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Clear, actionable intelligence for regulated industries.

Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.

1703, 2022

Remote Quality Audits for Regulated Companies Come of Age

March 17th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

This article is part one of a two-part series focused on GMP quality audit management. Although quality audits are traditionally on-site, many regulated companies have experience with [...]

303, 2022

How to Conduct Remote Supplier Quality Audits in a QMS

March 3rd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Since the Covid pandemic, regulators and notified bodies have been doing more remote audits to conduct routine inspections. In fact, it helped the FDA exceed domestic inspections in FY [...]

2402, 2022

Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs

February 24th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Internal Control Programs Technology, politics, climate, and the Coronavirus pandemic are four conditions t [...]

902, 2022

7 Benefits of Quality Risk Management in the EQMS

February 9th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Regulators and standards organizations are increasingly requiring manufacturers to incorporate a risk-based approach into their quality processes. For instance, ISO 9001, replaced prev [...]

2701, 2022

AssurX Names Kevin Tom as Director of Product Management for Life Sciences & Manufacturing Industries

January 27th, 2022|AssurX News + Success Stories, FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

Morgan Hill, CA., January 26, 2022 -- AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance software, today announced the appointment of Kevin Tom as Director [...]

2701, 2022

3 Phases of EQMS Implementation and 12 Strategies for Success

January 27th, 2022|Document Management, FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

Part 3 of a three-part quality automation blog series We live in a time of rapid advancement in technology. There’s no shortage of “smart” things, from phones and watches to virtual a [...]

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