IT consulting for healthcare providers and pharmaceutical companies
We connect EHR, lab, pharmacy and ERP systems, and we build HIPAA and FDA requirements into the design so the audit trail comes from the system itself.
What gets in the way in healthcare and pharma
Clinical systems that do not share data
EHR, LIMS, pharmacy, imaging and ERP platforms each have their own data model and access rules. Staff re-key patient and order data between them, and every workaround is an audit risk.
Compliance added after go-live
HIPAA Security Rule controls and 21 CFR Part 11 audit trails are often documented after a system is built. Controls that were never part of the design are hard to prove to an auditor.
Validation work for GxP systems
Manufacturing, quality and clinical systems need computer system validation under GAMP 5, with URS, FS, IQ, OQ and PQ records. Paper batch records and manual sign-offs slow every change.
Older systems that cannot produce an audit trail
Systems built before current rules often cannot log who accessed PHI or who changed a record. Replacing them risks clinical operations, so they stay in place until an inspection forces the issue.
How we help healthcare and pharmaceutical teams
We design and test HL7 and FHIR interfaces between EHR, LIMS, pharmacy, imaging and ERP systems, with documented mappings and error handling for each feed.
Service details Cybersecurity and RiskWe implement access control, PHI encryption and audit logging to HIPAA Security Rule requirements, and prepare the evidence your compliance team needs for reviews.
Service details Custom Application DevelopmentWe build and configure clinical and operational applications, including 21 CFR Part 11 electronic signatures and audit trails, with a validation package under GAMP 5.
Service details Cloud ModernizationWe move clinical and research workloads to HIPAA-eligible AWS, Azure or GCP configurations, sequenced around clinical dependencies with a tested cutover and recovery plan.
Service details AI and DataWe build governed data platforms for clinical, trial and quality data, with lineage and retention rules that hold up in regulatory submissions.
Service detailsWhat we work with
We place interoperability engineers with HL7 and FHIR experience, cloud and DevOps engineers, data engineers, QA and validation analysts for GxP systems, and security engineers who have worked in HIPAA environments.
- HL7 and FHIR
- HIPAA
- EHR
- LIMS
- FDA 21 CFR Part 11
- EU Annex 11
- GxP
- GAMP 5
- Computer system validation (CSV)
- EMA
- AWS
- Azure
- GCP
- GDPR
The kind of work we do here
Replacing point-to-point clinical interfaces with a FHIR layer
A health system connects its EHR, lab, imaging, pharmacy and billing systems through hundreds of HL7 v2 point-to-point interfaces. Each new app or partner means another custom interface, and failures are hard to trace.
Read scenarioA cloud migration that keeps GxP validation intact
A pharmaceutical company wants to move quality and manufacturing systems to the cloud. An earlier attempt copied on-premise controls into the cloud and left an expensive hybrid that satisfied neither IT nor quality assurance.
Read scenarioFinding safety signals in adverse event reports sooner
A drug safety team reviews adverse event reports by hand and looks for signals on a quarterly cycle. Volumes keep growing, and a missed signal carries regulatory and patient risk.
Read scenarioCommon questions
Can you work with protected health information?
Yes, under a business associate agreement put in place with you before anyone on our team has access to PHI. Access is limited to the people and systems the work needs.
Do you deliver validation documentation for GxP systems?
Yes. For validated systems we follow a risk-based approach under GAMP 5 and hand over the URS, specifications, test protocols and results with the system.
Which EHR and lab systems do you integrate?
We work through standard HL7 v2 and FHIR interfaces and vendor APIs, so the approach is the same across EHR, LIMS, pharmacy and imaging platforms. Tell us your systems and we will confirm what we have worked with.
Can you help us prepare for a HIPAA or FDA review?
Yes. We review access controls, audit logging and documentation on the systems in scope, fix the gaps, and set up the system to produce the evidence an auditor asks for.