In sterile production environments, the role of PC systems extends far beyond standard processing power. Ensuring full compliance with GMP standards and safeguarding data integrity are critical elements that underpin operational reliability and regulatory approval. At PSB GmbH, we understand the uncompromising needs of cleanroom and pharmaceutical manufacturing, where every detail affects the outcome. Our engineering team leverages decades of experience to develop and deliver solutions that excel in challenging, contamination-controlled environments. Specialized attention is given to enclosure design, surface finish, and system configuration to minimize contamination risks while ensuring strict adherence to GMP requirements. We work side-by-side with our clients to tailor each system—guaranteeing uninterrupted and data-secure performance throughout the product lifecycle.
Requirements for PCs in Sterile Production Environments
In sterile pharmaceutical manufacturing, strict regulatory compliance is not optional but mandatory. PCs used in these environments—commonly referred to as computer-based systems for sterile production—must meet the highest hygiene and regulatory standards. This applies equally to hardware and supporting software, with a strong focus on the requirements of GMP Annex 11 and GMP Annex 15 governing electronic records and system validation.
Hygienic and Sterile System Design
Hardware must be resistant to contamination and suitable for regular cleaning and sterilization procedures. All devices must withstand approved methods such as moist heat sterilization (EN ISO 10993) and be constructed from materials that do not compromise sterility or promote microbial growth. For example, an IP67-certified computer system (learn more about protected devices) is recommended when high resistance to aggressive cleaning agents and particle ingress is required.
Data Integrity and IT Systems
A core GMP requirement is data integrity. All PCs must ensure that data remains accurate, complete, consistent, and retrievable throughout the entire system lifecycle. Audit trail functionality is mandatory, allowing full traceability of system access and data changes in sterile environments. This includes user access management, electronic signatures, and protection against unauthorized data manipulation. Modern audit trail solutions increasingly incorporate AI-based pattern recognition and anomaly detection to further strengthen data security in pharmaceutical operations.
Additional GMP Requirements
- Risk assessment during system selection and deployment (URS/FS documentation)
- Compliance with D-value criteria for sterilization capability of electronic devices
- Active process monitoring and support for real-time electronic recordkeeping
- Validation of computer-based systems according to defined SOPs
- Documented system scalability and upgrade paths as part of lifecycle management (GMP PC lifecycle)
Selection and Procurement of GMP-Critical PCs
The procurement of a PC for sterile production presents challenges that go far beyond standard office IT deployments. Every step—from initial specification to supplier qualification—must align closely with applicable GMP guidelines.
Checklist: Selecting GMP-Compliant PCs
| Feature | GMP Risk | Minimum Compliance Standard |
|---|---|---|
| Enclosure Rating (IP/IK protection) | Ingress of contaminants, limited cleanability | IP65–IP67, seamless joints (IP67 Computer System) |
| Touchscreen / Keyboard Sanitizability | Microbial growth, cross-contamination | Sterilizable, resistant to alcohol and disinfectants |
| Audit Trail and Logging | Lack of traceability, unverifiable changes | Annex 11 compliant, tamper-proof audit trail |
| Data Integrity Features | Data corruption or manipulation | Automatic backups, role-based access control |
| Validated Operating System | Malware risk, unstable operation | System hardening per SOP, logged updates |
| Supplier Qualification | Compliance gaps, supply chain risks | GMP audit, qualified supplier status (EMC Certified Hardware) |
For applications with limited space or mobility requirements, rugged industrial tablets (read our industrial tablet guide) offer a compliant and flexible alternative.
Supplier Audits and Documentation
Before finalizing procurement, suppliers must undergo a structured audit aligned with GDP and GMP requirements. This audit verifies quality management systems, process control, and experience in regulated environments. Complete documentation—including serial numbers, configuration records, and validation support—is essential to meet Annex 15 expectations.
Validation and Lifecycle Management
The validation of computer-based systems is central to regulatory compliance. GMP Annex 11 and Annex 15 require documented proof that every system used in sterile production is fit for its intended purpose through structured qualification and verification activities.
Standard Operating Procedures (SOPs) and Validation Steps
- User Requirement Specification (URS/FS): Define functional and regulatory requirements, referencing applicable GMP annexes.
- Design Qualification (DQ): Demonstrate that the system design meets all defined requirements.
- Installation Qualification (IQ): Verify correct installation according to vendor and regulatory documentation.
- Operational Qualification (OQ): Test system functionality under normal and boundary conditions.
- Performance Qualification (PQ): Confirm reliable operation in real sterile production workflows without compromising pharmaceutical data integrity.
- System Lifecycle Management: Control the full lifecycle—from maintenance and training to security updates, decommissioning, and secure data archiving.
Download our free SOP template for lifecycle management of sterile production PCs (PDF) to support implementation of these validation steps.
Electronic Signatures and Audit Trail Implementation
Secure and unique electronic signatures compliant with Annex 11 are essential to ensure accountability. Modern systems increasingly integrate AI-driven monitoring to detect vulnerabilities and analyze audit trails for signs of unauthorized access or manipulation.
Practical Implementation and Use Cases
Real-world examples highlight the importance of best practices in sterile production IT. In one pharmaceutical cleanroom, insufficient validation of removable storage policies led to a data integrity incident requiring extensive remediation. By contrast, a medical technology manufacturer using EMC-certified embedded computers benefited from robust hardware that withstood repeated sterilization cycles and enabled tamper-proof logging—resulting in successful regulatory audits without findings.
Interfaces with Other Systems
Efficient operation depends on seamless integration with surrounding infrastructure, including network segmentation, secure server environments, and validated network hardware (see quiet server solutions). Effective change management, rapid incident response, and continuous user training are essential pillars of compliant operations.
GMP-Compliant Process Monitoring
Continuous process monitoring using specialized sensors in combination with validated PCs enables early detection of deviations and complete electronic documentation. These systems must be integrated into the site-wide GMP risk management framework, providing real-time alerts and traceable corrective actions. A validated PC system ensures that every operational step is fully audit-trail documented and readily demonstrable to inspectors.
Future Trends: Automation in Sterile Production
The future of sterile production IT lies in increased automation and the expanded use of artificial intelligence. AI-supported audit trail analysis, predictive maintenance, and advanced anomaly detection are already being adopted in GMP-critical pharmaceutical environments, significantly reducing deviation rates and audit findings. Edge computing—implemented through next-generation industrial PCs and embedded systems (explore EMC embedded computer solutions)—enables local data processing while maintaining GDPR compliance and data integrity.
Standardization and Global Harmonization
Emerging international standards are driving the harmonization of requirements for computer-based systems in sterile production. This trend is expected to streamline validation processes, establish globally recognized audit methodologies, and reinforce full lifecycle management principles (GMP PC lifecycle management) across international markets.
Automation also opens new possibilities for hygienic human-machine interfaces, such as voice-controlled systems for cleanrooms or gesture-based input via sterilizable industrial tablets (discover rugged tablet solutions).
GMP compliance and robust data integrity are non-negotiable foundations for any technology deployed in sterile production. PSB GmbH draws on extensive experience in the development and manufacturing of hardware solutions that reliably meet these stringent requirements, even under demanding conditions. Through rigorous validation, comprehensive burn-in testing, and transparent documentation, we create confidence for both regulatory authorities and end users. By continuously evolving our solutions alongside regulatory and technological developments, PSB GmbH remains a trusted partner for compliant, future-proof sterile production IT infrastructures.
