Audit-ready evidence
Validation artifacts and controls that stand up to scrutiny without slowing delivery.
Compliance & Delivery Studio
Make compliance predictable. Deliver faster. Stay audit-ready.
Plan.kim helps regulated businesses validate systems (CSV), implement GAMP 5 risk-based controls, and run delivery programs (Agile or PMI) without losing speed or governance.
Focus
Pragmatic compliance and delivery
Coverage
Validation, governance, service operations
Outcome
Audit-ready and delivery-ready teams
Pick your path
Focused services for regulated delivery.
Compliance & Assurance
Risk-based validation, operational controls, and audit-ready evidence for quality-critical work.
Explore serviceDelivery
Agile and hybrid delivery systems that keep teams fast while leadership stays in control.
Explore serviceService Management
ITSM design with clear ownership, automation-first workflows, and practical governance.
Explore serviceAI / LLM Enablement
Use-case discovery, guardrails, and working solutions that keep AI safe and useful.
Explore serviceOutcomes
Outcomes that support audits and delivery.
Reduced risk
Operational and security controls aligned to intended use and data integrity.
Clearer ownership
Roles, decisions, and accountability that make programs easier to run.
Predictable delivery
A delivery cadence that balances speed, scope, and governance.
Safer AI adoption
Guardrails and enablement that reduce unintended exposure and drift.
How we work
A phased approach that keeps delivery safe.
We align teams, controls, and evidence so compliance becomes a predictable part of daily delivery.
Diagnose
Clarify intended use, constraints, and priorities through focused discovery and risk review.
Build
Design the operating model, controls, and delivery system with pragmatic artifacts.
Operate
Embed ownership, training, and reporting so the system stays reliable over time.
Deliverables gallery
What your teams receive.
Every engagement ends with clear artifacts, ownership, and a working delivery rhythm.
- Validation classification and intended use statements
- Risk assessment and traceability matrices
- Test strategy and evidence packs
- Operational control designs and SOP outlines
- Agile or hybrid delivery playbooks
- Service catalog and workflow blueprints
- AI governance policies and prompt standards
- Runbooks, handover notes, and reporting templates
Articles
Practical guidance for regulated teams.
Compliance & Assurance
CSV for GDP: a pragmatic path to validated systems
A practical approach to validation that protects data integrity and audit readiness without slowing delivery.
Read articleCompliance & Assurance
Risk-based validation without paperwork fatigue
How to keep validation evidence lean, focused, and aligned to intended use.
Read articleCompliance & Assurance
NIS2 readiness roadmap for operational leaders
A readiness-led approach that blends governance, controls, and delivery cadence.
Read articleFAQ
Answers to common questions.
What kinds of organizations do you work with? +
Plan.kim works with regulated businesses that need compliance without slowing delivery. The focus is on quality-critical operations, data integrity, and audit readiness.
Engagements range from single system validation to cross-team delivery programs and service management redesigns.
How do you balance agility with governance? +
We design lightweight controls that map to intended use and risk, not to abstract frameworks. This keeps teams moving while leadership stays confident.
Governance is embedded into the delivery rhythm through clear decision points, evidence capture, and ownership.
Do you replace internal teams? +
No. We work alongside your teams to strengthen the system, clarify responsibilities, and remove friction.
The goal is to leave behind a model your teams can run independently.
What makes your compliance approach pragmatic? +
We focus on intended use, data integrity, traceability, and controlled change. Documentation exists to support those needs, not as paperwork for its own sake.
Evidence is designed to be reusable across audits and operational reviews.
Can you support multi-vendor programs? +
Yes. We provide hybrid governance that keeps delivery aligned across vendors, contracts, and internal teams.
The focus is on dependency control, decision clarity, and cadence alignment.
How do you approach AI and LLM enablement? +
We start with use-case discovery and risk framing, then build guardrails for access, retention, and vendor oversight.
Working solutions are delivered with training, prompt standards, and adoption support.
Do you provide ongoing support? +
Yes. We can stay involved to operate controls, maintain evidence, or coach delivery teams as they mature.
Support is designed around ownership transfer and long-term stability.
What artifacts should we expect? +
You receive concise deliverables such as validation plans, traceability, test evidence, service catalogs, and governance playbooks.
Artifacts are designed to be used in operations, not just filed for audits.
How do we get started? +
Start with a short alignment call where we clarify scope, constraints, and priorities.
From there, we propose a focused plan that matches your operating model.
Is your work aligned to recognized frameworks? +
Yes. We map to CSV, GAMP, GDP, ITIL, and common delivery standards, but apply them in a risk-based, practical way.
The approach is always tailored to your systems and governance needs.
Ready to talk
Let’s make compliance predictable.
Share your goals and constraints, and we’ll propose a practical path forward.