Internal Audit & Self-Inspection
Independent support for internal audit and self-inspection programmes.
Inspected at the source,trusted to the end.
Independent, on-site supplier and CMO audits for importers who qualify partners across the medical cannabis supply chain.
Long-term success in the medical cannabis industrydepends on an effective Pharmaceutical Quality System.
We work on that system with you in four ways.
Supplier & Contractor Qualification
Risk-based audits supporting qualification, requalification and ongoing oversight.
Outsourced Quality Assurance
Senior QA support inside your operations, when you need it.
Project-Based QA Consultancy
Focused expertise for defined quality, compliance and improvement projects.
How the audit works
How good is it to know where you stand? From self-inspection to supplier qualification, our audit method is the first step towards a state of control.
01Audit Scoping
We start with you to define why the supplier is being audited, the scope, criteria, sites and timeline, plus the required deliverables.
- 02
Supplier Documentation Review
You share what you already hold. We request and review the supplier’s PQS documentation and audit history, plus available data, to focus the audit.
- 03
Audit Planning
We turn the agreed scope into a clear audit plan, then coordinate the agenda, interviews, sampling and access with the supplier.
- 04
Audit Execution
At the supplier’s site, we assess systems and processes, interview staff, sample records and collect objective evidence.
- 05
Conclusions & Reporting
We present conclusions to the supplier, classify each finding and issue the final report you need to support your supplier qualification decision.
- 06
CAPA Follow-Up
If the follow-up is in scope, we review the supplier’s CAPA response and supporting evidence, then report back to you on whether the supplier addressed the findings adequately.
Fill in four steps and we send your quotation.
Why trust us
Improvised expertise is still common in medical cannabis. Since 2023 we have signed our work with our names and based it on professional judgment and technical competence, standards we apply to ourselves first.
Member of Confindustria Genova since 5 August 2026.
Riccardo Longato
Pharmaceutical GMP Lead Auditor (CQI/IRCA)
GMP Pharmaceutical Quality Systems Lead Auditor course (PR325), certified by CQI and IRCA
RSSL, 2026
GMP and GxP supplier and CMO audits, GACP to EU GMP gap assessments, CAPA follow-up
Asia, Africa and Europe
PQS design, supplier qualification, mock inspections and inspection readiness
Medical cannabis and regulated active-substance supply chains
ISO 9001:2015 Management System Auditor training
Implementation and internal-audit experience across ISO 9001, ISO 14001 and ISO 45001
Production-process sampling training
60 hours
The team behind the scenes
Alongside our pharmaceutical-quality work, Fabrizio leads the management-system side of the business outside the pharmaceutical sector and heads the software development team behind the applications and AI tooling those systems run on.
Fabrizio Longato
Quality consultant and AI specialist, founder of Clear S.r.l. Società Benefit and managing partner of Clear Italia
Over twenty management systems implemented across ISO 9001, ISO 14001 and ISO 45001
QMS and integrated management systems designed for industrial organisations of different sizes and sectors
Internal-audit experience across quality, environmental and occupational health and safety management systems
Management-system work focused on operational efficiency and risk reduction
Software and AI development applied to management systems, with internal applications, document and record handling, and automation of recurring compliance work
Graphic design diploma, with brand identity in Illustrator and Photoshop, 3D in Blender and video in DaVinci Resolve
Qualified ISO 9001 Management Systems Auditor, with foundational GMP training
Third-party sources that name Clear
Written about by
From pre-audit review to the final report,one engagement covers the complete supplier-audit cycle.
Single-site supplier audit
Our most requested service
We quote each audit on its own, based on the scope, the standard we audit against and where the site is.
Request a quotationIncluded in the engagement
Pre-audit review & planning
Scoping call, supplier PQS review and audit planning
On-site audit execution
Systems, processes, interviews, records and objective evidence
Conclusions & final audit report
Findings classified, the report issued, and CAPA follow-up where in scope
Travel arrangements
We quote travel separately and book nothing without your approval.
We bill professional work done during travel separately and never count it again as travel time.
Travel time is billed by the hour
Capped at eight hours per one-way journey.
Expenses at cost
Pre-approved, itemised and without mark-up.
You control the booking
You book directly, or reimburse us against receipts.
12-hour arrival buffer
For journeys over 5 hours or across 3 time zones or more.
Would you rather talk it through first?
Questions clients ask us before commissioning an audit.
Yes. The report provides independent, traceable evidence for your qualification file. Your Quality Unit retains the approval decision, supplier status and any conditions under your Pharmaceutical Quality System.
Yes. Where you have your own procedures, checklists and report format, we run the audit against them and deliver the report in your format. Where you do not, we use ours and hand them over with the report.
We agree the criteria with you in the scoping call and write them into the audit plan. They can be EU GMP and its annexes, GACP, the relevant GxP, your own quality agreement, or a combination of them. We assess only against criteria agreed in advance.
Yes, once you have introduced us. We send requests, the agenda and documents through one channel agreed with you, and we copy you on every request and document we send the supplier.
We classify each finding as critical, major or minor, state the objective evidence behind it and the requirement it refers to, and present it to the supplier at the closing meeting, before we issue the report.
We fix the date with you in the scoping call and write it into the audit plan alongside the deliverables, before the audit starts. If the report has to fit a qualification schedule, raise it in that call.
Yes, when it is in scope. We review the supplier’s corrective actions and the evidence behind them, and we tell you whether each finding has been adequately addressed or remains open.
We record it in the report as a limitation of scope, against the part of the audit it affected. The report states what we could not assess and why, so you decide on what we saw.
We confirm the detailed scope and the contractual points before the engagement.