Pharmaceutical & Life Sciences IT
GxP-aware IT for pharma, biotech, and CRO businesses. 21 CFR Part 11 compliance, validated systems management, data integrity controls, and the audit-ready documentation FDA inspections demand.
- ✓ 21 CFR Part 11 expertise
- ✓ GxP-aware engineering
- ✓ Validated systems management
- ✓ Data integrity (ALCOA+)
Get a Free Pharma IT Assessment
A 30-minute conversation about your pharmaceutical, biotech, or CRO IT environment.
Pharma IT Has the Strictest Documentation Bar in Industry
21 CFR Part 11, GxP, validated systems, and FDA inspections create documentation and audit-trail requirements far stricter than typical regulated industries.
21 CFR Part 11 compliance
Electronic records and electronic signatures regulations apply to most pharma systems. Documented controls, audit trails, and validated workflows required.
GxP requirements
Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) — IT systems supporting these need GxP-aware engineering.
Validated systems
Computer systems involved in GxP processes require formal validation (URS, FRS, IQ, OQ, PQ documentation). Changes require revalidation; ongoing operations require maintained validation status.
Data integrity (ALCOA+)
Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available) — data integrity is foundational to FDA inspections.
Audit trail requirements
All changes to GxP-relevant data must be auditable, attributed to specific users, and tamper-evident. Electronic systems must enforce this technically.
Specialty software
LIMS (laboratory information management), ELN (electronic lab notebook), CTMS (clinical trial management), eTMF, MES — specialty platforms needing specialty support.
Pharma & Life Sciences-Specific IT
Six core capabilities sized for pharmaceutical companies, biotechs, CROs, and life sciences organizations operating under FDA jurisdiction.
GxP-Aware Engineering
IT operations and changes managed with GxP awareness — change control, documented procedures, and validation impact assessment for every action.
Learn more →21 CFR Part 11 Compliance
Electronic records and electronic signatures controls — audit trails, access controls, system validation, and tamper-evident change management.
Learn more →Validated System Management
IQ/OQ/PQ documentation, change control, periodic review, and revalidation when systems change. Maintained validation status for FDA inspections.
Learn more →Data Integrity Controls
ALCOA+ controls — audit trails, access controls, encryption, time synchronization, and tamper-evident change management.
Learn more →Audit Support
FDA inspection readiness — documentation, evidence collection, system demonstrations, and ongoing inspection support.
Learn more →Lab Software Support
LIMS (LabWare, STARLIMS), ELN (LabArchives, Benchling), CTMS, eTMF — specialty software support and integration.
Learn more →One Hire vs. an Entire Bench.
Hiring a single in-house IT person costs roughly the same as a full Datastrive managed support agreement — but a single person can’t cover 24/7, can’t be a senior network engineer and a cybersecurity specialist and a vCIO at the same time, and goes on vacation. Managed IT support gives you depth, redundancy, and predictable cost without the recruiting risk.
- Compliance-Aware Engineering. CIS Controls, HIPAA, PCI DSS, and cyber insurance.
- Predictable Flat-Rate Pricing. One monthly invoice covers everything.
- Proactive, Not Reactive. Most issues resolved before your team notices.
- Local Chicago-Based Team. Onsite at your office, not on the other side of a phone tree.
Switching IT Providers Shouldn't Be Painful
Three steps to a calmer environment. Most onboardings are completed inside two weeks.
Schedule Your IT Health Check
A 30-minute call to understand your business, your software, and the IT pain points actually slowing you down.
Onsite Discovery
We visit your office to inventory your network, workstations, and security setup — everything we need to build an accurate proposal.
Tailored Proposal
You get a clear, fixed-price proposal mapped to your team size, your software, and your goals — no surprise add-ons.
Managed IT Support Across Chicagoland
Frequently Asked Questions
Common questions about IT for pharmaceutical, biotech, and CRO organizations operating under FDA jurisdiction.
Do you have 21 CFR Part 11 experience?
How do you handle computer system validation (CSV)?
What about data integrity (ALCOA+)?
Can you support our LIMS or ELN?
How do you handle FDA inspections?
What size pharma businesses do you support?
Ready for IT That Holds Up to FDA Inspection?
Book a free 30-minute pharma IT assessment. We’ll review your validation posture, Part 11 compliance, and quote a fixed-fee proposal — no obligation.
- ✓ 30-minute pharma IT assessment
- ✓ Part 11 / GxP / data integrity review
- ✓ Inspection readiness check
- ✓ Response within 1 business hour
Get a Free Pharma IT Assessment
A quick conversation about your pharma or life sciences IT environment.