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.
Coverage by obligation
Requirements met with current evidence
Where obligations overlap
Share of requirements answered by the same evidence
Darker means more requirements share the same evidence.
Evidence freshness
By source, against each control’s schedule
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, ISO 27001, SOC 2, HIPAA where it applies, and GDPR, with sourced evidence and built-in CRO and supplier oversight.
- GxP systems are validated elsewhere, and the security evidence around them has no home
- CROs and CDMOs hold your 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 |
Which ones apply depends on your size, location, and activities. TruOps runs whichever you need in one place and shows where they overlap.
The challenge
Quality owns CSV and the validation packet. Security owns ISO. Nobody owns the CRO. Partners still expect a working ISMS, and privacy (GDPR, HIPAA) sits in yet another spreadsheet.
- Validated systems have validation packets that leave out the security controls around them, and security records leave out the validation.
- CRO and CDMO due diligence was a PDF at onboarding.
- ISO or SOC 2 is a side project that doesn't reuse your GxP evidence.
What you're probably using today
Quality owns validation and security owns ISO, so CROs often fall through the gap between them.
| What you use now | Where it falls short | With TruOps |
|---|---|---|
| Quality management plus a separate ISMS spreadsheet | Validated systems have validation packets that leave out the security controls around them, and security records leave out the validation. | Scope assessments to those systems. Your quality team still validates GxP systems, and TruOps keeps the security, privacy, and supplier evidence around them organized. |
| Paper questionnaires for CROs and CDMOs | Due diligence was a PDF at onboarding. | Portal assessments sized to the risk, checked against evidence, with findings that feed your register. |
| SOC 2 automation tools | Great for getting certified, with automated tests, a big framework library, and often a trust center. Maturity scoring, custom frameworks, and deeper risk or vendor work can fall outside what they cover. | Keep your automated checks. Use any framework as your anchor, map the rest with partial overlaps clearly marked, and run vendor and risk work in the same place. Start with the policies and reports you already have. |
What teams in this industry work on
Here are the programs life sciences companies run day to day, and what good looks like when an examiner, customer, or board asks.
| Use case | What good looks like |
|---|---|
| Security around validated systems | Scope assessments to GxP systems while quality keeps ownership of validation. Security keeps the controls around those systems evidenced. |
| CRO, CDMO, and lab due diligence | Portal assessments sized to the risk for partners that hold trial, manufacturing, or pharmacovigilance data |
| ISO 27001 or SOC 2 for partners | A working ISMS alongside your quality system, mapped so partner questionnaires reuse the same evidence |
| Privacy and security across borders | GDPR processors and HIPAA business associates managed together 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 helps
- Scope assessments to validated systems and track their controls separately.
- Assess CROs and suppliers through a portal with questionnaires sized to their risk.
- Map privacy and security requirements across jurisdictions to one set of controls.
How TruOps helps
- One platform
- Compliance, risk, vendor, and customer assessments share the same questionnaires, evidence, and findings.
- Pre-filled with sources
- Assessments open with answers pulled from your documents and tools, each with a source.
- Vendor portal
- Third parties answer, upload proof, and fix findings in their own portal.
- Exam-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 ones apply depends on your size, location, and activities. TruOps runs any of them in one place and shows where they overlap.
Does TruOps validate GxP systems?
TruOps doesn't do computer system validation. 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. TruOps connects to your cloud, identity, endpoint, vulnerability, and code tools. Spreadsheets, prior reports, and policies upload into the Data Room. If you're moving from a SOC 2 automation tool or an enterprise GRC suite, you bring over your frameworks, evidence, vendors, and risks.
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 risks, each linked to the file it came from, for you to review.
Related
EU data protection: records, DPIAs, processors, and breach notification.
→FrameworksISO 27001ISO/IEC 27001:2022 ISMS and the 93 Annex A controls.
→Use casesVendor risk assessmentsTier, assess, and check vendors without getting buried in questionnaires.
→IndustriesHealthcareHIPAA risk analysis, HITRUST, and a long tail of business associates.
→See it run on your own data.
Book 30 minutes with a GRC specialist. Bring a real document, like a SOC 2 report, risk register, or vendor list (redacted is fine), and we'll show TruOps AI working on it.