Our life science solutions
Find out how our solutions support life sciences
Life sciences software and solutions for comprehensive compliance
Thriving in the life science sector
The life sciences sector faces a dynamic landscape, and organizations must adapt to thrive. Embracing change, collaboration, and strategic innovations are key.
31%
MedTech leaders aim to cut costs with digital tech investment
10-20%
profit increase
5-15%
improvement through digital & analytics adoption
73%
companies are using tech to address cybersecurity issues
Overview
Unlock the full potential of your organization by embedding quality throughout your business processes
The life sciences industry is underpinned by complex regulatory compliance structures and processes. The ability to deal with multiple disruptive social, economic, and political issues has become normal. Fulfilling regulatory requirements, addressing cybersecurity risks, improving service quality and effectively managing disruptions are key.
“Through increased competition, a shifting regulatory landscape, and growing demands from patients and health care providers, life sciences companies face significant challenges and must find ways to differentiate themselves and remain competitive.” Deloitte – 2023 Global Life Sciences Outlook
Geopolitical disruptions risk supply chains, impacting R&D and clinical trials, underscoring the need for robust, auditable processes.
Our customers
Life sciences and medical device manufacturing
Maximize quality compliance, efficiency and reliability
Our experience supporting life science organizations with key operational activity has given us an in-depth understanding of the key challenges. The need to build stronger trust with customers through comprehensive lifecycle visibility of products, avoiding audit failures and non-conformances. We support streamlining operations to achieve excellence and surpass expectations.
Helping you comply with industry regulations, accelerate your projects and take control of your workforce’s collaboration efforts. Regulatory changes and updates are expected for medical devices, clinical trials, pharmaceutical legislation and AI. Protect your organization’s sensitive data with simple to use, FedRamp authorized and ISO/IEC 27001:2013 certified solutions.
Standards and Regulations: Key Changes and Considerations
Comply with changing industry regulations, accelerate your projects and take control of your workforce’s collaboration efforts.
Protect your organization’s sensitive data with simple to use, FedRamp authorized and ISO/IEC 27001:2013 certified solutions.
21 CFR compliant document management
The United States Government Food and Drug Administration (FDA) ruling on Electronic Records and Electronic Signatures (21 CFR part 11) sets out the criteria under which the agency considers electronic records, electronic signatures, and hand-written signatures executed on electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
ISO 27001
ISO 27001 helps organizations systematically identify and manage information security risks, resulting in stronger protection for sensitive data and assets.
ISO 17025
This standard specifies the requirements for competence, impartiality, consistent operation, and overall quality in testing and calibration laboratories.
ISO 15189
An international standard that specifies the requirements for quality and competence in medical lab environments.
Capa Management Toolkit
Access the CAPA toolkit and discover in-depth ‘how to’ guides, videos, and downloadable templates that will ensure food safety issues are identified, non-conforming products are controlled, and corrective and preventative actions implemented.
Good manufacturing practice compliance for life sciences
Discover everything you need to know about safety culture, how to measure it effectively and strategies for implementing it into your organization.
Solutions
Quality
Adhere to industry standards, regulations and mitigate quality and compliance risks. Ensure products meet crucial specifications and standards, promoting overall quality control and customer satisfaction.
Document collaboration
Facilitate efficient collaboration and communication within your business. Streamline document management processes and allow teams to collaborate, share and review important documents in real-time, enhancing productivity
EHS
Build better EHS processes, mitigate safety risks and protect employees with a unified solution for reporting incidents and managing safety.
Achieving imaging excellence and ISAS accreditation
X-Ray Medical Imaging achieves ISAS accreditation with Q-Pulse at Royal Devon and Exeter. Read more.
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Cutting QMS validation time by 50% to achieve ISO 15189 certification
Royal Wolverhampton NHS trust validate their Q-Pulse software in line with ISO 15189 requirements. Find out more
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NHS Blood and Transplant: Centralizing quality management
NHS Blood and Transplant (NHSBT) benefit from an organisation-wide quality management system (QMS) and national document control system. Read more.
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Ensuring document consistency across multiple sites
National Reference laboratory achieve multi-site consistency of operational processes with Q-Pulse. Find out more.
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Improving compliance with ISO standards
Manchester Fertility Services implements Ideagen’s Q-Pulse software to help them achieve ISO 9001:2008 and CHKS accreditation. Read more.
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Ensuring compliance and streamlining operations
Ideagen’s Q-Pulse successfully delivers unified quality management for Southampton University Hospital’s Biomedical Research Facility. Learn more.
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Wales Research and Diagnostic PET Imaging Centre: Streamlining compliance and risk management for improved safety
Wales Research and Diagnostic PET imagine centre implements Q-Pulse QMS to meet industry standards. Find out more.
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Dicerna Pharmaceuticals: Enabling seamless global collaboration through enhanced security and communication
Learn more about how major Japanese pharmaceutical company, Dicerna Pharmaceuticals, found Huddle to be the ideal solution which provides enterprise-grade collaboration functionalities with robust security measures.
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Turning the page on paper-based processes
Ideagen’s Q-Pulse becomes “one stop quality management shop” for Butterworth Laboratories. Find out more.
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Imvax accelerates document reviews for faster regulatory approval
Imvax, a leader in personalized immunotherapies, needed to streamline document reviews and improve version control ahead of an FDA filing. With Ideagen PleaseReview, they accelerated the review process, helping to bring therapies to patients faster.
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