Life sciences

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. 

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31%

MedTech leaders aim to cut costs with digital tech investment

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up to 20%

profit increase by improving performance in digital tech

5-15%

bottom line improvement through digital & analytics adoption

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73%

companies are using tech to address cybersecurity issues

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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. 

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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

Our life science solutions

 Find out how our solutions support life sciences 

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. 

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Achieving imaging excellence and ISAS accreditation

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Cutting QMS validation time by 50% to achieve ISO 15189 certification

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Centralizing quality management for nationwide compliance and efficiency

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Ensuring document consistency across multiple sites

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Improving compliance with ISO standards

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Ensuring compliance and streamlining operations

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Wales Research and Diagnostic PET Imaging Centre: Streamlining compliance and risk management for improved safety

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Dicerna Pharmaceuticals: Enabling seamless global collaboration through enhanced security and communication

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Turning the page on paper-based processes

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Imvax accelerates document reviews for faster regulatory approval

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Robust document review system and structured content: A match made in life science excellence

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Safeguarding innovation: revolutionize document collaboration, efficiency and security in life sciences

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Five critical components to ensure clinical trial success

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Building organisational resilience in an evolving regulatory environment

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Medical writing hacks: managing feedback in document reviews

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The digital transformation of clinical trials

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Pre IND meeting FDA: your need-to-knows

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Everything you need to know about a GxP compliance checklist

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7 regulatory changes in life sciences and what you should do to prepare

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Implementing compliance management systems for laboratory ac

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Developing high-quality data: a guide for quality profession

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