The IT Odyssey of a Lab Head
Written by Julian Meunier & Dominic Lütjohann
It all began with a seemingly straightforward request:
“We need to validate a new quality control analytical method for DNA analysis.”
Dr. D., the Lab Head, immediately thought of the DNA-Saur, an instrument stored in the basement since a previous proof-of-concept initiative. At that time, only high-level requirements had been defined, and initial steps were taken to explore the experimental setup.
The device, which comes with its control and analysis software, appeared to fit the purpose perfectly. Shortly thereafter, management issued a directive:
“The instrument must be implemented by the end of the quarter. It is already available and was connected before—just set it up and start. Let’s not waste time or resources.”
What sounded like a simple technical task soon revealed itself as a complex compliance and integration challenge.
Initial Step: Vendor Engagement
The first logical action for Dr. D. was to contact the vendor. Their response was efficient: documentation packages including certificates, IQ/OQ protocols, and user manuals were provided, along with an assurance of technical support availability.
Initially, this seemed sufficient. However, critical questions quickly emerged in his mind:
- Does the vendor documentation fully address regulatory requirements?
- Are the provided IQ/OQ protocols aligned with internal compliance standards?
- Who is authorized to execute these protocols under established SOPs?
It became clear that vendor documentation is only the foundation of a compliant implementation. In a regulated environment, validation requires a structured, risk-based approach supported by governance and traceability.
This realization marked the transition from a perceived technical task to a formal compliance-driven project.
Checkpoint 1: Quality Assurance – The Compliance Authority
The involvement of Quality Assurance (QA) introduced a new dimension of complexity. In a GxP-regulated environment, instrument integration is governed by strict frameworks such as 21CFR and eudralex volume 4.
QA asked Dr. D. for a change request to define the validation strategy, forming the basis for all subsequent activities. The following steps were essential:
Regulatory Classification and Risk Assessment
The system was classified according to USP 1058 standards, and a comprehensive risk assessment was conducted to identify potential impacts on data integrity and product quality. This assessment defined the depth and rigor of validation activities.
Documentation Framework
QA required a structured documentation package, including:
- User Requirement Specification (URS) outlining the intended use, user and functional expectations.
- Validation Plan detailing IQ/OQ/PQ protocols and responsibilities.
- Standard Operating Procedures (SOPs) for operation, maintenance, and data handling.
Qualification Execution
The instrument underwent formal qualification:
- Installation Qualification (IQ) to confirm correct installation.
- Operational Qualification (OQ) to verify functionality under controlled conditions.
- Performance Qualification (PQ) to demonstrate consistent performance in routine use.
Data Integrity Controls
Audit trail functionality, electronic signature compliance, and validated backup procedures were implemented to ensure adherence to regulatory standards.
Checkpoint 2: Information Technology – The Infrastructure Foundation
While QA focused on compliance, IT addressed the technical backbone required for secure and reliable operation. Their responsibilities extended beyond connectivity to include system security, data protection, and lifecycle management.
Infrastructure Assessment
IT reviewed hardware and software requirements, including operating system compatibility, patch levels, and antivirus policies. Decisions regarding standalone versus networked configurations were documented and approved.
Network and Security Architecture
Secure integration into the corporate network was achieved through segmentation, firewall configuration, and encrypted communication protocols. User authentication was aligned with enterprise identity management systems.
System Hardening and Patch Management
Security patches were applied, unnecessary services disabled, and system configurations documented to ensure reproducibility and audit readiness.
Data Backup and Recovery
Robust backup procedures were implemented, including validation of restore capabilities, safeguarding critical data against system failures.
Access Control and Governance
Role-based access management was enforced, supported by password policies compliant with regulatory requirements. Change control processes ensured configuration integrity throughout the system lifecycle.
By implementing these measures, IT provided a secure and compliant infrastructure, enabling the instrument to operate reliably within the regulated environment.
Bridging the Domains: The Role of Lab IT
As coordination progressed, the complexity of aligning laboratory operations, QA, and IT became evident. Each domain operated under distinct priorities and terminology:
- Laboratories focused on scientific performance and timelines and ensured their readiness for the go-live through user trainings and establishing SOPs.
- QA enforced regulatory compliance and documentation integrity.
- IT ensured system security and infrastructure reliability.
To achieve successful integration, a unifying function would be required—one capable of translating requirements across these domains and establishing a coherent implementation framework.
It appeared to Dr. D. that such a role could ideally reside within a Lab IT Support function, as this area is positioned to provide:
- Consolidated governance for instrument qualification and software validation.
- Harmonized user management and instrument system configuration under controlled procedures.
- Structured communication channels ensuring transparency and accountability.
Through this coordinated approach, the project evolved from fragmented efforts into a controlled, compliant, and efficient implementation—supporting both operational objectives and regulatory obligations.
Conclusion
Every laboratory will encounter similar challenges to the one Dr. D. works in: legacy instruments, time pressure, and the intricate interplay between IT, QA, and laboratory operations - all while coordinating across multiple teams who are already stretched with their day-to-day responsibilities. This also adds an organizational change management (OCM) dimension to the mix.
With the right structure and expertise, these challenges can be transformed into opportunities—paving the way for greater efficiency, compliance, and digital maturity.
At wega Informatik, we understand that integrating instruments into a regulated environment is never just about technology. It’s about compliance, connectivity, and performance—working together seamlessly.
Our Lab IT Support combines proven methodologies with deep industry expertise to deliver validated instrument systems, secure data workflows, and efficient processes. The result? Your laboratory can focus on what truly matters: advancing science and innovation.