Healthcare & Life Sciences
If it is not documented, it did not happen.
An undocumented change is a deviation, and a data gap is an investigation. Inspectors and accreditors both work from the same question: can you prove who did what, when, and under whose approval.
Every electronic batch record depends on hardware that passes regulatory scrutiny.
The audits you have to pass
Every one of these asks IT for something. We build the controls that produce it.
FDA 21 CFR Part 11
Electronic signatures, timestamped audit trails, and human-readable record retention.
GAMP 5 CSV Validation
Installation Qualification (IQ) and Operational Qualification (OQ) protocols for all network gear.
WHO-GMP Cleanroom Standards
Flush-mount stainless faceplates, IP66-sealed outlets, and non-shedding cabling jackets.
NABH / ABDM Health Records
Encrypted patient health data repository with role-based clinical access controls.
Environmental SCADA Monitoring
Continuous cold-room temperature telemetry logging with immutable sensor records.
DPDP Act 2023 for Health
Patient biometric, diagnostic, and prescription privacy safeguards with strict consent trails.
What changes for you
Three outcomes that ensure regulatory compliance and seamless batch release.
Zero audit observations
Validation packs and timestamped trails satisfy international drug inspectors on first review.
Cleanroom contamination proof
Sealed containment and stainless fixtures survive aggressive disinfectant washdowns.
No lost clinical data
Air-gapped medical PACS archives protect patient history against ransomware.
How we build it
Each stage produces something an auditor would accept.
Survey
Cleanroom classifications, lab instruments, and regulatory scope audited.
Validate
IQ/OQ test protocols drafted and pre-approved by quality assurance.
Deploy
Sealed infrastructure installed and dressed to cleanroom protocols.
Execute
Formal IQ/OQ execution sign-offs and Fluke calibration certificates issued.
Audit evidence you can hand over
Documentation is the deliverable. All of it is yours, in the format assessors expect.
Pharma & Healthcare IT Audit Readiness Checklist
The evidence an FDA, WHO-GMP, or NABH auditor asks for, and where each item comes from in your infrastructure.
Planning an IT Audit or Infrastructure Assessment for Healthcare & Life Sciences?
Get an on-site technical assessment and audit-readiness review from our certified enterprise architects.
