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 manufactuing 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
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
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
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
Each URS requirement is assigned to responsible stakeholders, ensuring accountability and traceability throughout the project. Solution providers like SCIENION involve all relevant internal teams, including engineering, quality management, and operations, to support URS development and act as partners. Collaboration starts with joint customer meetings to identify user needs and continues through iterative review cycles where both teams refine requirements and address challenges. Draft URS documents are shared for feedback, and discussions clarify technical and compliance priorities, promoting open communication. This partnership ensures the final URS meets customer needs and regulatory requirements, resulting in a robust, validation-ready dispensing solution.
Here is a case study for an automated dispensing system involving different stakeholders within the company:
| Section | Description | Case study | Responsible stakeholder |
|---|---|---|---|
| Introduction | Confidentiality, purpose, scope, acronyms/definitions, high-level system overview and proposed process. | Non-contact piezo jet liquid dispensing system for miniaturized ELISA, dispensing capture/detection antibodies and standards in 200–1000 pL droplets into microarrays within each well of a 96-well plate to enable reagent-sparing, high-throughput immunoassays. | Project Manager, Quality Assurance (QA) Lead, Validation/CSV Lead, Assay Scientist (End User) |
| Background | Product overview, current process/equipment, process flow, and labor utilization assumptions. | Current ELISA setup uses low-throughput pipetting (µL volumes) with high antibody cost, plate-to-plate variability, and dead volume losses. Goal is to miniaturize to pL – nL dispensing for multiplexed ELISA/microarray formats with improved reproducibility and lower consumable spend. | Project Manager, Process Development Scientist, Assay Scientist (End User), Quality Assurance (QA) Lead |
| Project Overview | Brief description of the system and its purpose | Non-contact dispense module with humidity/evaporation control, deck for source/destination plates, barcode/2D-code readers, plate hotel/stacker for walk-away runs, and software (HMI) to import plate maps, assign methods, and track dispense events at well/spot level. | Project Manager, Automation Engineer, IT/Automation Lead, Facilities & EHS Engineer |
| 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
Equipment vendors need to take extra care and apply specific quality policies to be considered as a solutions provider for regulated manufacturing environments. The URS is the backbone of any successful GMP project. Investing the time and expertise to develop a clear, comprehensive URS for a precision dispensing workstation pays off in smoother validation, stronger compliance, and long-term operational efficiency.