Built by PJ Zonis · SideGuy Solutions
Operator-honest, North County San Diego. No retainer, no sales call — a real human who'll tell you straight which of this you actually need.
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SOC 2, 21 CFR Part 11, GxP, HIPAA — four different worlds, and which ones apply depends entirely on what your company does. Here's the honest map for the San Diego life-sciences hub, no consultant bloat.
Selling software/data to pharma or healthcare? → SOC 2 (their questionnaires demand it).
In the regulated drug/device lifecycle (trials, labs, manufacturing)? → 21 CFR Part 11 + GxP/CSV (FDA, non-negotiable for regulated systems).
Handling identifiable patient data (PHI)? → HIPAA (+ BAAs with every vendor).
Most San Diego biotechs need some combination — and the controls overlap heavily, so doing one builds most of the next. Sequence by what's actually blocking a deal or required by the FDA.
Four (sometimes five) regimes — what each is, who it's for, and the trigger.
| Framework | What it is | Trigger — you need it if… |
|---|---|---|
| SOC 2 | Commercial trust attestation (AICPA Trust Services Criteria). | You sell software/data services and a customer's security questionnaire asks for it. |
| 21 CFR Part 11 | FDA rule for electronic records & e-signatures in regulated activities. | A computer system creates/stores records the FDA can inspect (eTMF, LIMS, eQMS, MES). |
| GxP (GLP/GCP/GMP) | FDA/EMA quality framework for labs, trials, manufacturing — requires Computer System Validation (CSV) + data integrity (ALCOA+). | You run regulated research, clinical trials, or manufacturing. |
| HIPAA | US law protecting identifiable patient health information (PHI). | You handle PHI — digital health, diagnostics returning patient results, clinical data tied to identities. |
| ISO 27001 | International information-security certification. | You sell to EU/global pharma partners who expect a certificate, not a US attestation. |
| Control overlap | Access control, audit trails, encryption, change management, and validation feed SOC 2, Part 11, and HIPAA alike. Build the controls once; map them to each regime. That overlap is what makes "do one, then add the next" the efficient path. | |
What we'd tell a San Diego biotech founder who asks "what do I actually need?"
Don't buy frameworks you don't need, and don't skip the one the FDA requires. The two expensive mistakes we see in the San Diego life-sciences scene are opposite: a software-first biotech over-investing in GxP/CSV it doesn't need yet, or a regulated drug-dev company treating 21 CFR Part 11 as optional until an FDA audit finds gaps. Map your reality first — are you selling a product, or running regulated science, or touching patient data? — and let that pick the framework.
If you're a life-sciences SaaS selling into pharma → start with SOC 2. That's what unblocks the enterprise deal that's stalled on a security review. Add 21 CFR Part 11 controls only when your software actually stores or modifies GxP-regulated records — at which point your SOC 2 access/audit/change-management evidence already covers most of the Part 11 technical requirements.
If you're in the regulated drug/device lifecycle → 21 CFR Part 11 + GxP/CSV are the hard requirement, not a sales tool. Validate the systems, build the audit trails and e-signature controls, and document the data integrity (ALCOA+). SOC 2 becomes a nice-to-have for any commercial-facing product layer on top.
If you handle PHI → HIPAA is the floor, and the practical work is getting a signed BAA from every vendor that touches it (see which vendors sign a HIPAA BAA) plus a real risk assessment. Don't assume "HIPAA-eligible" cloud equals compliant — configuration is yours.
The throughline: the controls overlap, so sequence by the nearest real requirement and reuse the evidence outward. If you want a straight read on which regimes your specific company triggers — and which you can safely defer — text PJ. Real answer, no consultant retainer.
Match your model to the stack.
Selling to pharma/biotech enterprises. SOC 2 unblocks deals; add Part 11 controls if your software touches regulated records.
Regulated systems (eTMF, LIMS, eQMS) must be validated with audit trails + compliant e-signatures. The FDA path, non-optional.
Identifiable patient data = HIPAA floor (BAAs everywhere) + SOC 2 for the commercial trust your partners require.
Global partners expect a recognized certificate. Layer ISO 27001 on the SOC 2 foundation — the control overlap is large.
What San Diego life-sciences operators Google before they commit.
If you sell software or data services to pharma, biotech, or healthcare enterprises, almost certainly yes — their vendor security questionnaires ask for SOC 2 by name, and the deal stalls until you have a report. SOC 2 is a commercial trust attestation (AICPA Trust Services Criteria), not an FDA requirement. A pure wet-lab or drug-development company that doesn't sell software may not need SOC 2 at all — its regulatory burden is 21 CFR Part 11 and GxP instead. So it depends on whether you're selling a product (SOC 2) or running regulated research/manufacturing (FDA path).
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures in FDA-regulated activities (drug development, clinical trials, medical devices, manufacturing). If any computer system you use creates, modifies, or stores records the FDA can inspect — an eTMF, LIMS, eQMS, manufacturing execution system — it must meet Part 11: validated software, audit trails, access controls, and compliant e-signatures. You need it if you're in the regulated drug/device lifecycle. A life-sciences SaaS that never touches GxP-regulated records usually does not.
They live in different worlds. GxP (Good Laboratory, Clinical, and Manufacturing Practice) is the FDA/EMA quality framework for labs, trials, and manufacturing — it demands Computer System Validation (CSV), documented procedures, and data integrity (ALCOA+). SOC 2 is a commercial security attestation that proves to customers your systems are trustworthy. GxP is about regulatory quality and patient safety; SOC 2 is about commercial trust. A biotech doing regulated work needs GxP/CSV regardless of SOC 2; a biotech SaaS selling to those companies needs SOC 2 regardless of GxP. Many need both, for different reasons.
Only if you handle protected health information (PHI) — identifiable patient data. A digital-health platform, a diagnostics company returning patient results, or a service processing clinical data tied to identifiable patients needs HIPAA (and BAAs with every vendor that touches that PHI). A drug-discovery company working with de-identified or molecular data typically does not. The test is simple: are you handling identifiable patient health information? If yes, HIPAA applies on top of your other frameworks; if no, it usually doesn't.
Sequence by what's blocking you. If a customer deal is stalled on a security questionnaire, do SOC 2 first — it unblocks revenue fastest. If the FDA or a regulated partner requires it, 21 CFR Part 11 and GxP/CSV are non-negotiable for the regulated systems and come first there. If you handle PHI, HIPAA is a baseline you can't skip. The good news: the technical controls overlap heavily — access control, audit trails, encryption, and change management feed SOC 2, Part 11, and HIPAA alike — so doing one builds most of the next. Start with the framework a real, named requirement is forcing, and reuse the evidence outward.