Deploy stronger authentication
Applied rSecureKey MFA across 55 protected accounts.
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Biotechnology · rSecureKey MFA, IAM, PAM, Team Access & SIEM Evidence
Ready for the People Who Ask Hard Questions
A biotechnology company secured research access, addressed the identity-control clauses in its 21 CFR Part 11 gap assessment and turned access evidence into a prepared answer for auditors, partners and investors.
55
accounts secured with multidimensional MFA
8
team accounts converted to named access
11
privileged accounts brought under PAM
THE CHALLENGE
Why a stronger solution was needed
The company had scientific value to protect but lacked an access-control model it could confidently present to regulators, prospective partners or investors. Regulated systems had Part 11 identity gaps, shared functions relied on shared credentials, administrative rights remained standing, and access activity was not producing usable evidence.
RAINBOW SECURE APPROACH
How the engagement was structured
Rainbow Secure deployed rSecureKey MFA across 55 accounts, established role-scoped IAM and recurring access review, brought 11 privileged accounts under PAM, converted 8 shared team accounts to named Team Access and exported authentication and access activity to the company’s existing Microsoft Sentinel environment.
Why the customer selected this approach
The engagement connected identity security to three business-critical reviews: regulatory inspection, partner vendor-security assessment and investor technical diligence. It also drew a clear line between the identity clauses addressed by Rainbow Secure and the validation, signature and record controls that remained with the company.
From problem to governed access
Scope access by role
Established IAM entitlements and recurring review instead of accumulated access.
Govern privileged identities
Moved 11 accounts from standing privilege to controlled PAM.
End shared identification
Converted 8 team accounts to individually authenticated Team Access.
Send activity to the existing SIEM
Exported authentication and access evidence to Microsoft Sentinel.
Map the Part 11 boundary
Documented which identity clauses were addressed and which controls remained with validated systems and SOPs.
What was used, where and why
Rainbow Secure capability
Where it was used
How it helped
rSecureKey multidimensional MFA
55 workforce and regulated-system accounts
Added multidimensional human verification so a stolen or reused credential could not complete the protected sign-in by itself.
Role-scoped IAM
Access to regulated systems and research information
Granted access by approved role and placed entitlements on a recurring review cycle.
Privileged Access Management
11 administrative and privileged accounts
Replaced unmanaged standing administrative rights with controlled, accountable access.
Team Access
8 shared functional accounts
Converted shared credentials to named people authenticating individually, supporting unique identification and individual removal.
Microsoft Sentinel export
Authentication, refused attempts, privileged use and entitlement changes
Made identity activity retained, searchable and available alongside the company’s other security signals.
The business impact behind the technology
Research data and assay results
A dataset that leaves cannot be recovered or made secret again.
Candidate compounds and process knowledge
Loss could give a competitor a head start funded by the company’s research.
Pre-publication and pre-patent material
Disclosure can affect commercial advantage and patentability.
Regulated electronic records
Weak identity controls can create data-integrity findings and remediation work.
Partner and investor confidence
Security-review findings can delay collaboration, diligence and financing.
Risk connected to control
Threat or weakness
Control that addressed it
Stolen or reused credentials
rSecureKey multidimensional MFA
Shared functional credentials
Named Team Access for 8 accounts
Standing administrative privilege
PAM for 11 privileged accounts
Role accumulation over time
Role-scoped IAM and recurring recertification
No evidence of attempted misuse
Authentication activity exported to Microsoft Sentinel
Overstated compliance claims
Explicit boundary between identity controls and company-owned Part 11 obligations
BUSINESS OUTCOME
What changed
The client audit passed and the 21 CFR Part 11 gap assessment was signed off with the identity-control clauses addressed and the remaining system and procedural scope clearly assigned. Fifty-five accounts received multidimensional MFA, eight shared logins became named Team Access, eleven privileged accounts came under PAM and access evidence became searchable in Microsoft Sentinel.
Verified results from the supplied Biotechnology Company case study. Rainbow Secure addressed identity-related controls; system validation, in-application audit trails, electronic-signature controls and certification remain the company’s responsibility.Start with one customer problem and build the right identity-security path.
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