How to Validate Weighing Software Under GAMP 5 and IEC 62304

Software validation is a critical requirement in regulated industries such as pharmaceuticals, biotechnology, and medical devices. In weighing systems, validation ensures that electronic records, control logic, and digital outputs comply with international standards for safety, accuracy, and data integrity. Two of the most widely recognized frameworks are GAMP 5 (Good Automated Manufacturing Practice) and IEC 62304 for medical software lifecycle management.

Why Software Validation Matters

Validated weighing software guarantees that all measurement processes perform consistently, accurately, and traceably. It protects users from errors caused by software faults, incorrect configurations, or cybersecurity vulnerabilities. Regulatory bodies such as the FDA and EMA require documented proof that weighing software meets its intended use and operates under controlled conditions.

Compliance: Meets regulatory requirements such as 21 CFR Part 11, EU Annex 11, and ISO 17025.
Traceability: Links every function to a verified requirement and test record.
Risk Mitigation: Identifies and controls software-related process risks.
Audit Readiness: Provides evidence for authorities and customers.

Understanding GAMP 5

GAMP 5 defines a risk-based approach for validating automated systems used in GxP-regulated environments. It categorizes software and guides users through lifecycle management, from specification to decommissioning.

Category 1: Infrastructure software (e.g., OS, database).
Category 3: Non-configured products such as standard weighing indicators.
Category 4: Configured systems — weighing software customized for specific processes.
Category 5: Bespoke systems — custom applications or weighing algorithms.

Validation under GAMP 5 focuses on documented control rather than testing alone. This includes requirement traceability, supplier assessment, configuration management, and change control.

IEC 62304: Software Lifecycle for Medical Weighing Systems

IEC 62304 establishes the framework for developing and maintaining medical device software. It applies to hospital and clinical weighing systems that directly influence patient care.

Lifecycle Approach: Defines development, maintenance, risk management, and configuration processes.
Software Safety Classes: Class A (no injury risk), B (non-serious injury possible), C (serious injury or death possible).
Documentation Requirements: Each class demands increasing levels of verification and testing.
Integration: Works alongside ISO 14971 (risk management) and IEC 62366 (usability engineering).

Key Validation Activities

User Requirements Specification (URS): Define what the software must do and under what conditions.
Functional Specification (FS): Describe the technical functions and interactions.
Risk Assessment: Identify hazards associated with software operation and data handling.
Verification & Testing: Confirm that every requirement is implemented and functions correctly.
Validation Report: Summarize all evidence and confirm that the system is fit for use.

Weighing Software Components That Require Validation

Calibration Modules: Ensure accuracy and traceability in digital calibration processes (digital certificates).
Batch and Recipe Software: Validates correct dosing, sequencing, and weighing tolerances.
Data Transmission Interfaces: Secures communication between terminals, PLCs, and MES/ERP systems (secure transmission).
User Management: Validates access levels, audit trails, and change logs.

Electronic Records and Signatures

For systems subject to FDA 21 CFR Part 11 or EU Annex 11, electronic data integrity must be proven. This includes audit trails, version control, and validated export functions.

Audit Trails: Record every action that affects weighing results.
Electronic Signatures: Must be unique, secure, and non-transferable.
Time Synchronization: Ensures event timestamps remain accurate and traceable.
Data Encryption: Protects sensitive measurement data at rest and in transit.

Maintaining Compliance Over Time

Change Control: Every software update must be assessed and revalidated as needed.
Periodic Review: Confirms system operation remains within validated parameters.
Supplier Audits: Ensure third-party software providers comply with GAMP 5 principles.
Training: Operators and administrators must be trained and documented.

Best Practices for GAMP 5 / IEC 62304 Validation

Define clear user requirements and maintain a traceability matrix.
Apply a risk-based approach — more effort where risk to quality or safety is higher.
Validate in the intended operational environment.
Automate testing and documentation where possible.
Maintain validation packages for audits and re-certification.

Future Outlook

Emerging AI-driven weighing systems will require new validation models. Regulators are beginning to address adaptive algorithms that modify behavior through machine learning. Future guidance may integrate generative AI in documentation and AI-based anomaly detection within GAMP 5 frameworks, ensuring both innovation and compliance.