Gap Assessments & Mock Audits That Reveal What Matters
PCS engages when you need an honest external view of how your quality system actually behaves — not how it reads. We test SOPs against operational habits, walk the floor with the questions an inspector would ask, and hand back findings that change behaviour rather than fill a binder.
When this is the right fit
PCS engages with QA leadership and site management when:
A competent authority inspection is anticipated within the next 6 months and the last external assessment is more than 24 months old
A merger, acquisition or site integration has brought a new operation under your quality umbrella and you cannot independently confirm its compliance state
You just received a 483 with critical findings, or major findings at a sister site, and the executive committee needs an independent view of comparable risk
Recurring deviations, repeat CAPAs or repeat audit observations suggest the internal review process is missing systemic issues
A new product line, process technology or licence variation is going live and the supporting system has not been externally stress-tested
When this is not the right fit
When you should look elsewhere
- You need a checklist-driven paper review without on-site observation of how processes actually run
- You want a clean report to reassure stakeholders rather than findings that may require investment to fix
- You are seeking the lowest day-rate option — our assessments are led by senior partners with inspection and operational backgrounds
- You do not have a sponsor willing to act on the findings, including the uncomfortable ones
What you get
Every assessment produces actionable output. We do not deliver findings without a clear path to resolution.
Structured Gap Assessment Report
A comprehensive report that maps your current systems, processes, and documentation against applicable regulatory requirements. Each finding includes the specific regulatory reference, observed evidence, risk rating, and recommended corrective action.
Risk-Prioritised Remediation Plan
A practical action plan that sequences remediation by inspection risk. Critical and major gaps are addressed first with clear owners, deadlines, and success criteria. This is a working document, not a shelf report.
Mock Audit with Feedback
Realistic mock audit sessions that test your team's responses, documentation readiness, and process understanding. Immediate feedback identifies coaching needs and process gaps that paper reviews miss.
Management Summary & Benchmarking
An executive-level summary that communicates compliance posture in business terms. Based on our experience across 260+ organisations, we provide context on where your site sits relative to industry expectations.
How we work
We scale the assessment to match your scope and objectives. Three standard formats:
1-2 weeks
Targeted review of specific systems or areas of concern
Typical deliverables
- Assessment of defined scope (e.g., data integrity, deviation handling, warehouse operations)
- Findings report with risk prioritisation
- Management briefing with recommendations
3-5 weeks
Comprehensive review across all GMP/GDP quality system elements
Typical deliverables
- End-to-end quality system assessment
- Complete remediation roadmap with phased implementation
- Mock audit sessions for critical areas
Ongoing
Regular assessments to maintain continuous compliance visibility
Typical deliverables
- Quarterly or semi-annual focused assessments
- Trend tracking and compliance metrics
- Rolling remediation management and progress reporting
Typical timeline
Scope Definition & Document Review
We agree on assessment scope, applicable standards, and logistics. Key documentation is reviewed before the site visit so on-site time focuses on verification and interviews rather than reading SOPs.
On-Site Assessment & Mock Audit
Our assessors review processes, interview personnel, inspect facilities, and test documentation trails on-site. Mock audit elements are integrated where agreed. You receive preliminary findings before we leave.
Reporting & Remediation Planning
Within one week of the site visit, you receive the complete gap assessment report with prioritised findings and a remediation plan. A management briefing ensures leadership understands the implications and next steps.
What clients see
Example (anonymised)
A contract manufacturing organisation requested a full-site GMP gap assessment ahead of an anticipated regulatory inspection. The assessment identified 47 findings across six quality system areas, including three critical gaps in data integrity practices. PCS delivered a phased remediation plan and supported implementation over eight weeks. The subsequent inspection resulted in no critical findings.
See more clients and outcomes →"The assessment was thorough but never adversarial. They found things our internal audits had missed for years and gave us a realistic plan to fix them. We were genuinely ready when the inspector arrived."
Frequently asked questions
A gap assessment is a systematic review of your quality system against regulatory requirements -- it examines documentation, processes, and practices comprehensively. A mock audit simulates an actual inspection scenario, testing how your team responds to inspector-style questioning and document requests. We often combine both for the most complete picture.
We assess against EU GMP (EudraLex Volume 4), EU GDP (2013/C 343/01), WHO GMP, FDA expectations, and PIC/S guidelines depending on your regulatory environment. For multi-standard sites, we can assess against combined requirements in a single engagement.
Internal audits are essential but can be limited by familiarity and organisational blind spots. An external gap assessment brings independent perspective, cross-industry benchmarking from hundreds of assessments, and the objectivity that comes from having no stake in the findings.
Yes. Focused assessments targeting specific areas -- such as data integrity, laboratory controls, deviation management, or warehouse operations -- are common and effective. We define the scope based on your risk priorities.
Yes. We can support remediation implementation through hands-on consultancy, from rewriting SOPs to coaching your team on new practices. Many clients start with an assessment and then engage us for targeted remediation support.