FAQ

How We Work:

1. Initial walk-through to assess needs requirement (Sign-up fee, including needs report).

2. Needs packages offered (suggested) based on initial condition of facilities.

3. Services booked based on available dates (50% deposit secures).

4. Fixed scope - no scope creep or extra hourly fees added.

Why I Started This

Most labs in Cape Town have brilliant scientists and overworked managers. What they don’t have is time to keep up with GCP, GCLP, and biosafety changes while running trials and diagnostics.

I started Lakay Lab Assurance to be the person you call 6 weeks before an inspection. I come in, find the gaps that actually matter, fix them with you, and make sure your team knows how to stay audit-ready after I leave.

No templates downloaded from Google. No 80-page reports you’ll never read. Just practical fixes that hold up when SANAS walks through the door.

What I’ve Done

• 19 years in lab operations, QA, and biosafety across clinical trials and diagnostics

• UCT experience: Built and maintained QMS for clinical trial labs under GCP and GCLP

• BSL2/BSL3: Risk assessments, facility reviews, and staff training for high-containment work

• Trained staff on SOPs, biosafety, and audit readiness

I’ve sat in the audit room. I know what inspectors ask, what they look for in 10 minutes, and what makes them dig deeper.

How I Work With You

I keep it practical 

If a fix takes 40 hours and gives 2% improvement, we don’t do it. I focus on the 20% of gaps causing 80% of audit risk.

I work in your lab

On-site or remote, I review your actual SOPs, records, and processes. No generic advice.

I leave you better than I found you

You get updated SOPs, training materials, and a simple system to stay compliant. The goal is that you don’t need me again next time.

Who I Work With

Lakay Lab Assurance is for:

• Clinical trial sites prepping for GCP/GCLP inspections

• Research labs managing BSL1/BSL2 work

• PIs and lab managers who’d rather focus on science than paperwork

Questions About Getting Your Lab Audit-Ready

General Questions

Q: Can’t my team handle audit prep in-house?

A: Often yes, if you have time and prior audit experience. Most labs I work with have great scientists but no one who’s sat through several SANAS or GCP inspections. I shortcut the process by telling you exactly what auditors check and where you’re exposed.

Q: Do you work outside Cape Town?

A: Yes. I’m based in Cape Town but work remotely across South Africa. For labs in the Western Cape, I prefer 1- 2 days on-site so I can see the actual processes. For the rest of SA, I will consider doing gap analysis and SOP reviews via Teams/Zoom and shared drives. Depending on availability, I might also visit labs in other provinces in person, but this is time dependent. Contact me directly to confirm.

Q: How long does it take to get audit-ready?  

A: Depends on where you’re starting. 

• Minor gaps: 1-2 weeks

• Full gap analysis and fixes: 3-6 weeks  

• ISO 15189 pre-accreditation: 6-12 weeks

I’ll give you a realistic timeline after the initial assessment. I won’t pad it to sell more hours.

Q: What standards do you cover?

A: GCP, GCLP, ISO 15189:2022, BSL1/BSL2 biosafety, and general GLP. If your standard isn’t listed, ask. If I haven’t worked with it, I’ll say so and refer you to someone who has.

Process & Pricing

Q: How much does this cost?  

A: Fixed project pricing, not hourly. You get the quote before we start, and payment is 50/50 upfront and on delivery.

Q: What’s included in the initial assessment?  

A: We map your audit date, current gaps, and risk level. I’ll tell you the 3 things to fix first and whether you need me at all. No sales pitch. If you don’t need me, I’ll tell you.

Q: Do you provide templates?

A: Yes, but not generic ones. I adapt SOP and record templates to your lab’s actual workflow. Auditors can spot a downloaded template in 30 seconds. Customised docs pass.

Q: Will you be in the room during the actual audit?

A: Usually no. My job is to make sure you don’t need me there. If you want me on-site for support, we can add it to the scope. Most clients prefer to run it themselves once they’re prepped.

About Me & Experience

Q: Have you actually passed these audits yourself?

A: Yes. I have been involved in labs running SANAS, NHREC, and sponsor audits. In my last job as the lab manager, I have personally come to know what causes panic and what doesn’t matter.

Q: Are you SANAS accredited? 

A: I’m a consultant, not an accreditation body. I prep you for SANAS, NHREC, and sponsor audits. I’ve worked with SANAS assessors.