality data.
3.
ISO 9001 System™
is
specifically designed to meet the ISO 9001 standard. Achieving ISO 9001 certification recognizes
your company as a worldwide leader in customer service...
4.
ISO 9001 + CE Marking System™
is specifically designed to meet ISO 9001 and CE Marking
standards. Achieving ISO 9001 certification recognizes your company
as a worldwide leader in customer service. CE Marking is required by
EU for products and services entering the European marketplace...
5.
FDA QSR System™
is
specifically designed to meet FDA QSR regulations 21 CFR Part 820.
Required by FDA for medical device manufacturing and servicing. Also
meets FDA’s 21 CFR Part 7 (Recalls), 21 CFR Part 803 (Medical Device
Reporting), 21 CFR Part 806 (Corrections and Removals) requirements
for medical devices...
6.
FDA QSR + Risk Analysis System™
is specifically designed to meet FDA QSR regulations 21 CFR
Part 820 , ISO 14971 standard for conducting FMEA’s. Required by FDA
for medical device manufacturing and servicing. Also meets FDA’s 21
CFR Part 7 (Recalls), 21 CFR Part 803 (Medical Device Reporting), 21
CFR Part 806 (Corrections and Removals) requirements for medical
devices. The Risk Analysis section contains Procedures and
Spreadsheets for conducting Failure Modes Effects Analysis...
7.
FDA QSR + ISO 13485 + CE Marking + CMDR System™
is specifically designed to meet FDA QSR and ISO 13485 , ISO
14971 , EN 980 , Risk Analysis , CE Marking , MDD 93/42/EEC
standards, Health Canada SOR 98/282 and Australian regulations. Also
meets FDA’s 21 CFR Part 7 (Recalls), 21 CFR Part 803 (Medical Device
Reporting), 21 CFR Part 806 (Corrections and Removals) requirements
for medical devices. CE Marking is required by EU for medical
devices entering the European marketplace. Also meets Canadian and
Australian Medical Device Regulations. Your company’s quality system
will meet FDA and International medical device manufacturing and
servicing standards...
8.
ISO 13485 + CE Marking System™
is specifically designed to
meet ISO 13485 , ISO 14971 , EN 980 , Risk Analysis , CE Marking and
MDD 93/42/EEC standards and regulations. CE Marking is required by
EU for medical devices entering the European marketplace. Also meets
Australian Medical Device Regulations. Your company’s quality system
will meet international medical device manufacturing and servicing
standards...
9.
ISO 13485 + CE Marking + CMDR System™
is specifically designed to meet ISO 13485 , ISO 14971 , EN
980 , Risk Analysis , CE Marking , and CMDR standards and
regulations. CE Marking is required by EU for medical devices
entering the European marketplace. Also meets Canadian and
Australian Medical Device Regulations. Your company’s quality system
will meet international medical device manufacturing and servicing
standards...
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