A quality system your operators actually use
A PQS that exists on paper does not pass an EU GMP inspection in 2026 and does not run a 24/7 manufacturing site. PCS rebuilds maturity by changing how the system is run day-to-day — compliance moves from a binder to operational DNA.
PCS team
Your PCS consultants for this engagement
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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 PQS situations where our compliance-to-culture model is the right answer:
Your annual product review surfaced systemic deviations across multiple batches that point to PQS-level failure, not isolated events
Your QMS exists on paper but work-as-done diverges visibly between teams, shifts, or sites
A recent EU GMP inspection cited PQS effectiveness — governance, management review, or change control — as a critical observation
Change control, deviation, or validation decisions routinely miss their target turnaround, and KPIs measure activity instead of outcomes
More than 5 CAPAs have exceeded their 30-day closure target and effectiveness checks are largely a formality
Document management has grown so heavy that operators have built workarounds, and you cannot tell from records what actually happened
You want to stop being inspection-ready and start being in control — and you are willing to change leadership routines, not just SOPs
When this is NOT the right fit
Disqualifying triggers — we are clear about where another firm will serve you better:
You want to refresh procedures and templates without touching how leaders run the system day-to-day
You are looking for the lowest day-rate option — our model is senior partners, not staff augmentation
You need a compliance certificate or letter of opinion rather than measurable change in PQS execution
Leadership is not prepared to alter management review, escalation, or KPI behaviour as part of the engagement
What you get
A PQS that operators can run and a regulator can defend — not a heavier binder.
PQS maturity assessment grounded in work-as-done
Senior partners walk the floor, sit with QA, and benchmark each core process against EU GMP and ICH Q10 expectations — separating the procedure from how the work actually runs.
Risk-based improvement roadmap with governance
A 30/60/90 plus longer-horizon plan with named owners and dependencies, including the leadership routine changes required for the plan to land.
Process redesign & simplification
Pragmatic redesign of deviations, CAPA, change control, and supplier management — fewer steps, clearer decision rights, and less room for the workarounds operators currently rely on.
Control model embedded into management routines
Roles, escalation paths, and a KPI / management review structure that drives decisions in the room — not a dashboard nobody acts on. We stay engaged until the routines hold without us.
How we work
Pick a format that matches your urgency and internal capacity. Fixed-scope options available.
2–3 weeks
Assessment + roadmap
Typical deliverables
- Maturity scan of key QMS/PQS processes
- Execution check: shopfloor reality vs. procedure
- Risk-ranked improvement roadmap
- Leadership readout with decisions required
4–10 weeks
Implement priority improvements
Typical deliverables
- Redesign 1–3 priority processes (e.g., CAPA/change control)
- Templates, guidance, and training for consistent execution
- Oversight framework and KPI setup
- Proof of control and inspection-ready evidence
1–3 days/week
Interim + execution
Typical deliverables
- Interim QA leadership or QMS owner support
- Hands-on coaching and decision support
- Sustained rollout across teams/sites
- Capability transfer to internal process owners
Typical timeline
Partner conversation
A senior PCS partner aligns with your sponsor on the system pain points, the sites and products in scope, the regulatory exposure, and whether our compliance-to-culture model is the right answer.
Engagement scope (within 48 hours)
You receive a written scope: priority workstreams, named partners, governance changes required from leadership, timeline, and budget range — focused on the biggest risk and performance levers.
Delivery (weeks 1–10)
We assess maturity through work-as-done, rebuild priority processes, change the management routines that run them, and embed governance so control survives our exit.
What clients see
Example (anonymised)
A growing organisation had strong documentation but inconsistent execution and slow decision-making. PCS mapped the end-to-end QMS flow, identified maturity gaps, redesigned key processes, and introduced a practical governance model—resulting in faster closure of deviations/CAPAs and clearer management oversight.
See more clients and outcomes →”PCS helped us simplify without losing control. Decisions became faster, roles clearer, and the system started working for operations instead of against it.”
Frequently asked questions
Yes. We align improvements with applicable GxP requirements and use risk-based principles to keep the system pragmatic and defensible.
Yes. We focus on simplification with control—removing duplication, clarifying responsibilities, and improving usability without increasing compliance risk.
We plan changes in sprints and prioritise high-impact areas first, with governance that supports operations rather than pausing them.
Yes. We can combine implementation with targeted training and coaching so execution becomes consistent and sustainable.