21 CFR Part 11 & ISO 17025 in Practice: What Your LIMS Must Actually Do
21 CFR Part 11 and ISO 17025, clause by clause: audit trails, e-signatures, document control, and what your LIMS must actually do.
READ MOREConfident LIMS and Lab Zen are partnering to help peptide labs plan instruments, methods, and the sample-to-COA workflow together.

Opening a peptide testing lab means making three big decisions at once: which instruments to buy, which methods to validate, and how every sample will move from receipt to report. Get them out of sync and the launch stalls.
🎧 Prefer to listen? Here's the full audio version of this article:
Confident LIMS and Lab Zen have partnered so you can plan all three together. Lab Zen brings the instruments, method development, and validation support. Confident LIMS brings the configurable Laboratory Information Management System (LIMS) that runs your lab's daily workflow.
We're not starting from scratch. Together, we already support 10+ peptide labs, and this partnership turns that experience into a coordinated setup for the next ones.
The partnership gives peptide labs one coordinated path from the bench to the report. Lab Zen helps you source, validate, and support your instruments and methods. Confident connects that work to sample intake, review, and Certificate of Analysis (COA) delivery, so your lab starts testing with fewer handoffs and less re-entry.
Lab Zen supports analytical labs through every stage, from opening to daily operation. Its team supplies high-quality refurbished equipment, services instruments, and provides method development, validation, and application support. They've opened and operated labs themselves, and that experience shapes how they plan a launch.
Confident LIMS is a configurable LIMS for peptide testing labs. It connects sample login, configurable test panels, HPLC and LC-MS results, review, and client reporting in one system. Your clients order tests, track samples, and download COAs through the Client Portal, part of a 15,000+ client network.
"After successfully onboarding several startup peptides labs recently, we learned that many new labs need to source pre-configured instruments, equipment and supplies rapidly and reliably, but often didn't have the time or experience to do this in the peptides industry. That's why we partnered with Lab Zen: to give our rapidly-growing base of peptides lab customers a full-service 'out-of-the-box' solution to get up and running quickly and in compliance."
Steve Albarran, CEO of Confident LIMS
Demand is coming from more than one direction. In the Alliance for Pharmacy Compounding's 2025–2026 survey, 55% of responding pharmacies had compounded semaglutide or tirzepatide within the previous two years (APC survey). A 2026 Gallup survey found that 18% of current GLP-1 weight-loss users reported taking a compounded or custom-mixed version (Gallup).
Then there are the cosmetic formulators and supplement brands building peptides into serums, creams, and collagen products. Each client brings a different material, a different question, and a different report.
That's where precision matters. Chromatographic purity and peptide content answer different questions. Water, counterions, and related impurities all affect how much of a sample's weight is actually the target peptide (Bachem explains the distinction).
So your report has to say exactly what you measured. That means keeping the submitted sample, method, units, reviewed results, and report version connected, every time. A "99% pure" result with no method or measurement basis behind it isn't an answer. It's a question your client will ask later.
For a closer look at identity, purity, and quantity testing, read what peptide testing labs need to keep up.
Start with the basics: your proposed testing menu, instruments, team, and launch priorities. From there, the work splits cleanly.
The goal is practical. Less re-entry, clearer handoffs, and fewer delays between finished testing and released reports.
As you grow, Confident's audit trails, role-based review steps, and e-signatures help you meet expectations like ISO/IEC 17025 and 21 CFR Part 11. Your timeline still depends on your scope. A coordinated plan helps you move quickly without cutting corners on validation.
"We've opened and run labs ourselves, so we know the instruments are only half of a launch. The other half is how samples, methods, and results move through the lab every day. We've selected Confident LIMS as the preferred LIMS that we recommend to our labs, so peptide labs get the instruments, process, and software they need from day one."
Adam Floyd, CEO of Lab Zen
Opening a peptide lab or adding peptide testing to your services? Tell us about your plans in the form below. Lab Zen and Confident will both receive your details and follow up by email about equipment, methods, and your lab's software workflow.
🎧 Short on time? Here's the podcast brief:
You need a defined testing menu, instruments suited to it (typically HPLC and LC-MS), validated methods, trained staff, and a system that tracks every sample from receipt to report. Lab Zen helps with the instruments and methods. Confident runs the sample-to-COA workflow.
Yes. Many labs add peptides alongside their other services. A configurable LIMS lets you add peptide test panels and COA templates without running a second system.
It should identify the submitted sample and lot, the methods used, results with clear units and measurement basis, and any limitations. HPLC area purity isn't the same as peptide content, so the COA should state which one you measured.
You share your plans once, through the form on this page. Lab Zen scopes the equipment and methods, Confident scopes the workflow, and both teams follow up by email to coordinate next steps.
Let's share!