Business Analysis. Systems Strategy. Seamless Adoption.

Independent consulting that helps enterprises define, design, and deliver complex digital solutions — with a focus on risk-sensitive industries.

I'm Kunal Sengupta, Principal Consultant at OnspeQ Solutions. With more than 20 years of hands-on experience, I help organizations bridge business needs and digital delivery by enabling teams to:

✔️ Understand and streamline complex business processes.

✔️ Select and implement the right systems and solutions.

✔️ Align stakeholders, vendors, and teams around clear requirements.

✔️ Navigate quality, validation and compliance expectations in risk-sensitive environments .

✔️ Deliver technology-enabled change that lasts.

Whether you're defining a future operating model, evaluating solutions, implementing systems, or preparing for critical launches, I provide the structure, clarity, and hands-on support to help you move forward with confidence.

Connect with me on LinkedIn | Download my Resume

What I Do

My services are grouped into four core pillars that support your transformation from end to end:

1️⃣ Understand & Define

Align on where you are, and where you need to go.

🔍 AS-IS Process & System Assessment

I map your current processes, systems, and data to uncover pain points and opportunities.

🎯 TO-BE Blueprint Design

We co-create your future operating model and transformation roadmap.

⚖️ Gap & Impact Analysis

I identify gaps and impacts between your current and future state, turning them into clear, prioritized requirements.

💰 Business Case & Value Planning

I build strong business cases to secure funding and executive buy-in.

2️⃣ Design & Select

Define your solution and choose the right tools and partners.

📝 Requirements Engineering & User Stories

I turn business needs into clear specs and user stories that guide design and drive delivery.

🧩 Fit-Gap Analysis & Solution Evaluation

I evaluate solutions to ensure they truly fit your needs and minimize risks.

🗂️ RFP Support & Vendor Strategy

I help structure vendor evaluations, prepare RFPs, and support confident solution selections.

3️⃣ Build & Validate

Support development and ensure readiness for go-live.

⚙️ Development & Build Alignment

I work alongside your technical teams to keep priorities front and center, from build through launch.

✅ Test Planning & UAT Coordination

I design robust test strategies, coordinate user testing, manage defects, and ensure high-quality releases.

⭐ GxP Computer System Validation (CSV)

I deliver full validation support — risk-based assessments, protocols, traceability, and audit readiness, aligned to GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.

4️⃣ Adopt & Sustain

Ensure your teams are ready for change and set up for success.

📢 Change Management & Adoption Enablement

I help your teams embrace change confidently through clear communication, targeted training, and readiness support.

🏛️ Program Governance & Readiness

I set up governance and readiness plans, and keep stakeholders aligned for stable, sustainable performance.

Explore Skills and Experience

Why Me

✔️ Seasoned expertise — Over 20 years bridging business, technology, and operations with a balanced strategic and technical approach.

✔️ Independent and hands-on — Direct access to me throughout, no layers or juniors.

✔️ Fast, flexible, and pragmatic — Adapting quickly to your culture and tools to deliver results.

✔️ Proven track record — Successful delivery in complex, risk-sensitive environments.

✔️ Clear, actionable outcomes — Translating complexity into precise plans and solutions.

✔️ Flexible Engagements — From full projects to targeted support, I add value from day one.

Explore Skills and Experience

Clients & Collaborations

Some of the leading global companies I’ve worked with:

Let’s Talk

Have questions or a project in mind? Get in touch — I’d love to hear from you.

📩 hello@onspeq.ca

📞 +1 (647) 865-4783

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