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I will guide your new machine or system from urs to fat, sat and qualification
A. Slimani
About this gig
Most security and data integrity problems on a new line are created at purchase: a URS that did not ask, a FAT run on the supplier's terms, a qualification that only tested the happy path. I make sure your next machine or system arrives compliant, secure and documented.
What you get
- A URS chapter for cybersecurity, data integrity and IT/OT integration, each requirement with its verification method
- FAT and SAT protocols you control: acceptance criteria, raw data, deviations, configuration baseline
- IQ/OQ test scripts, a traceability matrix and the reuse justification for supplier tests (EU GMP Annex 15)
- User training and handover documents, so your team owns the system on day one
Why me
I support new systems and packaging lines in pharma from specification through FAT, SAT and qualification to user training, and I lead OT cybersecurity across several sites. I read a machine as an automation engineer, a network engineer and an auditor at once.
Remote by default, on-site on request. NDA on request. English, French or Arabic.
Get to know A. Slimani
A. Slimani
OT and ICS Cybersecurity Manager, IEC 62443, NIS2, ISO 27001, GxP, Industrial AI
- FromMorocco
- Member sinceAug 2025
- Avg. response time1 hour
Languages
English, Arabic, French
18 years on industrial sites, from OT automation and ICS to cybersecurity, IT infrastructure, digital transformation and regulation. I lead OT/ICS cybersecurity for a multi-site pharmaceutical cluster: risk, remediation, procedures, incidents, audits and awareness. I secure and modernise plants without stopping production: IEC 62443, NIS2, ISO 27001, IT/OT convergence, GxP data integrity (21 CFR Part 11, ALCOA+), new machines from URS to qualification, industrial AI (RAG, agents). PECB NIS 2 Lead Implementer, Cisco CCNA. English, French, Arabic.
Other Regulatory Compliance Consulting Services I Offer
FAQ
At which stage should we involve you?
Ideally before the purchase order, when the URS is written. Later also works: I then review the supplier's documents and shape the FAT, SAT and qualification tests.
Can supplier FAT tests replace our IQ/OQ tests?
Some can, if the protocol was approved beforehand, data are traceable and transport cannot affect the function (EU GMP Annex 15, 3.6). I build that reuse matrix test by test.
Do you attend the FAT in person?
Remote witnessing is in the top package or added per day. On-site attendance is quoted through a custom offer, with travel priced upfront.
Do you train our users?
Yes. The top package includes user and administrator training on the security and data integrity functions, with training records for your quality system.
Is this only for pharma?
No. The method fits any regulated or critical production: pharma, cosmetics, food, chemicals. Pharma adds the GMP qualification layer.
