By Industry · Life Sciences

GRC where every system has to prove its data can be trusted

In life sciences, security is inseparable from validation. Every computerized system that touches GxP data has to be validated and provably trustworthy under FDA 21 CFR Part 11, while clinical and patient data pulls in HIPAA and GDPR, and ransomware has already reached the lab and the plant.

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The landscape

Security, validation, and data integrity as one

Life sciences answers to a layer no other industry has: computer system validation. Under FDA 21 CFR Part 11 and the GAMP 5 framework, every system in a GxP process, from MES to LIMS, CTMS, and EDMS, has to be validated, with audit trails, electronic signatures, and demonstrable data integrity. On top sit HIPAA and GDPR for patient and clinical-trial data, and ISO 27001 and SOC 2 for partners and cloud vendors.

21 CFR Part 11 GAMP 5 GxP HIPAA GDPR ISO 27001 SOC 2 NIST CSF
1997
the year FDA Part 11 first made electronic records and signatures legally binding, and ever since, every GxP system has had to prove its data is complete, accurate, and trustworthy.

Cybersecurity and compliance have converged. Attacks like WannaCry reached validated GxP systems directly, and a control such as access management now has to satisfy a validation protocol, a data-integrity expectation, and a privacy law at the same time. Regulators care as much about whether the data can be trusted as whether it was breached.

Why it is hard

Validated systems do not change easily

In a validated environment, every change is controlled and documented, which is exactly what makes security hard: patching, reconfiguring, or adding a control can trigger revalidation. Meanwhile Part 11, GxP data integrity, HIPAA, and GDPR all apply to the same systems, each with its own evidence.

Managed separately, that is validation and security run as two programs, duplicated documentation, and gaps between what is validated and what is actually secure.

How SimpleRisk fits

One control library, every obligation

SimpleRisk treats life-sciences GRC the way it should be treated: as one connected set of controls that satisfies the validators, the regulators, and the privacy laws, mapped once.

  • Map once, satisfy many. Through the Secure Controls Framework, one control maps across 21 CFR Part 11, HIPAA, GDPR, ISO 27001, and 250-plus frameworks, so you test once and satisfy many at the same time.
  • Connect security to validation. Map controls to Part 11 and data-integrity expectations, so your security program and your validated state stay in step.
  • Cover clinical and patient data. Track HIPAA and GDPR obligations against the same controls, instead of a separate program for each.
  • Prove it on demand. Define tests, run audits, and produce audit-ready evidence for an FDA inspection or a partner audit.
Compliance in SimpleRisk → Risk Management → Secure Controls Framework →

Prove your data can be trusted, from one platform

Start a free trial or book a demo, and see how SimpleRisk maps your controls across every framework a life-sciences organization has to meet.

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