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Market and Industry Insights from Quality Experts

ComplianceQuest Blogs

Minimize non-conformance in a safety valuing organization

Minimize non-conformance in a safety valuing organization

A simple two-step approach to handle non-conformities in your Safety Management System Organizations across the globe are proactively looking for ways to enhance their focus on safeguarding the health and safety of their workforce. According to a report published by...

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Case Studies

Datasheets

ComplianceQuest Clinical Trial Management

ComplianceQuest Clinical Trial Management

Accelerate clinical trial processes with a next-generation cloud-based Clinical Solution, to reduce data processing time and improve clinical study administration across the entire trial lifecycle. Back to 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. 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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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

Medical Device Cybersecurity: Don’t be Vulnerable

Medical Device Cybersecurity: Don’t be Vulnerable

Share Medical devices are becoming more interconnected leading to safer, more effective technologies enabling vulnerabilities to manifest that if exploited threaten the health and safety of patients. The need for effective cybersecurity to ensure medical device...

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Whitepapers

EUDAMED Registration: A Roadmap

EUDAMED Registration: A Roadmap

Medical device manufacturers will have to become compliant with the new requirements of EU’s MDR and IVDR, which are expected to come into effect by end of May 2021 and May 2022 respectively. One of the key aspects of the new regulations is the implementation of a...

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Gearing up for EU IVDR

Gearing up for EU IVDR

The European Commission's (EC) In Vitro Diagnostic Regulation (EU IVDR 2017/746), being effective from 26 May 2022, is a ‘legislative framework’ replacing the previous IVD directive that existed, was originally developed to address the global need for safe, reliable,...

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Webinars