FHIR
Use FHIR to avoid manual reconciliation of life sciences data
Make regulated product and manufacturing data reusable, traceable, and submission-ready.
In many life sciences organizations, the data required for regulatory processes is spread across multiple sources, including internal systems like LIMS, MES, QMS, ERP, RIM, and external stakeholders like contract labs, and manufacturing partners.
The same product and manufacturing attributes are often defined differently across those platforms, which creates repeated reconciliation, weak traceability, and unnecessary manual effort.
This matters now more than ever, because regulatory processes are moving toward more structured, machine-readable data exchange.
In Europe, initiatives such as ePI and SPOR/PMS are accelerating the shift toward more standardized product data. In the United States, FDA’s PQ/CMC program signals growing interest in structured product-quality exchange, even though formal submission timelines are still evolving.
For life sciences companies, the challenge is not simply understanding the standards. It is being able to assemble, validate, govern, and reuse the right data across systems and functions without rebuilding it for every submission, variation, or product update.
Just as important, this approach can support structured exchange within and between companies and their stakeholders, including contract labs and contract manufacturers. That makes partner exchange one of the most immediate and practical applications today.
What we help you achieve
By using FHIR (Fast Healthcare Interoperability Resources) as an interoperability layer, NNIT helps life sciences organizations connect product and manufacturing data across internal systems and external partners, improve traceability and control, and build a reusable foundation for regulatory processes.
Equally important, we bring the organizational, regulatory, and domain expertise needed to establish the right data foundation for the technical solution.
Once implemented, a FHIR-based integration approach can create significant value that increases over time as the organization becomes familiar with the model and expands into new use cases.
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Reduce manual reconciliation across systems
Connect critical product, manufacturing, and regulatory data across your existing application landscape so teams spend less time collecting, comparing, and re-entering the same information in different formats.
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Improve traceability and data quality
Map critical data to governed structures and validate it earlier in the process so product and manufacturing information is more consistent, auditable, and reusable.
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Create a reusable regulatory data foundation
Move from document-centric handoffs and duplicated maintenance to a model where regulated data can be reused across submissions, regulatory processes, and related business workflows.
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Enable structured exchange with partners and regulators
Build the technical and governance foundations needed to support structured exchange with external partners today and evolving regulatory exchange models over time.
Typical use cases
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Product and manufacturing data harmonization
Align product, substance, packaging, and related data across ERP, RIM, quality, and manufacturing environments to reduce rework and inconsistency.
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Contract lab data exchange
Send structured study definitions to internal or external labs and receive results back in a reusable format that supports traceability, versioning, and downstream reuse.
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CMO change assessment exchange
Share structured specification or change-request bundles with manufacturing partners and receive results back in the same format for review, update, and downstream regulatory use.
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Structured content generation
Reuse governed structured data to support the generation of selected submission content and supporting documentation.
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Electronic product information readiness
Support the structured management and exchange of authorized product information in line with EMA’s ePI direction.
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PQ/CMC readiness
Prepare selected CMC and product-quality data for more structured handling and future exchange models as FDA’s PQ/CMC standards evolve.
How NNIT can help you
Depending on your needs, we provide everything from advisory, business analysis, data governance, technical implementation and FHIR-specific offerings.
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Assess where FHIR creates value
We identify the business processes, handoffs, and data dependencies where FHIR can reduce manual effort, improve control, and support regulatory objectives.
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Define the governed data foundation
We help align data definitions, ownership, validation rules, and governance responsibilities sothe underlying data can be trusted and reused across systems and teams.
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Implement the interoperability layer
We design and implement FHIR-based integrations, APIs, mappings, and validation services that connect source systems and structure data for regulatory use.
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Enable sponsor-to-partner data exchange
We help design and implement structured exchange patterns between sponsors and external stakeholders such as testing labs and manufacturing partners, so data can move through governed APIs and reusable bundles instead of manual documents and re-keying.
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Scale into additional use cases over time
We help establish a practical foundation that can expand beyond the initial use case into broader regulatory, quality, and product data use cases.
Insights from NNIT
ONLINE EVENT
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Inside the NDC-12 Industry Pilot: What Early Movers Learned
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Webinar: Content Governance in the Age of AI: Preparing Pharmaceutical Organisations for ePI and FHIR I by Docuvera & NNIT
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The Data Revolution in Pharma: How FHIR enables next level business outcomes for Quality, Manufacturing, and Regulatory
WHITE PAPER
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The NDC-12 Cross-Industry Pilot: Key Findings & Insights From Phase 0
ARTICLE
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How to build a universal translator for pharma data with FHIR
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A Practical Guide to IDMP Compliance
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Navigating the Transition from XEVMPD to PMS: Preparing for IDMP Compliance
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First Time Launch Alliance: Paving the Path to Successful Pharma Product Launches
Contact us
NNIT combines life sciences domain knowledge, regulatory understanding, data-governance capability, and hands-on implementation experience.
Contact us to learn more about how we can use FHIR to solve real operating problems across your internal systems, external partner exchanges, and regulatory processes.
