🔬 Chemical & Pharma ERP: Quality control
Plan samples, test against versioned specifications, catch out-of-specification results the moment they're entered, run ICH stability studies and release batches with a certificate built from approved data.
Move the slider for the number of containers received. A common plan samples the square root of the count plus one, picked at random so no container is favoured. Your own plan can differ by material or supplier.
Batch B-2410 against its specification. Each bar shows where the result sits inside the allowed range. Demo data.
Approved results become the certificate of analysis, signed electronically. Nobody retypes a value.
Batch B-2411's dissolution came in at 74% against a limit of 80%. Choose what the lab check finds and follow the path.
Did the lab check find an assignable error?
Pick a storage condition. Each dot is a pull point from the protocol. The dashed line is a simple trend, and the red line is the 95% assay limit. Demo data; real shelf life is set with the statistics in ICH Q1E.
Assay for the last 25 batches, with the mean and control limits at three standard deviations. Turn on a rule to see which batches it flags. Demo data.
What each one asks of QC, and where it's handled in the suite.
Nine capabilities, each linked to the related module or service.
Send us one specification and a recent CoA. We'll show the full sample-to-release flow on your own data.
See my specs in a demoSee the Chemical & Pharma ERPSix steps to bring QC onto one system.
What changes once the lab runs on one system.
Results, CoA and release move without paper.
Limits are checked as results come in.
Stability pull dates arrive as tasks, on time.
Every result has its raw data and audit trail.
From a single plant QC lab to contract testing labs.
One integrated system.
Industries and services connected to quality control.
Answers for QC heads, QA managers and lab teams.
It runs the QC lab: sampling plans, specifications, test worksheets, results from instruments, OOS investigations, stability studies, certificates of analysis and batch release, with an audit trail on every result.
It covers the core of a LIMS for manufacturing QC, inside the ERP, so results link straight to batches, materials and release. If you already run a LIMS or chromatography data system, we can connect to it instead.
A result outside the specification opens an OOS record straight away. It follows a phased investigation: a lab check, then hypothesis testing with a written retest plan, then a full-scale investigation if needed, in line with FDA's OOS guidance. The batch stays on hold until QA closes it.
Yes. Protocols set the conditions, such as 30 °C / 75% RH for zone IVb, which includes India, and the pull points. Pulls arrive as tasks, results are trended, and out-of-trend values are flagged.
Your sampling plan decides. A common rule for incoming containers is the square root of the number of containers plus one, and the system can apply different plans by material, supplier history or risk.
Yes. Once results are reviewed and approved, the CoA is generated from them and signed electronically. Nobody retypes a result.
Yes: unique logins, e-signatures linked to records, audit trails and access control. Your validation and procedures complete the picture.
Yes. Results and raw data can come from chromatography data systems, balances, dissolution testers and other instruments, through files or direct integration.
As an estimate, 8 to 12 weeks for one QC lab, including validation. It depends on the number of specifications and instruments to connect.
Tell us your products, instruments and how your QC lab works today. We reply within 4 business hours and can demo with one of your own specifications.