Life sciences GRC, across GxP and IT.
Pharma, biotech, and medical device companies manage validated systems, clinical and research data, and a global web of CROs and suppliers.
- 21 CFR Part 11
- GxP expectations
- GDPR and HIPAA
- ISO 27001 / SOC 2
- Assessments pre-filled, with sources
- Vendor reviews sized to risk
- Findings with recommended fixes
- Examiner- and board-ready, dated
TruOps helps life sciences companies run security, privacy, and supplier assessments across regulated and non-regulated systems, including controls that support 21 CFR Part 11 and GxP expectations, ISO 27001, SOC 2, HIPAA where it applies, and GDPR, with evidence cited and CRO and supplier oversight built in.
- GxP systems are validated elsewhere and security evidence is orphaned
- CROs and CDMOs hold trial and manufacturing data
- Partners ask for ISO 27001 or SOC 2 on top of GxP
The rules that apply
Most life sciences companies answer to several overlapping regimes at once. The common ones:
| Regime | What it asks for |
|---|---|
| 21 CFR Part 11 | Electronic records and signatures in FDA-regulated activities |
| GxP expectations | Good practice requirements for validated systems |
| GDPR and HIPAA | Privacy for trial participants and patients, where they apply |
| ISO 27001 / SOC 2 | Security assurance for partners and customers |
Exactly which apply depends on your size, location, and activities. TruOps runs whichever you need on one engine and shows where they overlap.
The actual challenge
Quality owns CSV and the validation packet. Security owns ISO. Neither owns the CRO. Partners still ask for a living ISMS, and privacy (GDPR, HIPAA) sits in a fourth spreadsheet.
- Validated systems have packets; the security controls around them are not in the packet, and vice versa.
- CRO / CDMO due diligence was a PDF at onboarding.
- ISO or SOC 2 is a side project that does not reuse GxP evidence — and TruOps will not pretend to be CSV.
Bring one real document. Watch the program get set up from it.
What you are probably using today
Quality owns validation. Security owns ISO. Neither owns the CRO. That split is the risk.
| What you use now | Where it breaks | With TruOps |
|---|---|---|
| Quality management + a separate ISMS spreadsheet | Validated systems have packets; the security controls around them are not in the packet, and vice versa. | Scope assessments to those systems. TruOps does not validate GxP systems; it keeps the security, privacy, and supplier evidence around them organized. |
| CRO / CDMO paper questionnaires | Due diligence was a PDF at onboarding. | Right-sized portal assessments, checked against evidence, with findings that can feed the register. |
| SOC 2 automation tools | They are strong at certification: automated tests, a broad framework library, and often a trust center. Maturity scoring, custom frameworks, and deep risk or vendor work can sit outside that model. | Keep the automation. Run any framework as the anchor, map the rest with partials shown as partial, and run vendor and risk on the same engine. Upload the policies and reports you already have. |
Jobs this sector actually runs
Frameworks are how outsiders name the work. These are the programs life sciences companies actually staff, and what "done" has to look like when an examiner, customer, or board asks.
| Use case | What done looks like |
|---|---|
| Security around validated systems | Scope assessments to GxP systems without pretending to be CSV. Quality keeps the packet; security keeps the controls around it evidenced. |
| CRO / CDMO / lab due diligence | Right-sized portal assessments for parties that hold trial, manufacturing, or pharmacovigilance data |
| ISO 27001 or SOC 2 for partners | A living ISMS next to the quality system, mapped so partner questionnaires reuse the same evidence |
| Cross-border privacy + security | GDPR processors and HIPAA BAs on one vendor engine when both apply |
What makes it hard
- Validated and non-validated systems need different evidence.
- CROs, CDMOs, and technology suppliers hold sensitive data.
- Operations span many jurisdictions.
How TruOps handles it
- Scope assessments to validated systems and track their controls separately.
- Assess CROs and suppliers through a portal with right-sized questionnaires.
- Map privacy and security requirements across jurisdictions to one control set.
If this is your situation
Bring the validated-system list and one CRO file. TruOps will scope security assessments around GxP without claiming to replace CSV.
How TruOps helps
- One engine
- Compliance, risk, vendor, and customer assessments share one set of questionnaires, evidence, and findings.
- Pre-filled with sources
- Assessments open with answers drawn from your documents and tools, each cited.
- Vendor portal
- Third parties answer, upload proof, and fix findings in their own space.
- Examiner-ready history
- Results saved as of their date, with every decision in one audit log.
Questions
Which compliance requirements apply to life sciences companies?
Common ones include 21 CFR Part 11, GxP expectations, GDPR and HIPAA, ISO 27001 / SOC 2. Which apply depends on your size, location, and activities; TruOps runs any of them on one engine and shows where they overlap.
Does TruOps validate GxP systems?
No. TruOps is not a computer system validation tool. It manages the security, privacy, and supplier controls around those systems and keeps their evidence organized.
Do we have to rip out the tools we already use?
No. Connectors are read-only: they observe cloud, identity, endpoint, vulnerability, and code tools; they do not change them. Spreadsheets, prior reports, and policies upload into the Data Room. If you are on a SOC 2 automation tool or an enterprise GRC suite, you migrate the program (frameworks, evidence, vendors, risks), not the business.
Can we bring our existing assessments, control lists, and vendor files?
Yes. Upload workbooks, reports, policies, and vendor exports. TruOps turns them into structured questionnaires, controls, and register entries, each cited back to the file they came from, for you to review.
Related
EU data protection: records, DPIAs, processors, and breaches.
→FrameworksISO 27001ISO/IEC 27001:2022 ISMS and the 93 Annex A controls.
→Use casesVendor risk assessmentsTier, assess, and check vendors without drowning in questionnaires.
→IndustriesHealthcareHIPAA risk analysis, HITRUST, and a long tail of business associates.
→See it run on your own data.
Thirty minutes with a GRC expert, not an SDR. Bring one real document (a SOC 2 report, a risk register, a vendor list; redacted is fine) and watch TruOps set up a live program from it, with an assessment already pre-filled.