SOC 2 used to be something only SaaS companies worried about. That's changed. Enterprise pharma partners, academic medical centers, and Series B investors now routinely ask life sciences companies for SOC 2 reports — or equivalent security assurance — as part of partnership and investment diligence. If you don't have a SOC 2 report, you're increasingly asked to explain why.
This post is a practical starter roadmap for biotech and life sciences companies approaching their first SOC 2 audit.
What SOC 2 Actually Is
SOC 2 (Service Organization Control 2) is an auditing framework developed by the AICPA. It evaluates a company's controls related to five Trust Services Criteria: Security (required), Availability, Processing Integrity, Confidentiality, and Privacy (all optional). Most life sciences companies scope their SOC 2 to Security plus Confidentiality, since those are what partners and investors care most about.
There are two types of SOC 2 reports:
- Type I: Assesses whether your controls are designed appropriately at a point in time. Useful as an intermediate milestone but increasingly insufficient on its own.
- Type II: Assesses whether your controls operated effectively over a period of time (typically 6-12 months). This is what most enterprise partners and sophisticated investors want to see.
How SOC 2 Maps to Life Sciences IT
If you're already working toward 21 CFR Part 11 compliance, you've done a significant portion of the SOC 2 Security criteria work. The overlap is substantial:
- Access control requirements (Part 11's unique user IDs) map directly to SOC 2's CC6 (Logical and Physical Access Controls)
- Audit trail requirements map to SOC 2's CC7 (System Operations) monitoring requirements
- Backup and recovery requirements map to SOC 2's A1 (Availability)
- Change control procedures map to SOC 2's CC8 (Change Management)
This means that for a life sciences company running a Part 11 compliance program, achieving SOC 2 alignment is a documentation exercise more than a control implementation exercise — you're mapping what you already do to the SOC 2 criteria framework.
The 12-Month Roadmap
Months 1-3: Scoping and Gap Assessment
Define the scope of your SOC 2: which systems, which services, which criteria. Conduct a gap assessment against the SOC 2 criteria. Most first-timers have 15-30 gaps to close, ranging from documented policies that don't exist yet to technical controls that need to be implemented or verified.
Months 4-6: Remediation
Close your gaps in priority order. Start with the technical controls that take time to demonstrate (you need evidence of controls operating over time) before the policy documentation work. Common remediation items: formal security policies, vendor management procedures, formal change management process, security awareness training program, and penetration test.
Months 7-9: Observation Period
SOC 2 Type II requires controls to operate over an observation period. During this time, you're running your program and collecting evidence: access review records, patch reports, training completion logs, change control tickets, backup test results. Your auditor will review these at the end of the period.
Months 10-12: Audit and Report
Your SOC 2 auditor (a licensed CPA firm) reviews your evidence, interviews your team, and produces the Type II report. The audit process typically takes 4-8 weeks. You receive a report that either has no exceptions (clean) or lists exceptions with management's response. Clean SOC 2 reports are achievable for first-time audits with proper preparation.
Choosing an Auditor
SOC 2 audits must be performed by a licensed CPA firm with relevant technology audit experience. For life sciences companies, it's worth selecting an auditor with experience in regulated environments — they'll understand when a control is Part 11-driven and won't ask you to justify why your audit trail review happens quarterly rather than monthly.
Common First-Timer Mistakes
- Scoping too broadly: Your first SOC 2 scope should be limited to what your partners are actually asking about. Don't try to cover every system and every Trust Services Criterion in year one.
- Under-investing in evidence collection: The SOC 2 audit is an evidence review. If you run good controls but can't demonstrate them with documented evidence, you'll get exceptions. Build evidence collection into your operational processes from the start of the observation period.
- Starting too late: If a partner is asking for a SOC 2 report on a six-month timeline, you're already behind for a Type II. Type I is achievable faster; Type II requires the observation period. Set expectations early.
For more on our security and compliance services, see Propellio Security & Compliance.
This article is part of Propellio's series on IT for life sciences and biotech. See related: Security Compliance.
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