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Compliance, quality and risk: Straight talk for regulated industries

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AssurX Blog | blog.assurx.com Reviews

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Compliance, quality and risk: Straight talk for regulated industries

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1

Regulatory

http://blog.assurx.com/category/regulatory

August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. FDA Eases Up a Bit on Enforcement Gas Pedal. November 5, 2015. Michael Causey, Editor-in-Chief,. Association of Clinical Research Professionals. Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued FDA. More than half of CAPA. Improving FDA Reviews of Combination Products. November 3, 2015. Just a few short ...

2

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

http://blog.assurx.com/2015/02/09/theres-no-such-thing-as-hipaa-certification-4-myths-surrounding-hosting-providers

August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers. There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers. February 9, 2015. Ron Shoop, SVP, National Sales Manager and Strategic Alliances, Medical Web Experts. 8216;certification’ among hosting providers. To these regulations in their own business practices or in a...

3

Food

http://blog.assurx.com/category/fda-regulated/food

August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Archives for FDA Regulated. FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014. December 30, 2014. New Report Suggests the US Doesn’t. December 9, 2014. Michael Causey, Editor and Publisher, eDataIntegrityReport.com. Almost across the board, the US ranks at the bottom (“regressive”) for produce traceability programs. FSMA was signed into ...

4

SaaS & Cloud Computing

http://blog.assurx.com/category/saas-cloud-computing

August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Archives for SaaS and Cloud Computing. There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers. February 9, 2015. Ron Shoop, SVP, National Sales Manager and Strategic Alliances, Medical Web Experts. 8216;certification’ among hosting providers. Myth #1: My current or prospective hosting provider is HIPAA certified. Myth #2: My current or prospective...

5

Warning Letters/Recalls

http://blog.assurx.com/category/fda-regulated/warning-lettersrecalls

August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Archives for FDA Regulated. FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures. July 14, 2015. Michael Causey, Editor-in-Chief,. Association of Clinical Research Professionals. It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for and often finding during their visits in the first half of 2015. As minor a...

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assurx.com assurx.com

Energy & Utilities Compliance-Central Enterprise Management Software

http://www.assurx.com/industries/energy-utilities.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. 8220;PG&E was extremely impressed with the whole process and support from AssurX. They were open and honest from day one and demonstrated exactly what we were looking for.”. AssurX Delivers Compliance and Control for a Constantly Changing Energy and Utilities Landscape. WATCH THE SOLUTION VIDEO OVERVIEW.

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Supplier Quality Software

http://www.assurx.com/software-solutions/supplier-quality-management.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. 8220;AssurX has been invaluable to us. It has significantly improved communication internally and the relationships with our customers and suppliers.”. AssurX SQM Spans the Enterprise and the Product Lifecycle. Improve future designs with increased visibility into production and supplier issues. Track in-line and receiving issues, lots, oper...

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Change Control Management Software

http://www.assurx.com/software-solutions/change-control-management.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. 8220;AssurX’s ease of configurability allowed us to continue to adapt our processes and solutions to Genzyme’s increasing product portfolio, facilities and international markets.”. The AssurX Change Management solution receives any type of proposed change and efficiently manages its evaluation, planning, implementation and documentation.

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Corrective and Preventive Action (CAPA) Software

http://www.assurx.com/software-solutions/capa-corrective-action.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. 8220;AssurX…allows easy management of all CAPAs on a local level as well as knowledge exchange between management throughout the global organization.”. Manager, Global Quality Info Systems. Corrective and Preventive Action (CAPA) Software. Easily setup and manage multiple, complex CAPA workflows using industry-standard best practices. Custom...

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Partners

http://www.assurx.com/assurx-partners.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. 8220;Our relationship with AssurX allows us to provide comprehensive solutions that meet the very demanding long-term needs of medical technology manufacturers at an investment level that is affordable for growing companies.”. Director of Product Marketing. Some of the benefits of partnering with AssurX:. Exceptional joint marketing programs.

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Industry Solutions

http://www.assurx.com/software-solutions/compliance-management-software/financial-sarbanes-compliance.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. 8220;The AssurX system has significantly increased visibility, as well as productivity. And since it’s so flexible, you’re limited only by your imagination in what you can do with it.”. One Solution for Every Industry. Creates an integrated approach to compliance, quality and business operations with a si...

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Training Management Software

http://www.assurx.com/software-solutions/training-management-software.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. AssurX’s system helped us to make training easier and almost fun. I had employees stopping me in the hall to thank us for making the training process so much better. Director, GMP Quality Assurance. Flexible automated training management that keeps you in control and in compliance. Assign one or more roles directly from employee records.

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Software Solutions

http://www.assurx.com/quality-compliance-software-solutions.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. It’s just an outstanding solution that is helping us more and more each day. Transparency has improved immensely…and settling issues across various divisions is much better since Ecolab went with AssurX. Manager, Quality Operations. One Platform for Quality Management &. Request a Live Demo. Simple to deploy, configure, use and modify. Keep ...

assurx.com assurx.com

Energy & Utilities Compliance-Central Enterprise Management Software

http://www.assurx.com/software-solutions/compliance-management-software/utility-nerc-compliance-assurxone.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. 8220;PG&E was extremely impressed with the whole process and support from AssurX. They were open and honest from day one and demonstrated exactly what we were looking for.”. AssurX Delivers Compliance and Control for a Constantly Changing Energy and Utilities Landscape. WATCH THE SOLUTION VIDEO OVERVIEW.

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Careers

http://www.assurx.com/careers-assurx.htm

Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. Energy & Utilities. Food & Beverage. Brochures & Data Sheets. Webcasts & Webinars. 8220;PG&E was extremely impressed with the whole process and support from AssurX. They were open and honest from day one and demonstrated exactly what we were looking for.”. 8220;If you’re looking to manage your compliance activities, or need a corrective action management system, I would not hesitate recommending AssurX.”. Required Skills a...

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May 21, 2015. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas. Quality system surveillance inspections dropped about 3% in 2013, the FDA’s Center for Devices and… [more]. There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers. As more physicians are integrating their patient EMR with third-party patient portals, they’re looking… [more]. Quality system surveillance...

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