What IT due diligence should a biotech prepare for funding?
Biotech IT due diligence checks whether your company controls its data, IP and regulated records and can recover them. Prepare a system and data inventory, proof the company owns its accounts and domains, MFA and access-review evidence, backup and restore records, security policies and incident history, key vendor contracts, and, for GxP systems, validation and Part 11 evidence. Gaps you find first are cheaper than gaps a reviewer finds.
What reviewers are trying to learn
- Ownership: research data, code and domains sit in company-owned accounts, not a founder's personal cloud or a former employee's mailbox.
- Protection: access is controlled, MFA is enforced, and departures are offboarded promptly.
- Recoverability: backups exist, are isolated and have actually been restored.
- Regulated readiness: systems that hold or will hold GxP records can meet Part 11 and predicate-rule expectations.
- Third parties: CROs, CDMOs, SaaS vendors and collaborators handle your data under written terms.
Build the data room before you are asked
- Inventory of systems and SaaS tools, with owner, data held and whether each is GxP.
- Identity summary: directory, MFA coverage, admin accounts, last access review.
- Backup design and the date and result of the last restore test.
- Security policies, training records and any incident history with remediation.
- Contracts and data-use agreements covering CROs, cloud services and licensed datasets.
- A self-assessment against NIST CSF 2.0 with a dated improvement plan.
GxP evidence if you run regulated work
If you are in or approaching GMP, GLP or clinical work, reviewers will look for a computerized system inventory with GxP classification, validation or assurance records for each regulated system, audit trail configuration, SOPs and training. FDA continues to enforce Part 11's access controls, authority checks and electronic signature provisions, and expects validation effort to follow a documented risk assessment, so show both the controls and the rationale.
Common findings
The issues that most often surface are easy to describe and slow to fix: research data in personal accounts, shared lab logins, no restore test, unmanaged SaaS bought on credit cards, contractors who still have access, and spreadsheets used for regulated calculations without controls. Each one weakens the story that your data and IP are under control.
A short written plan with owners and dates for each gap usually lands better than a claim that everything is fine.
When to start
Start before the raise or partnering process begins, not when the first questionnaire arrives. Fixing account ownership, MFA coverage and backup testing takes weeks of normal operations, and reviewers notice when evidence is dated the week before the data room opened. A brief readiness review against NIST CSF 2.0 gives you the inventory, the gaps and the plan in one place.
Common follow-up questions
Do investors require SOC 2 before funding a biotech?
There is no legal requirement, and expectations vary by investor and partner. Most reviewers look for evidence of control: owned accounts, MFA, backups, policies and a framework-based plan. A partnering deal with pharma may bring its own security questionnaire.
How should we handle data held by CROs and collaborators?
Show contracts that define data ownership, security expectations, breach notification and return or destruction of data at the end. Keep a list of which external parties hold which datasets and who at your company can grant or remove their access.
What if our GxP systems are not validated yet?
Say so and show the plan. A system inventory, risk classification and dated validation schedule tied to your clinical or manufacturing timeline demonstrates control. Hiding the gap is riskier than presenting it with owners and dates.
LAN Service Group provides IT strategy and fractional CIO-style leadership for life-science companies, including IT readiness reviews, system inventories and remediation plans ahead of financing or partnering diligence.
Talk to LAN Service Group (888) 281-7243