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Healthcare & Life Sciences Industry

Discover how ComplianceQuest helps meet the product lifecycle, quality, and safety requirements of the digital healthcare industry

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Healthcare & Life Sciences Industry

Converting Regulations into a Strategic Advantage that leads to breakthrough innovations in Highly Regulated Industries

Strategic Advantage

The life sciences industry is poised for a remarkable transformation where metrics-driven business processes and regulatory compliance (such as are FDA 21 CFR Part 11 and FDA Software Validation) are dominant factors for success. To sustain and flourish in this new environment, companies have to focus more than ever before on defining, monitoring and acting on the metrics that matter. This means managing operational risks, ensuring regulatory compliance, making quality a high priority issue and standardizing processes across the value chain, both internal and external.

An operational approach that takes into account both quality and compliance will provide organizations the capability to ensure reduced operational risks, prevent supply chain disruptions, eliminate quality failures and technology breakdowns – all while enabling them to go-to-market faster and seize new opportunities. With the situation changing significantly, so are the companies that operate within it.

In-house developed systems, stand-alone applications, and manually handled paper-based processes that manage quality and compliance at the unit level pose challenges. Such systems and processes lack a broad enterprise reach and are unable to scale effectively, while compliance costs rise, and the risk of non-compliance with FDA directives increases.

To help accomplish objectives organizations have for quality and safety management, ComplianceQuest (CQ) has designed Enterprise Quality and Safety Management System (EQMS+EHS) with a focus on quality, compliance, health and safety, collaboration & social capabilities.

Strategic Advantage

ComplianceQuest: An unmatched Life Sciences Solutions provider

Life Sciences Solutions
Life Sciences Solutions

As the industry enters a new era, life science companies face increasing compliance complexity and changing business models. With a focus on rapid business growth, managing new product launches, and synchronizing release dates with product development, companies need to ensure product safety, quality and compliance with changing regulations.

Powerful, cloud-based QHSE with total Quality and Safety Management

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Built on technology, the leading enterprise cloud platform, ComplianceQuest’s QHSE provides a complete closed-loop process integration to help your internal quality and supplier quality work in harmony and comply with various compliance needs. In addition to meeting your internal quality management needs with strong and proven supply chain quality capabilities, we help clients achieve total conformity through material compliance, collaboration, supplier on-boarding, and supplier CAPA, administered through your internal portal and supplier chain feedback.

ComplianceQuest offers a comprehensive and fully cloud-based QHSE solution that streamlines document management, accelerates problem resolution in product development and launch, enhances supplier quality oversight, facilitates laboratory issue investigation and out-of-spec results handling, and guarantees a trained workforce. The solution incorporates proven best practices, such as validated controls, audit trails, electronic signatures, customizable permissions, and robust security protocols, leading to a sustainable and effective compliance strategy.

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Regulations Addressed

Regulations Addressed

  • 21 CFR Part 606, 1271
  • 21 CFR Part 11/Annex 11
  • cGMP, cGTP, CLIA
  • GAMP5 (for validation)
  • WHO Annex 2 Part 822, 823, 840
  • Blood EU 2002/98/EC
  • Tissue EU 2004/23/EC
  • ISO 18001/45001
  • ISO 31000
  • JCAHO (Hospitals)
  • CLIA (Laboratories)
  • ISO 14001
  • ComplianceQuest is the complete integrated tool to support organizations in collecting, collating and managing all of their safety and quality information to comply with Safety Management System and Occupational Health and Safety regulations.

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