Why biotech companies work with us
Biotech is a tale of two environments. On one side: scientists who need to adopt new tools the moment they appear — a new ELN, a new AI-driven structure-prediction service, a new cloud-HPC provider — because research velocity is the moat. On the other side: validated systems (LIMS, eTMF, document management, regulatory submissions, pharmacovigilance) where every change has to be documented, tested, and signed off because regulators will read the audit trail later.
Most MSPs collapse those two worlds into one — and the result is friction in both directions. Scientists wait too long for IT to bless a new SaaS tool; QA + regulatory teams worry that the same fleet running validated workloads is also running every experimental browser extension a postdoc found useful. Our biotech clients run a single goCloudOffice subscription that respects the line between the two.
What is included for biotech
- Foundation The same operational base every customer starts with.
- 360SmartIT Department Endpoints, identity, helpdesk, MDM
- Validated systems layer GxP-unique controls for systems under regulatory validation.
- IQ / OQ / PQ documentation Per validated system
- 21 CFR Part 11 controls Audit trails, e-signatures
- Locked patch cadence No auto-updates without QA review
- Dedicated AISA queue Higher human-engineer escalation default
- Change-control documentation Per modification
- Risk-matched add-ons Layered on per pharma-partner + insurer expectations.
- 360CyberProtect MDR Pharma vendor-questionnaire requirement
- 360CloudBackupPro Research data + validated workstations
- 360M365Backup Sponsor retention, eTMF spillover
- 365 Security Reviews QA + diligence evidence
- Lab + research platforms Customer-owned platforms we run alongside, not as resellers.
- ELN systems
- LIMS
- eTMF
- Regulatory submission tools
- Cloud-HPC providers
One stack, four tiers of obligation. The validated layer is what turns 'general IT for an SMB' into 'IT for a regulated biotech.' Pro1 covers routine engagement work — laptop swaps, account resets, MDM enrollment; Pro2 / Pro3 Master engineers cover validated-system work — IQ/OQ/PQ, 21 CFR Part 11, GxP audit support — billed per minute only when authorized.
Every engagement starts with 360SmartIT Department — managed endpoints (Windows + Mac), continuous security baseline enforcement, automated patching with maintenance-window awareness, and unlimited AISA support tickets — and adds the components that biotech operating reality demands:
- 360CyberProtect MDR — 24/7 SOC oversight with human analysts. Most biotech cyber-insurance underwriters now require active monitoring, and most pharma partners include MDR in their vendor-security questionnaires. We provide the operational evidence — deployment coverage, alert volumes, response times — on the same business day the underwriter or partner asks.
- 360CloudBackupPro — point-in-time backup with 30-minute recovery granularity. For research data, configuration of validated workstations, and the documentation trail that follows them. Ransomware-resilient by design.
- 360M365Backup — daily Exchange / OneDrive / SharePoint / Teams backup beyond Microsoft’s recycle-bin window. For sponsor-required communication retention and the eTMF spillover that lives in M365.
- 365 Security Reviews — Standard — quarterly review of the M365 / Google Workspace tenant against the controls your QA + regulatory teams (and your investors’ diligence teams) expect. Surfaces drift before auditors do.
- Pro1 / Pro2 / Pro3 Master engagement — Pro1 handles routine biotech IT (laptop swaps, account resets, MDM enrollment); Pro2 / Pro3 Master cover validated-system work — IT-side support for IQ / OQ / PQ documentation, 21 CFR Part 11 technical-control implementation, GxP audit support, and IT input on validation master plan reviews. Your QA, regulatory, and validation leads remain the document owners and approvers; we provide the IT execution and evidence. Billed only when authorized, in 5-minute increments.
Validated systems vs. everything else
We treat your validated systems differently from the rest of your fleet — by design. Validated workstations get a separate management profile: locked patch cadence, change-control documentation per modification, no automatic agent updates without QA review, and a dedicated AISA queue with a higher human-engineer escalation default. Everything else (research laptops, scientist Macs, admin computers) runs on the standard goCloudOffice baseline. Both environments live under one subscription, one bill, one customer-success relationship — but each operates with the discipline its workload requires.
Lab + research platform integrations
We work alongside the platforms most biotech teams run — Benchling and LabArchives for ELN, LabWare and STARLIMS for LIMS, Veeva Vault and Montrium for eTMF, Veeva RIM and Ennov for regulatory submissions, GraphPad Prism and Geneious for analysis, and AWS / GCP / Azure for cloud HPC — as the IT partner who understands how those platforms intersect with your endpoint, identity, and validated-systems posture. The platforms remain customer-owned; we keep the surrounding stack stable.
Lab instruments + HPC
We support the awkward edges of biotech IT: the Windows 7 instrument-control PC the regulator requires you to keep until the validated method is re-validated, the Linux GPU cluster running structure prediction overnight, the instrument-specific Mac running an old version of Mass Hunter that the vendor stopped updating in 2018. We document, isolate, and protect — facing each problem squarely.
Investor + partner diligence
When your Series B investor’s diligence team asks for evidence of your information-security controls, or when a Big Pharma partner sends you a 200-question vendor-security questionnaire as a precondition for the licensing deal, the answers should already exist. We maintain the documentation continuously: information-security policy, incident-response plan, BCDR plan, vendor-management list, training-completion records, evidence of backup discipline, evidence of access reviews. The artifact is ready when you need it.
Built for biotech operating cycles
Biotech headcount changes quickly — from 8 founders to 35 in a Series A round, from 35 to 95 after Series B, from 95 to 250 going commercial — and per-computer pricing means your IT line item scales with hiring without a contract renegotiation. When you wind down a research program, you remove the seats. We are built around that volatility, treating it as expected behavior.