Quality culture that holds up to inspection
PCS doesn't write SOPs while your team continues current behaviour. We engage to change the behaviour first; the documentation and the inspection narrative follow. Senior partners only, on IGJ/FDA-grade engagements.
PCS team
Your PCS consultants for this engagement
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Jaap Koster
CEO of PCS
Founder of PCS, 43+ years pharma experience across NA, SA, Asia, Africa, Europe
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Riekert Bruinink
Senior GxP Consultant
Former EMA Senior & Coordinating GMP/GDP Inspector — co-author of the EU GDP Guideline
When this is the right fit
Specific situations where our compliance-to-culture approach earns its keep:
You just received an FDA 483 or IGJ inspection report with critical findings and need a defensible response in weeks, not months
Your latest inspection generated more critical findings than the prior cycle, and leadership wants the trend reversed before the next visit
More than 5 CAPAs have exceeded their 30-day closure target, and effectiveness checks consistently fail
Annual product review revealed systemic deviations across multiple batches that single-SOP fixes will not resolve
Shop-floor execution drifts between shifts or sites despite repeated retraining — work-as-done no longer matches work-as-written
Your inspection narrative is weak: records exist but the rationale, decision trail, and human story behind them cannot be told in front of a regulator
When this is NOT the right fit
We are direct about where our model does not apply. If any of these describes the brief, another firm will serve you better:
You need a tactical SOP rewrite without addressing the behaviour or root cause behind the findings
You are seeking a compliance certificate or clean audit letter without changing how operations actually run
You want the lowest day-rate option — our model is senior partners, not staff augmentation
Leadership is not prepared to back behavioural change on the shop floor or alter management routines
What you get
We focus on speed, clarity, and control—so your team knows what to do next and why.
Behavioural and systems readiness assessment
A senior partner walks the floor, sits with QA, and reviews systems against work-as-done. Output is a risk-ranked gap list grounded in what actually happens, not what the SOPs say.
Inspection narrative & evidence
A defensible inspection story tied to evidence: the decision trail, the rationale, and the human story behind the records — written so it stands up to a regulator across the table.
Remediation roadmap with behavioural workstream
30/60/90-day plan with named owners, decision points, and a parallel behavioural workstream — because closing findings on paper while behaviour stays the same is what got you here.
Senior partner engagement in delivery
PCS partners stay engaged through writing, training, implementation, and governance. We do not hand off to junior staff to keep the day rate down.
How we work
Pick a format that matches your urgency and internal capacity. Fixed-scope options available.
2–3 weeks
Assessment + roadmap
Typical deliverables
- Readiness assessment
- Risk-ranked gap list
- 30/60/90 plan
- Inspection narrative & evidence map
4–8 weeks
Execute top remediation actions
Typical deliverables
- Evidence package
- Training & readiness
- Oversight framework
- CAPA/Deviations closure acceleration
1–3 days/week
Interim + execution
Typical deliverables
- Interim QA leadership
- Hands-on delivery
- Capability transfer
- Sustained governance & reporting
Typical timeline
Partner conversation
A senior PCS partner sits with your sponsor to confirm the situation, the regulatory exposure, the stakeholders, and whether our compliance-to-culture model fits the brief.
Engagement scope (within 48 hours)
You receive a written scope: behavioural and documentation workstreams, named partners, timeline, decision points, and budget range for approval.
Delivery (weeks 1–8)
We change the behaviour on the shop floor first, then align the documentation and build the inspection narrative — owners and decision points named throughout.
What clients see
Example (anonymised)
A site faced repeated inspection observations and an increasing CAPA backlog. PCS performed a focused readiness review, created a risk-ranked remediation plan, and supported execution governance—resulting in a clearer inspection narrative and measurable closure progress.
See more clients and outcomes →"PCS brought clarity and control to a difficult situation. The approach was pragmatic, structured, and immediately actionable."
Frequently asked questions
Both. For diagnostics and sprints we often propose a fixed scope with clear deliverables; embedded support is typically time-based.
Depending on urgency and availability, we can often start with a triage call immediately and plan initial on-site work within days.
We typically combine both: on-site for shopfloor assessment and key workshops; remote for document reviews, governance, and execution support.
We support your internal ownership. We align roles early, build a realistic plan, and help your team execute with clear governance and capability transfer.