Governed AI and audit-ready control for GxP work
Pharma, biotech, CROs and CDMOs work across regulated quality and clinical SaaS, handle both PHI (clinical-trial data) and high-value research IP, and rely heavily on external partners on mixed devices. Mira governs the browser and the AI: PHI and proprietary fields are redacted before any model call, partner access is scoped without VPN/VDI, and every action is captured in a time-anchored, Part 11-aligned audit.
Where GxP workflows leak risk
Protocols, CSRs, deviation/CAPA records and adverse-event reports move across quality and clinical SaaS and external partners (CROs, sites, CDMOs) on mixed devices — while Part 11 demands audit trails, access controls and data integrity (ALCOA+).
PHI & research-IP exposure
Clinical-trial PHI, protocols, formulations and pre-publication research move across quality and clinical SaaS, downloads, clipboard and AI tools with no containment.
External partner access
CROs, sites and CDMOs need access to regulated systems from devices you don't manage — and CDMOs must keep multi-client data segregated.
Part 11 & data integrity
FDA 21 CFR Part 11 and ALCOA+ require audit trails, access controls and validated, attributable records — hard to prove across a browser sprawl.
Govern GxP work without slowing the science
Mira makes the browser the control point: access scoped by study and role, PHI and IP redacted before any model call, and a time-anchored audit aligned to Part 11 and ALCOA+ — across every clinical and quality SaaS tab.
- Study/role access (ABAC)Scope app and data access by study, site, role and sponsor — central locks segregate multi-client data for CDMOs.
- PHI & IP DLPClinical PHI, formulations, protocols and pre-publication research are detected and governed across downloads, uploads, clipboard and AI reads.
- Governed GxP AIReview protocols, CSRs, SOPs, deviation/CAPA and adverse-event records — with PHI and proprietary fields redacted before any provider call.
- Part 11 / ALCOA+ auditMetadata-first, time-anchored records of access and action align to 21 CFR Part 11 audit-trail and data-integrity expectations.
Capabilities for pharma & life sciences
Quality & clinical workspaces
Role-tuned workspaces across QMS, CTMS, EDC, regulatory and document systems.
PHI & research-IP DLP
Detect and contain clinical PHI, formulations and pre-publication research before they leave the managed browser.
Governed GxP AI
Summarize and extract from protocols, CSRs, SOPs and CAPA records under policy, with PHI/IP redaction.
Part 11 / ALCOA+ audit
Time-anchored, metadata-first audit aligned to 21 CFR Part 11 and data-integrity principles.
Study/role RBAC/ABAC
Access and barriers by study, site, role and sponsor — with multi-client segregation for CDMOs.
ZTNA for CROs & sites
Identity-bound access to regulated systems for CROs, sites and CDMOs — without VPN or VDI.
From protocol to adverse-event review
AI assistance and hard controls across clinical, quality and research workflows.
- Protocol & CSR reviewSummarize and compare protocols and clinical study reports with PHI and proprietary fields redacted, sources attached.
- Deviation, CAPA & adverse eventsReview deviation/CAPA and adverse-event records under policy, with a time-anchored audit trail.
- CRO / site / CDMO accessGive external partners least-privilege, audited access to regulated systems from BYOD — without VPN/VDI.
- Research-IP protectionContain formulations, pre-publication research and trade secrets across collaboration tools and AI reads.
Trusted apps for this role
Mapped to your obligations
Questions for Pharma & Life Sciences teams
How does Mira support 21 CFR Part 11 and data integrity?
Can teams use AI on clinical and quality records?
Can CROs, sites and CDMOs use Mira without VPN or VDI?
Protect PHI and research IP across every GxP tab
See Mira govern clinical PHI, research IP and every data movement across your quality and clinical SaaS — with a time-anchored audit aligned to 21 CFR Part 11.