Life sciences
Maintain quality and compliance in a complex, volatile business landscape.
Meet regulatory requirements with ease
The life sciences industry is underpinned by complex regulatory compliance structures and processes. This demands robust, auditable, defensible processes and controls to meet these essential requirements.
Ideagen supports life science professionals to adhere to FDA, MHRA and other industry regulations and standards, while mitigating quality and compliance risks.
We help stakeholders work together effectively to create and deliver key medical documentation with data security and an audit trail.
Understanding the key challenges in life sciences and medical device manufacturing
Our experience supporting life science organizations with key operational activity has given us an in-depth understanding of the common challenges.
- Compliance
- Fulfilling regulatory requirements and addressing cybersecurity risks
- Quality
- Improving service quality and effectively managing disruptions
- Global inflation
- Ensuring operational excellence to increase cost efficiency and employee productivity
- Increased collaboration
- Continuing to assure consistent quality standards and finding effective ways to work with stakeholders
The benefits of our solutions
How we can help with life sciences
Store, organize and evidence best practice with a centralized cloud-based system. An audit-trail at your fingertips with full visibility of activity.
Gain oversight of organizational processes through automated workflows and integrations with LIMS, ERP, Veeva Vault and other core business tools.
Reduce the cost of regulatory compliance by using less resource on manual processes. Resolve all non-conformances with alerts and notifications.
Expedite your drug approval process by mitigating and managing potential risks that can arise during clinical trials.
Ideagen PleaseReview gives you a perfect audit trail. I have made its acquisition a requirement at every organisation for which I’ve led medical writing.
Case study
Lexicon Pharmaceuticals save hundreds of hours by reducing document review times
Read customer success story
Case study
uniQure uses Ideagen PleaseReview to get transformational gene therapies to patients quicker
Read customer success storyVisit the CAPA 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.
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.
Additional reading
7 regulatory changes in life sciences and what you should do to prepare
This blog breaks down 7 regulatory changes in life sciences for 2023 and what actions you should be taking to be resilient in a changing regulatory environment.
Read the blog5 editing tips for medical writers
In this blog, we look at five medical writing tips that you can use to simplify your editing process and assure a high standard of quality.
Read the blogGood manufacturing practice compliance for life sciences
Everything you need to know about Good Manufacturing Practice guidelines and how the apply to life sciences.
Read the blogThe most common FDA 483 observations
Here’s a top 10 list of the most common FDA 483 observations to help you better avoid them in your own organization so you can maintain the highest standards of quality.
Read the blog