Inspection readiness & remediation
Prepare confidently for FAGG/AFMPS/IGJ/FDA inspections and remediate GMP/GDP gaps with a clear plan, strong evidence, and hands-on execution support.
When this is the right fit
Common triggers we see before inspections or during remediation projects:
Upcoming FAGG/AFMPS/IGJ/FDA inspection or internal audit escalation
Recent major/critical findings or repeated observations across inspections
Deviation/CAPA backlog increasing, weak effectiveness checks, slow closure
Inconsistent execution of SOPs on the shopfloor or between shifts/sites
Evidence gaps: incomplete records, unclear rationale, weak inspection story
What you get
We focus on speed, clarity, and control—so your team knows what to do next and why.
Readiness assessment
Focussed review of systems and shopfloor execution, with risk-ranked gaps.
Inspection narrative & evidence
Clear "inspection story", evidence mapping, and document readiness.
Remediation roadmap
30/60/90-day plan with owners, timelines, and decision points.
Hands-on execution support
Support in writing, reviewing, training, implementation, and governance to keep momentum.
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
Triage call (20 minutes)
Confirm urgency, scope, stakeholders, and key risks.
Scope confirmation (48 hours)
You receive a clear plan, timeline, and budget range for approval.
Delivery (weeks 1–8)
Assess, prioritise, execute, and build a controlled evidence trail.
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.