IT Infrastructure for Pharma & Life Sciences
GxP-compliant network infrastructure, clean room connectivity, laboratory systems, and cold chain monitoring for pharmaceutical and biotech facilities.
100%
GxP Compliance
ISO 7/8
Clean Room Rated
24/7
Cold Chain Monitoring
Pharmaceutical & Life Sciences
Challenges We Solve
Meeting GxP, FDA 21 CFR Part 11, and HIPAA compliance requirements
Deploying networks in clean room and controlled environments
Ensuring validated systems with full audit trail documentation
Supporting cold chain monitoring for temperature-sensitive products
What We Deliver
Pharmaceutical & Life Sciences Infrastructure Services
GxP-compliant network architecture with validation documentation
Clean room-rated cabling and wireless access points
Laboratory instrument network connectivity
Cold chain environmental monitoring systems
Data integrity infrastructure for electronic records
Secure VPN and remote access for clinical teams
Results
Why It Matters
Full FDA 21 CFR Part 11 compliance with audit trails
Clean room-rated infrastructure maintaining ISO classifications
Validated network documentation for regulatory inspections
Continuous cold chain monitoring with automated alerts
Related Services
Services That Power Pharmaceutical & Life Sciences Solutions
Validated Networks
GxP-compliant network infrastructure with IQ/OQ/PQ documentation.
Learn moreData Integrity
Cloud and on-premise infrastructure supporting 21 CFR Part 11 electronic records.
Learn moreFacility Security
Access control and surveillance for clean rooms, labs, and controlled substance areas.
Learn moreOur Approach
How It Works
GxP Compliance Assessment
We assess your facility against GxP, 21 CFR Part 11, and EU Annex 11 requirements — documenting qualification needs for clean rooms, labs, manufacturing areas, and cold chain storage systems.
Validated Infrastructure Design
Our engineers design infrastructure supporting validated environments including clean room connectivity, environmental monitoring, LIMS integration, and data integrity controls required for regulatory compliance.
Controlled Installation
Installations follow pharmaceutical facility protocols including gowning procedures, clean room entry protocols, and change control documentation. All work is logged in your quality management system.
IQ/OQ/PQ Qualification
We execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols — providing validation packages ready for FDA and EMA audits.
Common Questions
Pharmaceutical & Life Sciences IT Solutions FAQ
Can you work inside classified clean rooms?
Yes. Our technicians are trained in clean room protocols including proper gowning, particle control, and contamination prevention. We schedule work during maintenance windows and follow your facility SOPs for clean room entry.
How do you handle 21 CFR Part 11 compliance for network systems?
We design infrastructure supporting electronic signatures, audit trails, access controls, and data integrity requirements mandated by 21 CFR Part 11. This includes redundant storage, validated backups, and tamper-evident logging.
Do you provide IQ/OQ/PQ documentation?
We provide complete validation documentation including Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports. Documentation is formatted for your quality system and regulatory submissions.
Can you install cold chain monitoring systems?
We deploy validated environmental monitoring systems for cold chain, ultra-cold storage, and controlled room temperature environments. Systems provide continuous logging, threshold alarms, and compliance reports for GDP and GMP requirements.
How do you handle change control for pharmaceutical infrastructure?
All infrastructure changes follow your change control process. We provide pre-installation impact assessments, execute approved change orders with full documentation, and support post-change qualification testing before systems return to production use.
Compliant Infrastructure for Life Sciences
Summit DNC builds validated, GxP-compliant IT infrastructure for pharmaceutical manufacturers, biotech companies, and clinical research organizations.