The Problem: IT Security as an Accreditation Barrier
Research laboratories seeking accreditation according to the ISO/IEC 17025:2018 standard face a serious challenge: how to document information system security?
Auditors from PCA (Polish Centre for Accreditation) ask:
- "Are the data protected against unauthorized access?"
- "How do you ensure the integrity of test results?"
- "Where are backups stored?"
- "Who has access to the system and on what basis?"
- "How do you respond to security incidents?"
Typical reaction from laboratory managers: "These are questions for the software provider, right?"
The Problem:
Many laboratories implement a LIMS system without an appropriate service agreement that defines security principles. As a result, during an accreditation audit, they are unable to present documentation confirming compliance with standard requirements.
The Solution: Professional Service Agreement as Security Foundation
Key Information:
A well-prepared service agreement with a LIMS system provider automatically covers approximately 70% of security requirements set by the ISO/IEC 17025 standard.
Why? Because most security measures lie on the infrastructure and system management side – areas for which the software provider is responsible.
Let's look at how this works in practice using the example of the CleverLAB system.
10 Key Security Areas Covered by the Service Agreement
1. Server Infrastructure with ISO 27001 Certification
Auditor's Requirement:
"Where is our data stored? Is the data center secure?"
What the provider ensures:
- Professional data center with ISO 27001 certificate
- Tier III standard or higher (99.982% availability)
- Physical security: 24/7 monitoring, biometric access control
- Fire suppression systems and precision air conditioning
- Redundant internet connections
Benefit for the laboratory: You don't need to invest in your own server room or worry about the physical security of infrastructure. It's enough to document that the provider has the appropriate certificates.
2. Data Encryption at Every Level
Auditor's Requirement:
"How is data protected during transmission and storage?"
What the provider ensures:
- Transmission encryption: SSL/TLS certificate (HTTPS protocol)
- Password encryption: bcrypt or SHA-256 algorithms
- Backup encryption: All backups encrypted
- Data in the EU: GDPR compliance
3. Automatic Backups with Tested Recovery Procedures
Auditor's Requirement:
"What happens if the server fails? Is the data safe?"
What the provider ensures:
- Daily backups of the database (automatic)
- Weekly backups stored for 3 months
- Monthly backups stored for 1 year
- Geographic separation: Backups in a separate location
- Regular tests of data recovery procedures
- Encryption of all backups
Benefit: You don't need to remember to make backups or worry about data loss. The system is secured at a corporate level.
4. RBAC Permission System – Who Sees What?
Auditor's Requirement:
"How do you control access to sensitive data?"
What the CleverLAB system ensures:
- Role-Based Access Control (RBAC) – role-based permissions
- Individual permissions (e.g., "add sample", "edit result", "authorize report")
- Permission groups (e.g., "Laboratory Technician", "Manager", "Administrator")
- Data separation between clients
- Immediate deactivation of employee accounts
Typical roles in a laboratory:
- Administrator – full access to system configuration
- Laboratory Manager – management, reports, approvals
- Analyst – entering and viewing results
- Authorizer – authorization of test reports
- Viewer – read-only access
5. Complete Audit Trail – Who, When, What Changed
Auditor's Requirement:
"Can you show the history of changes in test results?"
What the system ensures:
- Logging of all logins and logouts
- Recording of failed login attempts
- Tracking changes in critical data (test results, certificates)
- Logging of administrative operations
- Metadata for each record: created_by, created_date, verified_by, verified_date
Log retention:
- Minimum 2 years (or according to accreditation requirements)
- Protected against modification
- Ability to generate reports for auditors
6. Password Policy According to Best Practices
What the system enforces:
- Minimum length: 8 characters
- Complexity: letters, numbers, special characters
- No repetitions: Cannot use recent passwords
- Automatic lockout after a specified number of failed attempts
- Automatic logout after a period of inactivity
7. 24/7 Monitoring and Incident Response
What the provider ensures:
- 24/7 monitoring of system availability
- Automatic alerts for anomalies
- Vulnerability scanning
- Incident handling procedure with notification within 24 hours
- Documentation of every incident with root cause analysis
8. GDPR Compliance and Personal Data Protection
What the provider ensures:
- Data processing agreement (required by GDPR)
- Data stored on servers in the EU
- Procedures for exercising individual rights (right to erasure, correction, etc.)
- Register of processing activities
- Data breach notification procedures
9. Regular Security Updates
What the provider ensures:
- Regular updates of the operating system and software
- Critical patches deployed as a priority
- Testing before production deployment
- Informing clients about planned maintenance work
10. SLA and Guaranteed Availability
What the service agreement ensures:
- Guaranteed availability (SLA): typically 99.5% or more
- Recovery Time Objective (RTO): to be agreed (e.g., 4 hours)
- Recovery Point Objective (RPO): to be agreed (e.g., maximum 24 hours of data loss)
- Helpdesk available during business hours
- Emergency contact according to SLA agreement
What Remains to be Done on the Laboratory's Side? (30% of Requirements)
Although the service agreement covers most technical requirements, the laboratory is still responsible for:
1. User Management
- Creating and deactivating employee accounts
- Assigning appropriate roles and permissions
- Regular verification of active user list
2. Organizational Policies
- Procedure for granting system access
- Laboratory security policy
- Employee training in system operation
3. Documentation
- User instructions
- Procedures for handling failures
- Defining responsible persons (System Administrator)
4. Local Monitoring
- Tracking unusual user behavior
- Reporting incidents to the provider
- Cooperation during internal audits
How It Works in Practice – Case Study
Microbiology laboratory, 15 employees, applying for PCA accreditation
| Aspect | Before CleverLAB | After CleverLAB |
|---|---|---|
| System | Excel + paper documentation | LIMS system with complete documentation |
| Change logs | None | Complete audit trail |
| Access control | Everyone has access to everything | RBAC permission system |
| Backups | Manual, irregular | Automatic, daily |
| Documentation preparation time | 2-3 months | 2 days |
| Security documentation cost | 15,000 - 30,000 PLN | 0 PLN (included) |
| PCA auditor's assessment | "System unacceptable" | "Meets all requirements" |
Service Agreement as a Competitive Advantage
A professional service agreement is not just an accreditation requirement – it's a guarantee of laboratory business continuity.
What Should a Good Service Agreement Contain?
- Detailed description of infrastructure (hosting, certificates, backup)
- Guaranteed availability (SLA)
- Security procedures (encryption, access control, monitoring)
- Incident management (response time, escalation)
- GDPR compliance (data processing agreement)
- Technical support (helpdesk, response time)
- Security updates (schedule, testing)
- Responsibility structure (who is responsible for what)
CleverLAB and Comprehensive Security
The CleverLAB system was designed with ISO/IEC 17025:2018 standard requirements in mind. Already in the standard implementation agreement, you receive:
This means you can present complete system security documentation to the auditor on the first day after implementation.
Additional Services: IT Security Audits in Laboratories
In addition to the standard service agreement, we also offer:
🔍 Laboratory IT Security Audit
- Assessment of current security status
- Identification of gaps and threats
- Recommendations tailored to accreditation requirements
- Report for PCA auditor
🔍 Accreditation Audit Preparation
- Verification of security documentation
- Simulation of auditor's questions
- Personnel training in system security
🔍 Penetration Testing (Optional)
- Testing system resilience to attacks
- Report on detected vulnerabilities
- Corrective action plan
Summary: Security Doesn't Have to Be Expensive or Complicated
Key Conclusions:
- 70% of security requirements for accreditation are met by a professional service agreement with a LIMS provider
- You don't need to be an IT expert to implement a secure system – the provider delivers ready infrastructure and documentation
- Security documentation cost: 0 PLN (included) vs. 15,000 - 30,000 PLN (external expertise)
- Preparation time: 2 days (verification) vs. 2-3 months (creating from scratch)
- Service agreement is an investment, not a cost – it ensures business continuity and standard compliance
Want to Learn More?
We can discuss each of the 10 security areas in detail at a meeting or in a dedicated PDF document
Individual topics require detailed explanations and arrangements. We also offer IT security audits for laboratory systems.
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About the Author
This article was created based on many years of experience in designing LIMS systems for accredited laboratories. Our team combines IT security expertise with practical knowledge of ISO/IEC 17025 standard requirements.
We have conducted dozens of IT security audits in laboratories and supported many laboratories in the process of obtaining and maintaining PCA accreditation.
Key Takeaway
You don't need to be a cybersecurity expert to meet accreditation requirements. A well-prepared service agreement with a LIMS system provider automatically provides professional security at a corporate level – for a fraction of the cost of hiring an IT specialist or building your own infrastructure.