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- 2026-05-06
- 11:35
Designing a Validation-Ready Precision Dispensing Workstation: What Regulated Industries Need To Get Right
Good Manufacturing Practice (GMP) and related validation guidelines form the backbone of regulated industries such as pharmaceuticals or In Vitro Diagnostics (IVD). They establish global standards to ensure that products are consistently developed and manufactured safely, effectively, and of high quality.
Vendors must support regulated industries with steady equipment performance, full traceability, and comprehensive documentation to enable consistent output and minimize the risk of equipment failure.
The foundation for validation-ready equipment is laid early during the product’s design phase. In particular, the User Requirements Specification (URS) plays a central role in defining what a system must achieve and how it will support downstream validation. In this article, we outline the core elements of validation-ready manufacturing with a special focus on what equipment suppliers need to get right. We explain why the URS is critical for both equipment suppliers and manufacturers and share practical guidance on what it should include and who should be involved.
Core elements of a regulated manufacturing environment
Quality Assurance and Regulatory Affairs (QARA) managers in collaboration with other stakeholders, are responsible for ensuring compliance, minimizing risk, and maintaining audit readiness, which directly influences their evaluation of new solutions.
To understand what equipment vendors need to provide to meet the high standards of regulated industries, we next examine the core elements of regulated manufacturing.
Quality Management System (QMS)
A robust QMS is the framework for compliant manufacturing. It includes policies, procedures, and guidelines covering production, quality control, and distribution, with a strong focus on continuous improvement.
Facility and Equipment Design
Facilities and equipment must prevent contamination, support efficient workflows, and allow easy cleaning and maintenance. Regular validation and preventive maintenance ensure consistent performance.
Personnel training and Competency
Regular, comprehensive training ensures all personnel are qualified for their roles and understand their responsibilities in GMP-regulated environments.
Product Testing and Release
In-process controls and final product testing ensure consistent quality and support batch release decisions.
SOPs and Process Control
Clear, detailed Standard Operating Procedures (SOPs) define task execution and control. SOPs must be regularly reviewed, updated, and consistently followed by trained personnel.
Change and Deviation Management
Any deviations or changes must be documented, investigated, and addressed through corrective and preventive actions (CAPA) to avoid recurrence (Corrective and Preventive Actions (CAPA) | FDA, n.d.).
Risk management
Risk assessment and mitigation are integral to quality manufacturing. While Medical Device and IVDR manufacturers primarily apply the ISO 14971 risk management system, required tobe implemented within the ISO 13485 quality management system, equipment suppliers must maintain a broader risk management approach.
Data integrity and Security
Electronic data must be protected in accordance with regulatory requirements, such as 21 CFR Part 11 and EU GMP Annex 11, to ensure data accuracy, integrity, and traceability.
Documentation and traceability
Accurate, complete, and traceable documentation supports audits and demonstrates regulatory compliance throughout the product lifecycle. Documentation should be structured to map clearly to the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases. For example, each document or record should indicate which qualification phase it supports, such as design specifications and certificates supporting IQ, calibration and training records for OQ, and performance data for PQ.
From Vision to Validation: Why the URS is the Foundation of a Quality-Driven Dispensing Station
Having outlined the core components of validation-ready manufacturing that suppliers must provide, we now turn to the URS, which is essential for designing products that meet the expectations of regulated industries. It is not only a technical document, but also a cornerstone of traceability and control during audits.
The URS:
- Translates user needs into clearly documented requirements
- Guides system design and vendor evaluation
- Forms the basis for qualification and validation (IQ/OQ/PQ)
- Ensures alignment between users, suppliers, quality, and regulatory teams
Five Tips for Designing a Validation-ready Precision Dispensing Workstation
Involve the Right Stakeholders Early
Engage operators, engineers, quality assurance, and regulatory experts early in the requirements definition process. Each group contributes essential perspectives that strengthen the URS. Collaboration begins with joint meetings to identify user needs and continues through iterative review cycles, where teams refine requirements and address challenges. Share draft URS documents for feedback and use discussions to clarify technical and compliance priorities, fostering open communication.
Clearly Define All Requirements
A complete URS should include:
- Functional requirements: accuracy, precision, sensitivity, volume range
- Non-functional requirements: usability, reliability, scalability, performance
- System integration: connectivity with existing IT or automation systems
- Safety, maintenance, and calibration requirements
- User interface and training needs
Incorporate Applicable Regulatory Frameworks
Ensure all specifications align with relevant standards, including:
- ISO 13485 – Quality management for medical devices (widely used by IVD manufacturers)
- EU IVDR (2017/746) – European regulation for IVDs, requiring extensive documentation, traceability, and risk management
- FDA 21 CFR Part 820 – US Quality System Regulation, now aligned with ISO 13485
- 21 CFR Part 11 – Electronic records and signatures, critical for instrument software and data handling
- GMP / cGMP (EU Annexes 1 and 11; FDA 21 CFR Parts 210–211) – Relevant for pharmaceutical manufacturing environments
Build in Controls and Documentation
Systems should maintain data integrity by logging key parameters such as dispense volume, speed, timing, operator ID, and quality control data.
Define Validation Criteria Early
Review and align acceptance criteria for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) during the design phase to prevent delays. Suppliers should provide complete validation documentation packages, make technical data and certificates of conformity available, offer validation plan templates and guidance, and support customers with onsite or remote assistance during equipment qualification.
Case Study Spotlight: SCIENION's Automated Equipment for Quality Dispensing
This section provides an example URS for SCIENION’s sciFLEXARRAYER Precision Dispenser designed for miniaturized ELISA applications. In this specific sample, the customer wanted to transition from traditional low-throughput semi-automated pipetting, which dispenses microliter volumes and results in high antibody costs, plate-to-plate variability, and significant dead-volume losses, to a miniaturized, automated platform capable of dispensing picoliter to nanoliter droplets. The proposed sciFLEXARRAYER dispensing systems aims to enable high-throughput, multiplexed ELISA or microarray assays with improved reproducibility and significantly reduced consumable costs.
The proposed system uses a non-contact dispense module to deliver capture and detection antibodies and standards in picoliter volumes into microarrays within each well of a 96-well plate. It includes environmental controls for humidity and evaporation, a deck for both source and destination plates, barcode and 2D-code readers for precise sample tracking, and a plate hotel or stacker for automated processing. The software features an intuitive HMI that enables users to import plate maps, assign dispensing methods, and track dispense events at the individual well or spot level.
In the table below, the URS system requirements are listed in more detail, with responsibilities assigned to stakeholders to ensure accountability and traceability.
| Section | Description | Case study | Responsible stakeholder |
|---|---|---|---|
| Business requirements | Key project objectives plus documentation, staffing, and OEE expectations. | Cut antibody consumption by ≥80% by moving from 1 – 5 µL additions to 0.2 – 1.0 nL droplets, support ≥200 plates/day (96-well equivalent) with automated plate handling, enable unattended operation (≥4 hr) with ≥90% run success and clear changeover/cleaning SOPs. | Project Manager, Assay Scientist (End User), Automation Engineer, Finance/Procurement |
| Data management requirements | Secure network integration, interfaces, and batch reporting expectations. | Pull plate and well maps and reagent IDs from LIMS, write back a Part-11-ready run report including method/version, operator, timestamps, barcodes, commanded vs. measured volume, exceptions, and audit trail, export CSV/JSON and retain logs per policy. | IT/Automation Lead, Automation Engineer, QA Lead, Validation/CSV Lead, Project Manager |
| Process requirements | General process needs, cleaning requirements, inputs, steps, and outputs. | Dispense capture antibody (or antigen) in defined spot patterns or full-well additions at 200 – 1000 pL; minimize carryover via non-contact transfer, controlled wash/prime cycles, and validated liquid classes for PBS/BSA buffers. | Process Development Scientist, Automation Engineer, QA Lead, Project Manager |
| Operational requirements | Operating modes, access control, HMI, alarms, and system behaviors. | Role-based access (Scientist/Supervisor/Admin), guided setup via plate maps, automated prime/purge, nozzle health checks, pause/resume with plate protection, remote monitoring, and defined recovery rules for missed wells/spots. | Automation Engineer, IT/Automation Lead, QA Lead, Project Manager |
| Product quality requirements | In-process QC expectations and pass/fail handling. | Verify dispense accuracy/precision using high-resolution camera; acceptance criteria (≤10% CV at 500 pL, ≤5% at 1 nL); enforce controls and trigger re-dispense, quarantine, and deviation logging when out of tolerance. | QA Lead, Process Development Scientist, Validation/CSV Lead, Project Manager |
| Project / engineering / qualification | Scheduling, change control, engineering standards, and qualification milestones. | FAT/SAT to confirm droplet volume, plate registration, barcode integrity, audit trail, and exception handling; IQ/OQ with calibrated standards; PQ using ≥3 ELISAs demonstrating consistent curves, CV, and performance across days/operators. | Validation/CSV Lead, QA Lead, Automation Engineer, Project Manager |
Conclusion
Designing a validation-ready precision dispensing workstation requires a holistic approach that goes far beyond achieving technical performance specifications. In regulated industries such as pharmaceuticals and IVD, equipment must operate within a tightly controlled ecosystem, contributing to validated processes that directly impact product safety, efficacy, and regulatory approval.
At the core of any project lies the User Requirements Specification (URS), which serves as the critical bridge between user needs, engineering design, and regulatory expectations. A well-developed URS ensures that all stakeholders, from end users and automation engineers to QARA managers and validation teams, are aligned from the outset. As highlighted throughout this article, the URS is not a static document but a living framework that guides the system’s lifecycle from concept to manufacturing.
Equally important is integrating GMP principles into every stage of equipment design. A validation-ready dispensing workstation must embed compliance into its architecture: from data integrity and audit trails to controlled workflows, reproducible performance, and seamless documentation.
The sciFLEXARRAYER case study illustrates how these principles translate into real-world impact. By combining non-contact precision dispensing with automation, environmental control, and robust data handling, the system consistently delivers reliable results, provides complete visibility into its processes, and enables users to maintain control over quality and compliance at every step.
For equipment suppliers, this represents both a challenge and an opportunity. The challenge lies in understanding the complex regulatory landscape and translating it into practical, user-friendly solutions. The opportunity, however, is significant: suppliers who can deliver validation-ready, application-focused, and fully documented systems position themselves as trusted partners rather than transactional vendors.
Learn more about SCIENION’s Validation-Ready Dispensing Instruments: Custom Solutions – SCIENION
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