Laboratories
Ensure the accuracy and reliability of clinical trials to make data-driven decisions.
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.
Understanding the key challenges in laboratories
We support leading laboratories through their compliance journey and help uphold the health and safety of their customers.
Key challenges:
- 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
Provide your employees with standardized procedures and protocols for various processes in the lab, ensuring that all tasks are performed consistently.
Adhere to relevant regulations and standards, ensuring that your lab remains in compliance and avoid legal or regulatory issues.
Implement secure data management and storage procedures to reduce the risk of data tampering or loss. This reduces your margins of error.
Focus on meeting customer or stakeholder requirements. By doing so, labs can build trust, satisfaction and delivering drugs to market sooner.
"Ideagen Quality Management allows us to see the entire system and find out where our controls are effective, ineffective or perhaps non-existent."
Case study
How Spire Healthcare achieved ISO 15189 accreditation with Ideagen Quality Management
Read customer success storyHow 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.
Additional resources
Take a look at our features resourcesSeven regulatory changes in life sciences and what you should do to prepare
This blog breaks down seven regulatory changes in life sciences for 2023 and what actions you should be taking to be resilient in a changing regulatory environment.
Read blogWhat is ISO 15189 and why is it important?
Discover what ISO 15189 is, why is it important and how the accreditation influences medical laboratories and their quality management systems.
Read blogWhat is ISO 17025 and why is it important?
Find out why the standard requires that labs prioritise excellent quality practices and develop a reliable quality management system to establish and demonstrate their competence.
Read blog