Femto Scientific delivers IQ/OQ/PQ qualification and performance verification built for FDA 21 CFR Part 211 and 21 CFR Part 11 — gravimetric and photometric verification of volumetric accuracy and precision (CV%) on every robotic pipetting channel, 96-well and 384-well head qualification, and as-found/as-left data, so the Hamilton, Tecan, Beckman, and Opentrons platforms behind your drug-discovery and QC automation pass inspection and your data holds up under audit.
- FDA 21 CFR Part 211 & Part 58 aligned records
- Full IQ/OQ/PQ qualification protocols
- As-found & as-left data for change control
- Volumetric accuracy & CV% at your working volumes
- Gravimetric & photometric verification methods
- 96-well & 384-well pipetting head qualification
- 21 CFR Part 11 electronic-records review
- Onsite service with zero shipping downtime
Accredited liquid handling qualification your quality unit can defend against a data-integrity finding.
Why GMP Laboratories Require IQ/OQ/PQ Qualification for Automated Liquid Handling
In a cGMP environment, every robotic liquid handler is a measuring system whose volumetric accuracy and precision flow directly into assay results, batch records, and release decisions. FDA 21 CFR Part 211 sets the equipment-qualification expectations; formal IQ/OQ/PQ with gravimetric and photometric verification provides the documented performance evidence and 21 CFR Part 11 data integrity that prove the system can actually demonstrate compliance.
FDA 21 CFR Part 211 & Part 58
Equipment used in drug manufacturing and testing must be qualified and maintained on a written schedule with limits, results, and remedial action recorded. Our IQ/OQ/PQ packages capture the qualification date, results, acceptance criteria, and as-found/as-left data your quality unit needs for Part 211 cGMP and Part 58 GLP programs.
Volumetric Accuracy & CV% Verification
We verify volume accuracy and coefficient of variation (CV%) on every active channel across your working volume range using gravimetric (ISO 8655-style) and photometric methods — the precision evidence auditors expect for 96-well and 384-well pipetting heads and low-volume drug-discovery workflows.
21 CFR Part 11 & Data Integrity
Automated liquid handling software that generates data supporting regulatory submissions falls under 21 CFR Part 11. Our Level 4 qualification includes an access-control, audit-trail, and electronic-records review, giving you the attributable, accurate, contemporaneous evidence expected under ALCOA+ and the FDA data-integrity guidance.
A Complete, Documented IQ/OQ/PQ Qualification
Every accredited qualification characterizes performance across your actual working volumes and plate formats — not just a single volume — and records as-found data so an out-of-tolerance channel can be impact-assessed under change control.
- Volumetric accuracy & precision (CV%) per channel
- Gravimetric & photometric verification methods
- 96-well & 384-well head qualification
- As-found & as-left data with adjustment
- Cross-contamination & tip pick-up verification
- 21 CFR Part 11 electronic-records review
Compare service levels and documentation on the automated liquid handling service page, or see our pipette calibration service for the single- and multi-channel pipettes your automation program depends on.
Pharmaceutical & GMP Automated Liquid Handling FAQs
Automated liquid handling systems are not inherently GMP compliant — they must be qualified, maintained, and operated according to GMP requirements to be used in a GMP environment. GMP compliance for liquid handling systems requires formal IQ/OQ/PQ qualification documentation, a written equipment maintenance and calibration schedule, documented change control procedures, trained operators with documented training records, and electronic records management compliant with 21 CFR Part 11 if applicable. Femto Scientific’s Level 4 qualification service delivers the complete GMP-compatible qualification package.
IQ/OQ/PQ is the qualification framework for laboratory equipment in regulated environments. IQ (Installation Qualification) confirms the system is installed correctly per specifications. OQ (Operational Qualification) verifies the system operates within defined performance parameters (volume accuracy, CV%, cross-contamination). PQ (Performance Qualification) confirms the system consistently performs to user requirements under actual conditions. All three phases are required for automated liquid handling systems in GMP, GLP, and FDA-regulated laboratory environments.
Femto Scientific’s IQ/OQ/PQ qualification documentation includes executed IQ/OQ/PQ protocols with acceptance criteria, as-found and as-left performance data, deviation reports for any out-of-specification findings, corrective actions taken, technician signatures and date/time records, reference instrument calibration certificates, and a qualification summary report. Level 4 additionally includes a 21 CFR Part 11 compliance review and a validation summary report formatted for FDA submissions and QMS integration.
21 CFR Part 11 (Electronic Records; Electronic Signatures) requires that computerized systems used in FDA-regulated environments maintain electronic records with audit trails, use controls to ensure authenticity and integrity of data, restrict system access to authorized users only, and provide the ability to generate accurate, complete copies of records. For automated liquid handling systems, this means the liquid handling software must log every protocol execution with operator ID, date/time, and key parameters in a tamper-evident format. System validation documentation must confirm that these controls are implemented and functioning.
CV% (coefficient of variation) is the standard deviation of repeated volume measurements divided by the mean volume, expressed as a percentage. It quantifies pipetting precision (consistency). A CV% of 1% means the standard deviation of dispensed volume equals 1% of the target volume. For most automated liquid handling applications, ≤5% CV is acceptable; for 384-well and low-volume work, ≤2% CV is preferred. CV% increases at lower volumes and is the primary metric used in liquid handling system performance qualification.
Put Your Liquid Handlers on a Defensible GMP Qualification Program
Tell us your platform, channel count, and required service level — we’ll return a quote with turnaround options and a recommended re-qualification interval for your compliance program.