Solutions

Compliance Challenges in Life Sciences

Keeping up with constantly evolving FDA and EU regulations presents major challenges in the life sciences industry.

1

Software issues account for over 20% of medical device recalls, with poor validation causing significant financial impacts, including drops in stock value.

2

Cloud systems in life sciences are growing by more than 35% annually, and have been linked to 65% of regulatory warning letters over the past three years.

3

Traditional computer software validation methods add a minimum of 30% to project costs, and quality assurance expenses take up 12-18% of industry revenue.

Regulatory Risk & Validation

Our regulatory experts, in partnership with our AI platform, manage system and process risks related to computer software validation, AI, and IT system strategies across production, laboratory, and supply chain systems. We streamline regulatory compliance, reduce risk, and accelerate the commercialization of innovations for patients.

Commercial Compliance

We provide solutions that help to mitigate risks arising from external stakeholder engagement, supporting the continuous monitoring and application of anti-bribery and anti-corruption controls.

RiskCortex™

Revolutionize your regulatory risk management with RiskCortex™. Our AI-powered platform, combined with expert advisors, delivers unparalleled support in managing business risks related to systems and commercial compliance. We empower your team to focus on innovation, while ensuring compliance and driving growth.

How do we work?

We combine machine intelligence with decades of human expertise in regulatory quality assurance and compliance risk to cost effectively lower your businesses risk.

Risk Framework Mapping & Discovery

21 CFR Part 11 (QA/CSV)
EUAI Act (AI Act)
Cyber Sec
NIST AI / EU AI Act
HCP Engagement Code
Mapping <System/Process> risk framework

Controls, Policies & SOPS

Auto/Generate additional quality controls
Identification of monitoring controls
Auto/Generate policies & SOPs

Risk Model for Compliance

Generate <System/Process> control validation plan
Auto/Generate <System/Process> validation test scripts
Sign-off with Quality Architect (QA)

Control Validation / Testing

Auto/Run <System/Process> validation tests
Continuous QA Monitoring Plan

Lights on Validation (LoV)

Continuous & Autonomous validation & document control test results for <System/Process> changes over the lifecycle

Ready to Transform your Business?

Unlock the power of continuous & autonomous risk management driven by intelligent automation and domain experts delivering cost-effective, scalable regulatory validation & commercial compliance.

Get in touch with us today to begin your transformation!

In today’s fast-evolving life sciences landscape, efficient regulatory compliance isn’t just a requirement—it’s a competitive advantage. LifeStream DSA’s use of AI their expert advisors helped us achieve our validation goals for 21CFR Part 11 and our GAMP requirements without sacrificing speed or quality.

The use of AI and automation in delivering compliance monitoring, as achieved by LSDSA advisors, was both pragmatic and refreshing. It enables us to proactively detect and manage risks.

Quality assurance in life sciences must evolve as regulations and technology do. With LSDSA’s intelligent automation, we’re able to maintain rigorous quality standards across all touchpoints while freeing up our teams to focus on high-value tasks that drive innovation and growth.

Navigating compliance in multiple jurisdictions requires not only expertise but impressive is the way LifeStream was able to provide us a technology solution that is tailored to our process – it has kept one step ahead in our processes.