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ComplianceQuest Blogs

5 Reasons Why your enterprise must adopt an easily configurable QMS

5 Reasons Why your enterprise must adopt an easily configurable QMS

For a few years now, product management leaders have been “working backwards” to understand “specific” customer needs and building features that “address” those needs. Late Harvard Business School professor, Clayton Christensen, who is most popular for his pioneering...

The Cost of Non-compliance

The Cost of Non-compliance

As the regulatory environment gets more and more stringent for regulated industries such as medical devices, pharmaceutical, and life sciences, we hear of even leading brands being penalized on various counts - deceptive marketing, violation of books, records and...

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Case Studies

Datasheets

Audit Management Software

Audit Management Software

Audit management is becoming increasingly challenging, given the growing complexity of businesses and the number and types of audits that need to be conducted. Your browser does not seem to support iframes.Click here to read this PDF. Back to Datasheets  

Audit Management Software

Audit management is becoming increasingly challenging, given the growing complexity of
businesses and the number and types of audits that need to be conducted. For highly
regulated companies, periodic audits are necessary to comply with laws and to ensure product
safety, quality and customer satisfaction. Companies are, therefore, fast realizing that point
solutions, manual spreadsheet-based systems or antiquated systems that have not kept up
with the current consumer business or technology requirements, no longer help manage
internal audit programs. CQ comes with an audit management solution that addresses these
issues.

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Change Management Software

Change Management Software

Though companies strive for stability in their operations; changes in procedures, business
processes, and product designs are vital for continuous improvement. Moreover, regulated
and ISO certified companies are also expected to maintain detailed documentation on all
changes that are made in a change management software. Since there are numerous change
processes to manage, such as design specifications, SOPs, material changes, supplier changes,
process changes, etc., companies need to have automation tools to deploy the change in a
consistent fashion. Not only can software for change management assure compliance, but it
can also greatly enhance a company’s productivity.

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CAPA Management Software

CAPA Management Software

For any enterprise, a robust CAPA process is crucial to address systemic issues and drive continuous improvement of
your business processes. CQ CAPA management solution uses predictive analytics and intelligence to identify the
right issues to solve. Our key focus is on helping you implement effective preventive action plans to mitigate risks.
Our solution supports various methodologies like 8D, 5W-1H, and World Class Manufacturing (WCM).

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Complaint Management Software

Complaint Management Software

With CQ Complaint Management Software, we ensure companies
have comprehensive control over how customer complaints are
collected, recorded, reported, and tracked in compliance with
industry guidelines and regulations.

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Podcasts

Solving Challenges For MedTech Manufacturers During COVID 19

Solving Challenges For MedTech Manufacturers During COVID 19

This is an Enterprise Times podcast sponsored by Rootstock. We will be talking about how medtech device manufacturing organisations can solve the challenge of growing compliance requirements and increasing supply chain complexity in the wake of the pandemic crisis....

Webinars

Honing your Supplier Quality Digital Edge – Benchmark Study

Honing your Supplier Quality Digital Edge – Benchmark Study

As much as 65% of the value of a company’s products or services is derived from its suppliers – and its supply chain. Supplier quality is a critical element of a supply chain. Today, the move to digital technologies is no longer an aspiration but has become an...

FDA’s Response to COVID-19

FDA’s Response to COVID-19

Getting your device to market is easier now that the FDA opened the Emergency Use Authorization (EUA) door due to the COVID-19 pandemic. But even the most-needed device won’t get an EUA if your submission is lacking. This webinar is your EUA roadmap. Using ventilators...

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Whitepapers

A 4-Step Guide to Digitalizing Shop Floor Operations in 2021

A 4-Step Guide to Digitalizing Shop Floor Operations in 2021

The shop floor is the core of any manufacturing company. Getting your systems and processes right for each of your plants is absolutely essential. As manufacturing companies - especially medical device manufacturers - restart operations, it is paramount that quality &...

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