Pharma OS · by FixityTech
Eight purpose-built modules — LIMS, DMS, TMS, QMS, CPV + APQR, AI Document Review, QMD Pro, and Pharma Lens — sharing one audit trail and one set of roles.
21 CFR Part 11 · GMP Compliant · ALCOA+ · ICH Q10
Pick a module to see what it does, how it flows and what it looks like.
A single system of record for the full QC test lifecycle — from sample receipt and registration, through analyst raw-data worksheets, to QC-reviewed and QA-approved certificates of analysis. Every action is e-signed, every field is auditable, every workflow enforces segregation of duties.
The 9 stages
9 stepsSRO Staff
QC Analyst
HOD / Designee
QC Analyst
Designed for traceability, accountability, and data integrity from sample receipt to certificate of analysis.
Workflow · sample to signed COA
QC Inward registers it and allocates a registration number.
Owner · QC InwardThe analyst picks the Raw Data Worksheet, captures readings and submits for QC review.
Owner · AnalystApproves or sends back; approved fills roll into the Test Report Worksheet (COA).
Owner · QC ReviewerQA Head approves and the COA is dispatched to the customer.
Owner · QA HeadRunning in parallel
Analyst Qualification
Qualifies analysts on each technique.
Planners
Schedule recurring GxP activities.
Stock List
Tracks inventory consumption and expiry.
Equipment Usage Log
Journals every instrument session.
Grouped by what the lab is doing. Scroll through each area, or jump to a group. Click a screen to look closer — sensitive data is blurred.
Sample to COA · 1 of 4
Opens straight to “what’s waiting for you today” — pending reviews, approvals and sign-offs scoped to the signed-in user’s role.
Sample to COA · 2 of 4
Single system of record for every sample from receipt to certificate — closed-sample dossiers you can audit years later.
Sample to COA · 3 of 4
Branded, variable-driven data-collection forms the analyst fills on-screen, QC reviews on-screen and QA signs on-screen. No paper, no re-transcription.
Sample to COA · 4 of 4
Branded Certificate-of-Analysis templates built once, issued many times — with issue-copy numbering built into the document.
Lab operations · 1 of 4
Live inventory per GRN receipt with expiry tracking, consumption journaling and auto-flagged over-issue conditions.
Lab operations · 2 of 4
Per-use journal of every instrument event — who used what, when, for which sample, in which test. The backbone of the “equipment was ready and ran this test” audit story.
Lab operations · 3 of 4
Documents pushed directly from connected instruments land in the LIMS automatically — no copy-paste, no USB sticks, no gaps in the chain of custody.
Lab operations · 4 of 4
Annual plans for calibration, maintenance, audits, training and renewals — one roof for every recurring GxP activity.
People & access · 1 of 2
Qualify analysts on specific techniques with a documented three-stage lifecycle (Protocol → Run → Report) and a per-technique Pass/Fail record that drives when they must requalify.
People & access · 2 of 2
Lab roles and fine-grained per-action privileges — fully configurable without code changes.
Governance & insight · 1 of 3
End-to-end traceability — every transaction, workflow transition and user action across every module, with CSV and PDF export for inspectors.
Governance & insight · 2 of 3
Draft → Review → Approval governance on every reference record, so test methods, chemicals, columns, equipment and specifications always trace back to who approved them.
Governance & insight · 3 of 3
Prebuilt reports across Sample Management, Materials and Customer Agreements — exportable, printable and filterable per department.
Every step of the quality lifecycle is captured in the same system, by the same roles, in the same audit trail.
Assign role-based training, track compliance and certify GMP competency.
Author, review, approve and distribute SOPs with Part 11 e-signatures.
Move each sample through 9 tracked stages with 4-tier review.
AI extracts batch records and runs an 18-point QA checklist.
Release batches, monitor CPV control charts and generate the APQR.
Track 7 live quality KPIs across products and time ranges.
Electronic records and e-signatures with a complete, tamper-evident audit trail.
Workflows modelled on Good Manufacturing Practice for labs, documents and batch release.
Data that is attributable, legible, contemporaneous, original and accurate — plus complete, consistent, enduring and available.
Supports the pharmaceutical quality system: change control, CAPA, management review and continual improvement.
“Pharma OS digitizes quality workflows and enables faster, reliable batch decisions with AI-assisted documentation, verification, and reporting.”
From lab to batch release — one unified OS for every quality, compliance, and documentation workflow.
Run your pharma quality on one OS.
