Laboratories

Ensure the accuracy and reliability of clinical trials to make data-driven decisions.

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Intro

Maintain the credibility and reputation of your laboratory

Effective quality management is the cornerstone of guaranteeing the precision and dependability of test outcomes, a matter of utmost significance in domains like healthcare, pharmaceuticals and environmental monitoring.

The consistency and accuracy of data serve as the bedrock for informed decision-making, disease diagnosis and the assurance of safety in products and environments. Strict adherence to industry standards and full compliance with ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493 is indispensable.

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Understanding the key challenges in laboratories

We support leading laboratories through their compliance journey and help uphold the health and safety of their customers.

  • Sample contamination and cross-contamination
    Preventing sample contamination or cross-contamination in sensitive experiments is essential to maintain data integrity and ensure the accuracy of results
  • Regulatory landscape
    The pharma pharma industry is highly regulated to ensure the safety and efficacy of drugs. Navigating complex and evolving regulatory frameworks is a significant challenge
  • Talent shortages
    Employee shortages can hinder drug development and innovation, increasing operational costs. It creates the risk for errors and additional delays in bringing new medication to market
  • Data management
    The increasing volume of data generated by modern labs requires effective data management and storage solutions. Protecting data integrity and ensuring accessibility is essential
  • Technological advancements
    Keeping up with rapid technological changes and integrating new equipment or software seamlessly can be a challenge for laboratories, as it often requires investment and training
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Standardization of processes

 

Provide your employees with standardized procedures and protocols for various processes in the lab, ensuring that all tasks are performed consistently.

Ensure regulatory compliance

Adhere to relevant regulations and standards, ensuring that your lab remains in compliance and avoid legal or regulatory issues.

Documentation and data integrity

Implement secure data management and storage procedures to reduce the risk of data tampering or loss. This reduces your margins of error.

Customer satisfaction

Focus on meeting customer or stakeholder requirements. By doing so, labs can build trust, satisfaction and delivering drugs to market sooner.

Industry solutions

How we can help laboratories

Quality management

Adhere to industry standards and regulations while minimizing potential risks related to quality and compliance. Ensure products consistently meet crucial specifications and standards, cultivating a quality-conscious environment to enhance customer satisfaction.

Document collaboration

Facilitate efficient document collaboration and communication within your industry. Streamline document management processes and allow teams to collaborate, share and review important clinical data securely and in real-time to bring drugs to market quicker.

FDA regulation of laboratory developed tests guide

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What is an LDT?: Laboratory developed test definition

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FDA’s final rule on LDTs and what this means for laboratories

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The pivotal role of ISO/IEC 17025 in fostering laboratory excellence

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Top management commitment to quality

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What is ISO 13485 and why is it so important?

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What is ISO 17025 and why is it important?

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Pre IND meeting FDA: your need-to-knows

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Navigating the future of lab developed tests

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FDA laboratory developed tests: unpacking FDA’s final rule t

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