When your BI report needs to be as auditable as your batch record.
Regulatory submissions don't wait. Audit trails can't have gaps. Your reporting infrastructure needs to meet the same standard as your data integrity rules.
We speak GxP. Not just BI.
In pharmaceutical and regulated industries, a BI report is not a management convenience. It is a controlled document. Change the formula, trigger a validation cycle. Miss the audit trail, risk the submission. Your IT team knows this. Your regulators enforce it.
WizEmp™'s discovery process starts with your regulatory context. Which regulations apply? Who signs off on report changes? What is the current audit cycle? These questions determine the architecture before a single report is built.
Your data landscape is specific: SAP as your ERP backbone, LIMS for laboratory results, quality platforms for deviation and CAPA management, regulatory submission systems that speak their own language. The integration between these systems is the hardest problem. Data transformation must be documented at every step.
We have worked with SAP-centric environments in large industrial groups with the same data integrity requirements as pharma. We know what it takes to produce a report that a compliance officer, a quality director, and an external auditor can all stand behind.
Regulatory reporting is manual and deadline-driven
Your compliance team extracts from three systems, reconciles in Excel, and emails a PDF twelve hours before the submission deadline. One error resets the clock.
Audit readiness requires traceability BI can't provide natively
Power BI can display the number. It cannot, by default, show the chain from source record to published figure. That chain is what auditors require.
Reports are accepted even when wrong
Changing a known-incorrect report triggers a change control cycle. So the wrong number stays. Your team workarounds around it. The next team inherits the workaround.
Cross-border regulatory differences fragment your reporting
FDA, TGA, ASEAN harmonization. Each requires different data cuts from the same source. Three parallel Excel models. Three deadlines. Three teams who disagree on the definitions.
Quality has veto power, but no BI seat at the table
Quality and Compliance can block any IT initiative. They rarely get asked about reporting architecture until something fails. Wit changes that.
Discovery that understands validated environments.
Wit, WizEmp's smart discovery process powered by AI, runs structured anonymous interviews across all stakeholders before any report is built. Wit is tool-agnostic. The Shield of Truth, Data Dictionary, and Metrics Dictionary work regardless of whether your organisation runs Power BI, Tableau, Qlik, or Looker.
Vocabulary Wit uses in your environment:
Adaptation 01
Compliance personas interviewed first
Quality, Compliance, and Regulatory Affairs hold veto power over any BI deployment. Wit prioritises their interviews in Round 1. Their requirements shape the architecture. IT and Finance follow.
Adaptation 02
Regulatory definitions before data definitions
In regulated industries, some definitions are not negotiable. They are written in the regulatory framework. Wit surfaces which definitions are regulatory (fixed) and which are organisational (negotiable). The Data Dictionary reflects both categories.
Adaptation 03
Validation lifecycle mapped at discovery
Wit asks: Who signs off on report changes? What is the change control process? What is the current validation status of connected systems? The Shield of Truth includes a validation impact map before any architecture decision is made.
Adaptation 04
Anonymity is critical in regulated environments
Deviation records, CAPA history, audit findings. In most organisations, these topics are politically sensitive. Wit's anonymous interview structure means a quality manager can identify systemic reporting failures without career risk.
Adaptation 05
"MVP" becomes "validated pilot"
The vocabulary matters. WizEmp does not propose MVPs to regulated clients. We propose validated pilots: scoped, documented, with a defined qualification path. The first deployment proves the methodology. Expansion follows the validation sequence.
A Necessary and Sufficient Architecture for regulated reporting.
WizEmp delivers in Microsoft® Power BI®. Once the Shield of Truth™ is signed and the architecture defined, our team builds a Microsoft® Power BI® Cockpit: the navigation hub connecting all reports in your workspace. For a pharmaceutical or medical device company, the Cockpit links to reports that serve three master requirements: operational visibility, compliance readiness, and regulatory submission support.
If your organisation already runs Tableau, Qlik, or Looker, the Shield of Truth™ still applies. The discovery output (Data Dictionary, Metrics Dictionary, report architecture, signed stakeholder alignment) is platform-independent. You take it to your existing team or preferred integrator. WizEmp can support that path too.
Every Microsoft® Power BI® report WizEmp builds follows the Overview-Exploration-Detailed structure. A VP Quality sees the headline in 10 seconds. An auditor drills to source record in 2 minutes. The same report. The same data. Two different entry points.
Power BI Cockpit · Pharma Configuration
Your navigation hub: connecting every report in your workspace
Quality Performance
Regulatory Compliance
Production & Batch
Lab & LIMS Bridge
Financial HUD
Supply Chain
"Revenue in your regulatory submission is not revenue in your ERP. Wit surfaces these definitional conflicts before any report is built. The Data Dictionary and Metrics Dictionary are the first deliverables. Every report that follows draws from them."
Every function in your organisation. One coherent data architecture.
Quality & Compliance
Audit trail, CAPA tracking, deviation analysis, regulatory submission support. The reports your compliance team can stand behind.
Finance & FP&A
Cost of poor quality, batch cost vs. standard, regulatory cost allocation. When the BI report reconciles to your GL, your team stops exporting to Excel.
Operations & Production
Batch release cycle time, yield, right-first-time rate. Operational data connected to financial performance for the first time.
IT & Data Architecture
SAP, LIMS, QMS integration. Validated data pipelines. A semantic model your validation team can document and your auditors can trace.
Let's talk about your reporting challenge.
Your data already holds the answer. Most organisations never find it because no one built the right architecture to surface it.
Schedule a Discovery CallJust a conversation. Specific to pharma.