Compliance-focused guides to pipetting accuracy and precision (CV%) verification, gravimetric and photometric methods, 96-well and 384-well head qualification, and IQ/OQ/PQ — written for your regulatory framework, whether you run a pharmaceutical GMP operation or a CAP/CLIA clinical laboratory.
Femto Scientific provides preventative maintenance, performance qualification, repair, and IQ/OQ/PQ qualification services for all major automated liquid handling platforms and robotic pipetting workstations. A partial list of systems we service:
Performance verification and preventative maintenance — the standard choice for internal quality programs that do not require formal qualification documentation.
| Service Includes | Level 1 | Level 2 | Level 3 | Level 4 |
|---|---|---|---|---|
| Pipetting Accuracy & Precision Testing | ✔ | ✔ | ✔ | ✔ |
| CV% Testing — All Active Channels | ✔ | ✔ | ✔ | ✔ |
| Preventative Maintenance (PM) | ✔ | ✔ | ✔ | ✔ |
| Cross-Contamination Verification | ✔ | ✔ | ✔ | ✔ |
| Service Report with As-Left Data | – | ✔ | ✔ | ✔ |
| As-Found & As-Left Performance Data | – | – | ✔ | ✔ |
| Installation Qualification (IQ) Protocol | – | – | ✔ | ✔ |
| Operational Qualification (OQ) Protocol | – | – | ✔ | ✔ |
| Performance Qualification (PQ) Protocol | – | – | – | ✔ |
| 21 CFR Part 11 Compliant Documentation | – | – | – | ✔ |
| Options | ||||
|
Express Turnaround
24 hr / 48 hr / 72 hr
|
✔ | ✔ | ✔ | ✔ |
| Onsite Service at Your Facility | ✔ | ✔ | ✔ | ✔ |
| Application-Specific Testing (PCR, NGS, HTS) | ✔ | ✔ | ✔ | ✔ |
| Repair Services | ✔ | ✔ | ✔ | ✔ |
| Consumable Replacement | ✔ | ✔ | ✔ | ✔ |
Level 3 and Level 4 qualification documentation satisfies FDA 21 CFR Part 211, cGMP, GLP, CAP, and CLIA requirements for automated liquid handling systems used in regulated laboratory and pharmaceutical manufacturing environments. Level 4 includes full Performance Qualification (PQ) and 21 CFR Part 11 compliant electronic records documentation.
Automated liquid handling and robotic pipetting systems are deployed across a wide range of laboratory environments. The following highlights common applications by laboratory type — Femto Scientific services automation platforms across all these settings with appropriate qualification and documentation for each compliance environment.
Automated liquid handlers are essential in genomics laboratories for PCR and qPCR setup, RT-PCR workflows, NGS library preparation, DNA and RNA extraction, plate normalization, and serial dilution automation. Robotic pipetting in these applications is evaluated for low-volume accuracy (as low as 0.1 μL), well-to-well consistency, and cross-contamination prevention in 96-well and 384-well formats. Learn about PCR and NGS automation ›
In drug discovery and pharmaceutical research, automated liquid handlers drive high-throughput screening (HTS), compound management, assay development, hit picking, cherry picking, and reagent dispensing automation. These high-volume workflows demand exceptional CV% performance, especially in 384-well and 1536-well plate formats. GMP-compatible qualification documentation is required for applications supporting IND, NDA, or BLA regulatory submissions.
Clinical laboratories under CAP or CLIA accreditation use automated liquid handling for ELISA automation, clinical assay preparation, immunoassay setup, and diagnostic reagent dispensing. Qualification documentation for clinical liquid handling systems must satisfy CAP inspection checklists and CLIA quality system requirements. Femto Scientific provides IQ/OQ/PQ documentation formatted for CAP and CLIA compliance programs.
In regulated cGMP pharmaceutical manufacturing and contract research organizations (CROs), automated liquid handlers support sample preparation, bioanalytical assays, dissolution testing, and formulation workflows. These applications require FDA 21 CFR Part 211-compatible qualification packages with as-found and as-left performance data, full IQ/OQ/PQ protocols, and audit-ready change control documentation.
Femto Scientific’s qualification documentation and service reports meet the requirements of the most demanding regulatory frameworks for automated laboratory systems in pharmaceutical, clinical, and life science environments.
cGMP and GLP programs require automated liquid handling systems to be qualified and maintained with documented performance data, traceability references where applicable, and as-found/as-left records. Femto Scientific’s Level 3 and Level 4 service packages deliver FDA 21 CFR-compatible IQ/OQ/PQ qualification packages suitable for pharmaceutical QC labs, bioanalytical labs, and API manufacturing environments.
Automated liquid handling systems used in FDA-regulated environments are subject to 21 CFR Part 11 requirements when used to generate data supporting regulatory submissions. Femto Scientific’s Level 4 qualification packages include documentation addressing system access controls, audit trail verification, and data integrity review as required by 21 CFR Part 11 and the FDA data integrity guidance.
Clinical laboratories under CAP or CLIA accreditation must document the qualification and performance verification of automated liquid handling systems used in diagnostic testing. Our qualification reports are formatted to satisfy CAP instrument qualification checklists and CLIA quality system regulations, delivered electronically for integration into your LIMS or QMS.
Femto Scientific services all major automated liquid handling systems and robotic pipetting workstations including Hamilton (STAR, VANTAGE, STARlet, NIMBUS), Tecan (Freedom EVO, Fluent), Beckman Coulter (Biomek i5, i7, NX, FX), Opentrons (OT-2, Flex), Gilson (PIPETMAX), Integra (ASSIST PLUS, VIAFLO 96/384), Eppendorf (epMotion series), Formulatrix (MANTIS, FIREFLY), SPT Labtech (mosquito, dragonfly), and many more. Our services include preventative maintenance, performance verification, pipetting accuracy testing, IQ/OQ/PQ qualification, and repair. Contact us if your system is not listed — we service virtually all automated liquid handling platforms.
A standard automated liquid handling system PM visit includes pipetting accuracy and precision testing (CV% across all channels), tip pick-up and ejection verification, cross-contamination testing, mechanical inspection (arm, pipette head, deck alignment), preventative maintenance per manufacturer specification (lubrication, sensor checks, drive inspection), consumable inspection and replacement, software version review, and service documentation with performance data.
Yes. Femto Scientific provides IQ, OQ, and PQ qualification services for automated liquid handling systems in regulated environments. Level 3 includes IQ and OQ protocols; Level 4 adds PQ documentation, 21 CFR Part 11 compliance review, and a validation summary report suitable for GMP and FDA submissions.
Yes. Our Level 4 qualification packages satisfy FDA 21 CFR Part 211 requirements and include IQ/OQ/PQ protocols, as-found and as-left performance data, 21 CFR Part 11 compliance review, and audit-ready documentation for FDA inspections, CAP surveys, and international regulatory audits. We work with your QA team to align documentation with your validation master plan and SOPs.
A 96-well plate has 96 wells in an 8×12 grid (100–300 μL per well); a 384-well plate has 384 wells in a 16×24 grid (10–80 μL per well), providing 4× throughput in the same footprint. 384-well formats are preferred for high-throughput drug discovery screening; 96-well formats are preferred for PCR, NGS library preparation, and ELISA. 384-well liquid handling demands higher pipetting precision due to smaller volumes and closer well spacing.
More questions about automated liquid handling systems?
Our in-depth guide covers all aspects of automated liquid handling — from robotic pipetting technology and 96-well vs 384-well comparisons to PCR automation, NGS workflows, GMP compliance, IQ/OQ/PQ qualification, and 40+ frequently asked questions.
See All FAQs →Femto Scientific provides onsite automated liquid handling system service, qualification, and repair in major laboratory markets across the United States. Our technicians travel fully equipped for all major platforms — no system downtime from shipping, no risk of transit damage.
Remote support, protocol review, and IQ/OQ/PQ documentation services are available nationwide. Contact us to discuss your liquid handling system service requirements.