Software & Hardware Qualification · Compliant and traceable control systems for GMP environments

The validation of software and hardware control systems is a key aspect of ensuring compliance, traceability, and data integrity in automated pharmaceutical and radiopharmaceutical processes.

Depending on project requirements, Comecer provides qualification activities aligned with internationally recognized guidelines and regulations. These activities are integrated into the system development lifecycle, ensuring that automation is designed, tested, and documented according to GMP expectations.

GAMP® 5 Compliance

Lifecycle-based validation of automated systems

Where required, Comecer develops automation systems in alignment with GAMP 5 Guide for Validation of Automated Systems, applying a structured lifecycle approach to design, development, and validation.

This approach ensures that all system functionalities are clearly defined, implemented, and verified through documented specifications and test protocols.

The lifecycle documentation typically includes:

• FDS (Functional Design Specification), describing system functions and user requirements
• HDS (Hardware Design Specification), defining hardware architecture and components
• STS (Software Test Specifications), detailing software validation tests
• HTS (Hardware Test Specifications), covering hardware verification activities

In addition, a formal change control process is applied throughout the project lifecycle, ensuring that any modification is evaluated, documented, and validated in a controlled manner.

FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures)

Software compliance with FDA 21 CFR Part 11 is ensured through a documented assessment of regulatory requirements and their implementation within the software development lifecycle. Comecer defines how these requirements are applied, including controls for electronic records, user access, audit trails, and electronic signatures.

Compliance is verified through validation activities, including Software Test Specifications (STS), which confirm that the system operates in accordance with defined requirements and applicable regulations.