How long does a typical engagement last?
Advisory review: 2-4 weeks. Embedded support: 3-9 months. Program oversight: 12+ months. The engagement model is chosen based on the scope and the client team's capacity.
Methodology and Working Approach
A short, evidence-based playbook for how pharmaceutical automation, GxP validation, and smart factory engagements are run. Built on the observation that most programs fail for the same five reasons, regardless of vendor, technology, or budget.
Five operating principles
(1) Evidence first: every recommendation must point to a record an inspector can retrieve. (2) The system owner is the answer: no architecture decision moves forward without a named accountable owner. (3) Inspectors see the same view on Tuesday as during an audit. (4) Phased rollout over big-bang replacement. (5) Procurement is a design decision shaping the next 10 to 15 years.
Engagement phases
Phase 0: Discovery and scope (1-2 weeks). Phase 1: Strategy and roadmap (2-4 weeks). Phase 2: Pilot (3-6 months) — implement the smallest valuable scope, validate, train, measure. Phase 3: Rollout (6-18 months) — expand to the next site or system, repeat the pilot pattern. Phase 4: Steady-state operations (ongoing) — establish the operating routine that maintains the system.
Decision framework
Six-step framework: (1) What is the business outcome? (2) What evidence do we have? (3) Who is the named owner? (4) What is the rollback plan? (5) What is the inspection-readiness impact? (6) What is the cost of delay? Decisions that fail any step are deferred or rejected.
What we do not do
We do not provide recommendations that cannot be traced to evidence. We do not go dark between milestones. We do not replace the client's team. We do not sell vendor products.
How to use this page
Use this Methodology and Working Approach page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For Methodology and Working Approach, prepare the records, owners, risks and decision criteria linked to five operating principles, engagement phases, decision framework, what we do not do. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
What is the communication cadence?
Daily standup with the immediate workstream team. Weekly written status to the program sponsor. Monthly executive review (60 min). Quarterly roadmap refresh (2 hours).
How are disagreements with the client handled?
If the client insists on a decision that is not evidence-based, the disagreement is documented and the client's decision proceeds under their signature. The practice does not undermine the client's authority, but does not pretend to agree when it does not.