RSMUS.comLife sciences companies are under pressure to move faster: accelerating research, streamlining clinical operations and improving collaboration across R&D, quality, regulatory and commercial teams.
Generative AI is increasingly part of that conversation. But unlike many industries, life sciences organizations don’t get to experiment casually.
They operate in a world defined by:
- GxP expectations
- FDA and EMA inspections
- Patient privacy (HIPAA)
- Data integrity and validation
- Audit trails that must stand up years later
So the question is not “Which AI is smartest?”
It’s “Which AI fits our regulated operating model without introducing unnecessary compliance risk?”
For life sciences companies already standardized on Microsoft 365, the answer is usually straightforward: Copilot for Microsoft 365.
Extending Your Existing Environment
For organizations already running collaboration, identity and document control on Microsoft 365, Copilot is not a new platform to govern. It’s an extension of the environment already validated and inspected–same tenant, identity and access controls, document repositories, retention and legal hold mechanisms and audit and eDiscovery tooling.
Microsoft states that prompts, responses and Microsoft Graph–accessed data are not used to train foundation models, and that interactions remain within the Microsoft 365 service boundary.
For life sciences leaders, that means:
- Fewer new validation questions
- Cleaner inspection narratives
- Lower change‑control overhead
Other AI assistants may be powerful, but they introduce new systems, new boundaries and new documentation requirements.
Considering Other AI Assistants
Life sciences executives frequently hear about ChatGPT and Claude Enterprise.
Both are credible platforms with explicit “no training by default” commitments, encryption at rest and in transit, SOC 2 / ISO‑aligned controls and configurable retention in enterprise contexts.
They are often cited as benchmarks for enterprise AI maturity. However, for life sciences companies already operating on Microsoft 365, they typically represent additional platforms to validate, not simpler alternatives.
They become relevant primarily when an organization is not an M365 customer or a specific, non‑M365 workflow requires a separate AI surface.
The Controls Regulators and Inspectors Care About
1. Use of Company Data to Train Models
- Copilot for Microsoft 365
Microsoft positions Copilot so that prompts, responses and accessed data are not used to train its foundation models. - Other enterprise assistants
Similar commitments exist, but enforcement relies more heavily on contracts and platform‑specific configurations outside your collaboration environment.
The life sciences reality is that keeping AI interactions inside an already‑approved system simplifies data integrity and inspection discussions.
2. Data Boundary and System Validation
Life sciences organizations care deeply about system boundaries, change control and impact on validated processes. Copilot operates inside the same Microsoft 365 boundary already used for SOPs, quality documentation, trial documentation and regulated communications.
Other assistants operate as separate SaaS systems, which may require:
- Additional vendor qualification
- Validation documentation
- Ongoing change assessments
3. Retention, Legal Hold, and Data Integrity
Life sciences companies often must retain records for years beyond product approval to maintain post‑market surveillance and stay prepared for litigation or inspection follow‑ups.
Copilot aligns with Microsoft 365’s retention and eDiscovery model, allowing organizations to:
- Preserve prompts and outputs where required
- Apply consistent retention schedules
- Support investigations and inspections
Other platforms offer configurable retention but introduce parallel retention and discovery processes.
4. Governance and Access Control
All major enterprise AI platforms meet baseline expectations for encryption and tenant isolation.
The difference is governance inheritance:
- Copilot leverages Entra ID, Purview, sensitivity labels, and DLP already in place
- Other assistants require parallel governance, logging, and policy enforcement
The Practical Reality for Life Sciences Companies
For Microsoft‑centric life sciences organizations, Copilot’s primary advantage is operational continuity.
Copilot respects:
- Existing permissions
- Document ownership
- Sensitivity labels
- Access restrictions between R&D, Quality, Regulatory and Commercial teams
However, there’s an important reality check organizations should keep top of mind: if document permissions or classification are inconsistent today, Copilot will surface those gaps quickly.
Bottom Line
Life sciences companies don’t fail AI initiatives because the technology isn’t powerful enough.
They struggle when AI doesn’t align with regulatory reality.
For organizations already standardized on Microsoft 365, Copilot is not just an AI assistant—it’s the most natural, inspection‑defensible evolution of the digital workplace they already trust.
Other tools exist. Some are excellent.
But when the priority is speed without compromising compliance, Copilot for Microsoft 365 is usually the smartest place to begin.
Diego Rosenfeld
Diego leads RSM's technology advisory practice, focused on helping organizations build actionable IT roadmaps and navigate business transformation. Working across a broad range of industries, he brings both strategic perspective and hands-on experience to each engagement, frequently serving clients as a fractional or interim CIO. Much of Diego's current client work centers on generative AI. He has developed a considered point of view on the subject: the organizations best positioned to benefit are those that approach adoption responsibly, thoughtfully sequencing initiatives across productivity improvement and process automation rather than pursuing speed at the expense of sound judgment. He works closely with leadership teams to develop AI strategies that are practical, governed, and built to last. Diego is a strong proponent of OKR driven IT execution, applying structured objective-setting to align technology initiatives with broader business priorities. He pairs this with a focus on IT financial transparency, helping clients identify cost optimization opportunities and determine whether their technology investments are delivering measurable value. Diego enjoys writing about emerging technology and is a regular speaker at webinars and live events, connecting the dots between strategy and real-world application. Outside of work, Diego is an avid tennis and padel player, and competes on the American Backgammon Tour.
Keith DePhillips
Keith leads the Northeast managed services and national life sciences practices. He leverages over 20 years of combined industry, business, operations, and IT experience to help drive teams and ensure client expectations are being exceeded. In addition to leading successful delivery teams, Keith works closely with RSM’s life sciences clients providing strategic advisory services supporting their business goals in IT operations and support, cloud computing and bioinformatics, compliance and regulatory support (GxP, 21 CFR Part 11), cybersecurity and security awareness training, and more.
