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The Biotech and Life Sciences IT Security Guide

How to protect research data, secure lab instruments and get ready for partner diligence.

A starter data map for research data, instruments and IP
Instrument PC protection steps that respect validation
A self-assessment checklist for identity, lab networks, data and evidence
A 90-day plan, a plain-English glossary and 10 questions for any IT provider

11 pages24-item checklist30/60/90-day plan

Cover of The Biotech and Life Sciences IT Security Guide

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Cover and two sample pages of The Biotech and Life Sciences IT Security Guide, a free 11-page PDF guide from Alpiba with a 24-point checklist — A look inside: the cover and two pages from the 11-page PDF.

What's inside

Inside the guide.

Life sciences companies carry an unusual mix of IT risk. Instrument PCs run software that can't always be updated, research files are large and valuable, outside collaborators need access on short notice, and partners expect enterprise-grade security answers from a company where IT may still be someone's part-time job.

Use this guide as a working document. Read the five sections, score yourself with the checklist, then use the 90-day plan to sequence the work. Share it with your lab manager and quality lead, because the instrument and data integrity items need their input, and remember that nothing here replaces your validation process or regulatory advice. If you want a second opinion on your score, Alpiba offers a free 30-minute assessment.

Map what you're protecting
Secure instruments without breaking them
Protect IP as people come and go
Get ready for partner diligence
Plan for a bad day in the lab
The checklist24 items in 4 groups
Questions to ask any IT provider10 questions
Your 30/60/90-day plan3 phases, step by step
Plain-English glossary8 terms

Read Part 1 free

The opening chapter of the guide, in full. The rest of the guide, the checklist and the 90-day plan are in the PDF.

Map what you're protecting

You can't protect research you can't find. Start with a one-page data map that lists each kind of sensitive information, where it lives today, who can reach it and what would happen if it were lost, altered or leaked.

Starter data map for a research company
Information	Where it often lives	Main risk	First control
Raw instrument data	Instrument PCs, USB drives, local shares	Loss, alteration, ransomware	Automated transfer to backed-up storage
Analysis and reports	Laptops, personal cloud folders	Leakage, version confusion	Program-owned shared storage
ELN and LIMS records	Cloud research apps	Weak sign-in, orphaned accounts	Single sign-on with MFA
Patent drafts and IP	Email, executive laptops	Targeted phishing, leakage	Restricted site with DLP rules
Partner and data room files	External sharing links	Over-broad or permanent access	Expiring guest access, reviewed quarterly
Instrument configurations	Only on the instrument PC	Unrecoverable after a failure	Saved copy after every approved change

Look in the places people forget: instrument PC desktops, external drives in lab drawers, personal cloud accounts, old shared mailboxes and the laptop of whoever left most recently. That is where unprotected copies of research usually turn up.

Give each row an owner. The owner decides who gets access, approves exceptions and is the person IT asks when something changes.

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A preview

A sample from the guide.

Here's the first checklist group and a few of the questions. The full guide has all 24 checklist items, 10 questions and the 90-day plan.

Identity and access

MFA enforced for every user, administrator and app that supports it
No shared accounts on email, cloud apps or instruments where named users are possible
ELN, LIMS and other research apps sign in through the company identity
Admin rights kept separate from everyday accounts
Every guest and contractor account has an owner and an end date
Leavers lose access the same day, and their devices come back

Questions to ask any IT provider

1How would you protect an instrument PC that can't be patched without breaking vendor support or validation?
2How do you fit IT changes into our quality team's change control process?
3Who reviews alerts outside business hours, and how fast is your average first response?
4How do you control and log instrument vendor remote access?

+ 6 more questions in the full guide

Get the full guide Related: Biotech & Life Sciences

IT for biotech teams at a glance. Challenges: research ip is the business, lab instruments on older systems, collaboration with outside partners and growth that outpaces it. How Alpiba helps: research ip protection, segmented lab networks, secure partner collaboration and scale-ready it. Frameworks: SOC 2, ISO 27001 and NIST CSF. — IT for biotech teams at a glance.

Your first 30 days

Where to start this month.

The guide's 30/60/90-day plan begins with these steps. Assign an owner to each and review progress every two weeks.

1Build the data map and the instrument inventory
2Enforce MFA and retire shared accounts where the software allows
3Deploy managed EDR on every device that can run it
4Confirm research data has an immutable, off-site copy

Key terms in plain English

ALCOA+: Principles for trustworthy data: attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
Audit trail: A secure, time-stamped record of who created, changed or deleted an electronic record, and when.
ELN: Electronic lab notebook: software where scientists record experiments, methods and results.
LIMS: Laboratory information management system: software that tracks samples, workflows and results across a lab.
GxP: Shorthand for good practice regulations, such as good laboratory, manufacturing and clinical practice.
Network segmentation: Splitting a network into separate zones with rules between them, so each device can reach only what it needs.
Single sign-on (SSO): Signing in to many apps through one company identity, so MFA and offboarding apply everywhere at once.
Immutable backup: A protected backup that nobody, including an administrator or an attacker with admin rights, can change or delete until its retention period ends.