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Data Quality & Integrity
Your Data Is a Regulatory Asset.
We Help You Treat It Like One.
Data quality and master data management services purpose-built for pharma, biotech, and medical device companies navigating GxP compliance, regulatory submissions, and the shift toward AI-driven operations.
Bad Data Doesn’t Just Slow You Down.
It Puts Everything at Risk.
In regulated life sciences, data integrity isn’t optional — it’s the foundation of every submission, every inspection, and every decision your organization makes. And yet, most companies are sitting on a patchwork of inconsistent master data, undocumented data flows, and quality gaps they don’t fully understand.
The cost? Failed inspections. Delayed regulatory submissions. Data migration projects that spiral. And AI initiatives that stall before they start — because the data feeding them was never trustworthy to begin with.
Whether you’re preparing for an FDA inspection, planning a system migration, or exploring how AI could accelerate your operations, the answer always starts in the same place: clean, governed, ALCOA+ compliant data.
Three Tiers of Data Quality Services
Scalable engagements designed to meet you where you are — from a one-time assessment to a fully managed data quality program.
Tier 1
Data Quality & Integrity Assessment
A focused, current-state evaluation that gives you a clear picture of where your data stands — and exactly what to fix first.
- Current-state data landscape audit
- Quality scoring across ALCOA+ dimensions
- Data flow mapping and gap identification
- GxP data integrity risk assessment
- Regulatory readiness evaluation (21 CFR Part 11, EU Annex 11, ICH Q9/Q10)
- Prioritized remediation roadmap with quick wins
Tier 2 — Most Popular
Master Data Management & Governance Framework
A practical, right-sized MDM and governance program that brings order to your data — without the bloated enterprise overhead.
- MDM strategy — simplified, practical, not overcomplicated
- Data ownership model and stewardship assignments
- Governance policies and SOPs
- Quality KPIs and monitoring dashboards
- Data standards and naming conventions
- Master data domain identification
- Integration architecture recommendations
- Change control processes for data
Tier 3
Managed Data Quality Program
Ongoing, embedded data quality support that keeps your program sharp — quarter after quarter, inspection after inspection.
- Ongoing data quality monitoring and reporting
- Quarterly business reviews with trend analysis
- Remediation support and continuous improvement
- Regulatory inspection readiness
- Data quality training for teams
- Annual governance framework review
Master Data Management —
Without the Complexity.
Here’s what we’ve seen too many times in life sciences: a company decides they need better master data management. A big consulting firm scopes a two-year, multi-million dollar platform implementation. Six months in, the project stalls. Eighteen months in, nobody trusts the data any more than when they started.
We take a different approach.
We help you start where you are — not where a vendor wants to sell you a $2M platform. Our MDM engagements are practical, phased, and right-sized for your organization. We identify your critical master data domains, establish governance that people actually follow, and build momentum with quick wins before scaling.
You don’t need a perfect MDM program. You need one that works — for your size, your systems, and your regulatory reality.
Data Quality Is the AI Prerequisite
Every pharma and biotech leader is talking about AI. But here’s the truth most vendors won’t tell you: you cannot build reliable AI on unreliable data.
Machine learning models trained on inconsistent master data produce inconsistent results. Predictive analytics built on undocumented data flows produce predictions nobody can validate. And in a GxP environment, unvalidated outputs aren’t just useless — they’re a compliance risk.
That’s why every Sakara Digital data quality engagement includes an AI-readiness data lens. We evaluate your data not just for current compliance, but for its readiness to power the intelligent systems your organization is moving toward.
Already exploring AI strategy? Our Launchpoint AI Roadmap service pairs seamlessly with data quality engagements — giving you a complete path from data foundation to AI execution.
Why Sakara Digital
Built for GxP From Day One
We’re not generic consultants who retrofitted a pharma practice. Regulated life sciences is all we do. ALCOA+ isn’t a buzzword here — it’s the lens we apply to every engagement.
Boutique Team, Embedded Approach
No revolving door of junior analysts. Our senior consultants embed alongside your team, learn your systems, and deliver work that sticks — not slide decks that gather dust.
ALCOA+ Native
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. We don’t just know the acronym. We build programs around it.
Practical Over Perfect
We believe in quick wins that build momentum. Every engagement delivers tangible improvements within the first 30 days — not a theoretical framework you’ll implement someday.
Cross-Functional Perspective
Data quality isn’t just an IT problem. We bring IT, Quality, and Operations perspectives together — because that’s how real data governance works in regulated environments.
Ready to Turn Your Data Into
a Strategic Advantage?
Schedule a free consultation to discuss your data quality challenges, regulatory priorities, and where a focused engagement could deliver the biggest impact for your organization.
Get in Touch
Tell us about your data quality goals and we’ll schedule a no-obligation consultation.