Your pharma and cosmetic QC lab, organized end to end
From the sample that hits the bench to the signed report, with full traceability, statistical quality control and a QMS that holds up under audit. One system, ready for ISO/IEC 17025.
The daily reality of bench QA/QC (and where it breaks)
QC analysts rarely complain about workload. They complain about rework: the same result typed into the notebook, then the spreadsheet, then the report. Every copy is a chance for error and an unanswered question at audit time. Here is where your day breaks down today.
You burn time proving where the data came from.
The same result lives in the bench notebook, the QC spreadsheet and the report. When the auditor asks for its origin, the hunt across three places begins.
You do not fully trust your own control chart.
Built by hand in Excel, with an acceptance rule only one person knows how to apply. If they are out, QC stalls.
You catch the out-of-calibration instrument too late.
It only surfaces at review, with the batch already released. Then the rework is rerunning the whole test.
Every ISO 17025 audit turns into a two-week project.
You gather calibration, QC, traceability and method-version evidence by hand, scattered across folders and spreadsheets.
You keep reference-material control in your head.
CRM expiry, stock, which lot went into which test. Easy to lose, and the auditor will ask.
The control chart is ready the moment you log the result.
The analyst logs the control on the bench and the system applies the QC rules and evaluation criteria right away, with certified reference material controlled by stock and expiry. No more chart built by hand in Excel.
- QC rules applied automatically to the result
- CRM controlled by stock and expiry
- No retyping the data into a spreadsheet
How Gerencialab solves it
The result is entered once and flows through the whole process: from the sample on the bench to the signed report, with nothing copied from one place to another. Here is what changes in your day.
Answer the auditor without leaving the screen.
Every sample carries the history of who did what and when, from the bench to the report. When they ask for the data's origin, you show it on the spot, no spreadsheet hunt.
The control chart is ready the moment you log the control.
QC rules aligned with ISO/IEC 17025 and evaluation criteria applied automatically to the result, with certified reference materials (CRM) controlled by stock and expiry. No more chart built by hand.
No one releases a batch with an out-of-spec instrument.
Equipment with expired calibration or a failed status is blocked from use. And the nonconformity is logged, handled and tracked inside the system, not buried in an email.
You are warned before calibration expires, not after.
Plans, records and validity in one place, with an automatic alert and an expiry traffic light. The right instrument is always in date when you run the test.
The report comes out standardized and signed, with no retyping.
Configurable template, variables filled automatically, generated PDF and signature on the document. Method and template versions under control, so the report tells its own story.
The instrument result comes in without manual entry.
Bring in results from instruments and spreadsheets without retyping value by value or fumbling a decimal place.
Compliance: what we actually deliver
Compliance is no place for vague promises, so we are direct about what we deliver and what we do not. On what matters for an accredited lab, you walk into the audit with your house in order.
You walk into the ISO 17025 audit with everything in place.
Accredited scopes, quality control, equipment, calibration, traceability and documentation in one system, no last-minute evidence gathering. Built for teams who live the standard.
Your data holds up to the auditor's hardest question.
Attributable, legible, contemporaneous, original and accurate records (ALCOA+), with an audit trail that preserves history. No one erases the past: the change is recorded.
The signed report is legally valid.
An ICP-Brasil digital signature gives the document legal validity in Brazil, with no extra notary or printing step.
You know up front what fits here and what does not.
Gerencialab does not currently offer 21 CFR Part 11 validation or an off-the-shelf GMP validation package. If your pain is QC lab operations, traceability and ISO 17025 audits, this is exactly where we deliver. If your requirement is formal computerized system validation for the FDA, talk to us first so we can set expectations.
You walk into the ISO/IEC 17025 audit with your house in order.
Every result becomes an attributable, legible, contemporaneous, original and accurate record (ALCOA+), with an audit trail that preserves history. The report is signed with ICP-Brasil and the technical lead stands behind it with legal validity.
- ALCOA+ traceability with audit trail
- Report signed with ICP-Brasil, the RT signs it
- Calibration and QC evidence in one system
What matters most for your QC
The solution is the whole system, but these are the ones pharma and cosmetic labs use most every day, and what each one saves you.
No result reaches the report without passing review.
Lab and Analyses: methods, parameters, service specification, execution and result review before release. The error is caught before it reaches the client.
Your analytical QC evaluated automatically, audit-ready.
Analytical Quality Control: QC rules, CRM with stock, evaluation criteria and tracking of control samples. The run comes back judged without you building a spreadsheet.
The right instrument, always in date.
Quality, Equipment and Calibration: equipment life cycle, calibration with alerts, maintenance and nonconformities, all in one place.
Reports in your format, signed and versioned.
Reports and Templates: configurable templates, standardized header and footer, signature and version control. You do not rebuild the document on every issue.
Every sample tracked from receiving to disposal.
Samples: receiving, labeled vials (barcode or QR), photos of the sample's condition, disposal with a logged reason and full traceability.
You know which supply went into each result.
Supplies and Inventory: consumables, controlled substances and regulatory bodies, with consumption linked per parameter. The answer for the auditor is already recorded.
Frequently asked questions
Does Gerencialab support 21 CFR Part 11?
Not today. We do not offer 21 CFR Part 11 validation or an off-the-shelf GMP package. We are strong on accredited-lab operations: traceability, statistical QC, QMS, ISO/IEC 17025 and ALCOA+. If your requirement is formal FDA compliance, it is worth a conversation first to set expectations.
Does it work for cosmetic and pharmaceutical analysis labs?
Yes. The focus is the quality control lab: physical-chemical and microbiological testing, sample traceability, QC and reporting. It fits the bench routine of teams working under ISO/IEC 17025.
How does instrument result import work?
The system imports results from instruments and spreadsheets into the analysis flow. Note: this is result import, not real-time serial interfacing with the instrument.
Is the report signature legally valid?
Yes, with an ICP-Brasil certificate, which carries legal validity in Brazil.
How long does implementation take?
Onboarding is guided, with us alongside you. Timing depends on the size of your method and parameter scope. In the demo we estimate it based on your lab.
See the system running against your real QC
You leave the demo knowing exactly how you will answer the auditor about any sample. With your methods, your samples and your reporting flow, we show traceability in practice.