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Pharmaceutical  ·  GxP Compliance

Northvale Therapeutics —
Global Pharma Intranet with GxP Tracking

Northvale Therapeutics — Princeton, NJ

18
Department sites — QA, QC, Regulatory, Clinical, Commercial, and more in one hub
97%
GxP training current — compliance rate visible on the portal home page
12
Open deviations tracked — 3 CAPAs past due surfaced with escalation alerts
3
SOPs requiring acknowledgement surfaced per user — tracked to individual completion
SharePoint Online SPFx Power Automate Microsoft Lists Microsoft Graph API Viva Learning SharePoint Search

A GxP-Regulated Pharma Company With Compliance Data Scattered Across 18 Teams

Northvale Therapeutics operates across 18 departments — from Quality Assurance and Regulatory Affairs to Clinical Development, Commercial Sales, and Pharmacovigilance. In a GxP-regulated environment, training currency, SOP acknowledgements, deviation records, and CAPA status are not just operational data; they are regulatory obligations that can be audited by FDA and EMA inspectors.

The company had no central visibility over these compliance indicators. GxP training completion was tracked by the Quality team in a spreadsheet updated monthly. SOP acknowledgement was managed by sending the PDF by email and chasing responses — there was no auditable record of who had read and acknowledged which version. Open deviations and past-due CAPAs were visible only in the quality management system, not surfaced to department managers or the leadership team.

The company had a Microsoft 365 tenant but no single intranet. Each of the 18 departments had built their own SharePoint site independently, with no shared navigation, no cross-department news feed, and no unified way for employees to reach regulatory updates, company news, or compliance obligations from one place.

GxP training completion tracked in a monthly spreadsheet — no real-time view, no per-user gap visibility

SOP acknowledgements managed by email — no auditable record, no tracking to individual staff

Open deviations and past-due CAPAs not visible outside the QMS — management had no early warning

18 independent SharePoint sites with no hub — no cross-department navigation, no shared news feed

A Global Intranet Hub With Compliance Tracking Built In

The Northvale Hub was built as a SharePoint hub site connecting all 18 department sites, with a custom SPFx home page that surfaces GxP compliance indicators alongside company news, upcoming events, and department cards. The home page is designed around the compliance obligations that Northvale's QA team monitors daily — deviation count, CAPA status, SOP acknowledgements, and GxP training currency — surfaced as a priority row above the department grid.

SOP acknowledgement tracking was rebuilt as a Power Automate workflow. When a new SOP version is published to SharePoint, the flow creates an acknowledgement record in Microsoft Lists for each staff member who must read it, sends them a Teams notification with a link, and marks the record complete only when the staff member clicks "Acknowledge" in the portal. The result is an auditable, timestamped per-person per-SOP-version record — the 3 outstanding SOPs are surfaced to each user on their home page panel.

The 18-department card grid links each department to its own SharePoint site with a live badge showing open deviations or pending approvals. A regulatory & compliance bulletin section aggregates posts tagged "regulatory" from across all department sites. An approval queue consolidates outstanding items from Power Automate flows for the signed-in user. A company events calendar synced with Outlook surfaces upcoming site visits, training events, and inspection readiness dates — including the 18-day countdown to the next readiness review.

What Was Delivered

GxP compliance dashboard — training %, open deviations, CAPA status, and days to readiness review
SOP acknowledgement tracking — per-person per-version records with auditable timestamps
18-department card grid — each linked to its department site with live compliance badge
Regulatory & compliance bulletin — tagged posts aggregated from all department sites
Personalised approval queue — consolidated outstanding items from Power Automate flows
Deviation & CAPA tracker — open items with owner, due date, and escalation status visible on home page
Hub site architecture connecting 18 department sites with shared navigation and search

Northvale Therapeutics Global Intranet Hub

Compliance Obligations Visible on the Home Page — Not Hidden in a QMS

97%
GxP training current — surfaced live on the hub home page, not in a monthly report
3
Past-due CAPAs visible on login — QA team can escalate without digging into the QMS
Auditable
SOP acknowledgement records — per-person, per-version, timestamped — inspection-ready
18
Department sites connected under one hub — shared search, navigation, and compliance bulletin

Built for GxP-Regulated Operations on Microsoft 365

SharePoint Hub Site
Hub site architecture connecting all 18 department sites with shared navigation and tenant-wide search
Architecture
Microsoft Lists
Deviation log, CAPA tracker, SOP acknowledgement records, and compliance training tracking lists
Data
SPFx + React
Custom web parts for compliance dashboard, department cards, SOP panel, and regulatory bulletin
Frontend
Power Automate
SOP acknowledgement flow, CAPA escalation alerts, deviation notification, and training reminder flows
Automation
Microsoft Graph API
Per-user SOP acknowledgement status, approval queue, and training record queries via Graph
Integration
Viva Learning
GxP training courses surfaced in the portal — completion tracked and surfaced in the compliance row
Training
SharePoint Search
Cross-hub regulatory bulletin aggregating tagged posts from all 18 department communication sites
Search
SharePoint Document Library
Version-controlled SOP library — major versioning with approval workflow before acknowledgement trigger fires
Documents

Ready to Build This?

Build a GxP-Ready Intranet on SharePoint Online

We design and build compliance-aware intranets for pharmaceutical, medical device, and life sciences companies on SharePoint Online — SOP acknowledgement tracking, CAPA visibility, GxP training compliance surfaced daily, all within Microsoft 365.