A critical characteristic of connected instrumentation is the involvement of multiple technical layers that interface with the instrument and support the collection, transmission, analysis, and distribution of lab data. These layers may require different subject matter expert (or teams) to oversee their operation, maintenance, and compliance.
However, the connected instrumentation environment often faces the challenge of determining who owns an affected component, who is accountable, and who has the authority to make decisions when different teams are involved in a single process. A scientist or analyst might use an instrument to test samples, while IT and instrumentation may be maintaining the instrument and network.
Finally, without a defined governance framework, responsibilities can remain unclear, and gaps may become visible when a fault occurs. This can create ownership and decision-making blind spots, resulting in gaps in coordination and escalation.
For example, when an instrument requires a software patch, ownership may be unclear over who monitors patch availability, determines whether the patch should be applied, or coordinates the change with the instrument owner.
Mapping the ownership landscape
Connected instrumentation combines different technologies within a digital laboratory ecosystem.
- Instrument / Hardware – Physical equipment to perform analysis.
- Maintenance / Service – For example, corrective, predictive, and condition-based maintenance
- Software - Software solutions used to control the instrument, and perform data workflows
- Network - The infrastructure that enables communication between instruments, workstations and computing devices.
- Orchestration Interface - The integration of coordination between instruments, software systems, data sources, and laboratory workflows.
Connected instrument ecosystem map
One way to identify ownership gaps is to create a connected instrument ecosystem map. This map can identify the instrument and supporting components such as software, data systems, services, and organizational functions. Lab managers can use this ecosystem map to identify potential ambiguities in ownership or decision-making authority.
An example map for an HPLC connected to a chromatography data system (CDS) and lab network could take the following form
Connected Instrument Component | Ownership Question |
HPLC hardware | Who is responsible for maintenance? |
(HPLC)Computer System | Who is responsible for the satisfactory working of computer? |
CDS software | Who is responsible for CDS software management? |
Network | Who is responsible for managing the connectivity? |
User Access | Who is responsible for authorizing and managing access? |
Data Storage ( and Backup) | Who is responsible for data protection and recovery? |
Vendor Support | Who is responsible for vendor support and escalation? |
Rather than giving fixed ownership assignments, the map directs lab managers to identify who should own each component according to their governance structure, SOPs, and organizational structure. For example, responsibility for HPLC hardware may reside with the lab or engineering department. For warranty-covered repairs, certain technical responsibilities may be assigned to the vendor for a defined time period, while the laboratory (or engineering) retains overall ownership.
Answering these ownership questions helps identify the appropriate owner for each component and highlight areas of unclear ownership.
Assigning accountability
Assigning accountability for each component is the next step after the connected instrument map has been created.
In a traditional laboratory environment, operational responsibilities may be clearly separated among functions. However, connected instruments can introduce different dependencies across engineering, IT, lab personnel, and external vendors, with varying levels of complexity. Involvement from different departments does not necessarily mean that accountability should be shared among them, nor does a single group need to be accountable for every component.
RACI matrix
A RACI matrix can be used to assign accountability and responsibility. RACI stands for Responsible, Accountable, Consulted, and Informed.
The following RACI matrix is only indicative and actual assignments may differ depending on the organization structure, system ownership, and approved SOPs. Additionally, each activity should have one clearly identified accountable party, with responsibility defined according to the organization structure and approved procedures.
| Lab manager | Instrument user (scientist or analyst) | IT Dept | Vendor | |
| Patch management | C | I | A/R | C |
| Data backup and recovery | I | C | A/R | C |
| Return to service approval(after major upgrade) | A | C | C | C |
Example RACI matrix for a connected laboratory activity
Defining decision rights
Connected instrument labs involve multiple groups, and lab managers should clearly designate the authority to make or approve each critical decision.
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Decision authority can depend upon many factors, including lab governance, organizational structure, operational scope, approved SOPs, technical expertise, ownership, and business requirements.
For example, for a given instrument, a technical decision may require authorization from engineering or IT. Whereas, for the same instrument, compliance-related decisions may require authorization from designated lab or quality personnel.
Decision rights checklist
A trigger or escalation checklist can help lab managers identify when ownership, accountability, or decision authority should be reviewed and what action should follow.
Decision | Decision Authority |
Software update | System owner |
Network configuration change | IT manager or authorized person |
Vendor remote access | Lab manager |
Instrument taken offline | Lab / engineering authority |
Data restoration | IT manager |
Return to service | Designated laboratory authority |
Please note that the above is only an illustrative checklist. Actual decision authority should be assigned according to individual organizational structure, SOPs, and operational requirements.
When classifying decision makers, distinction should be made between the executor and the authorizer. For example, an IT technician may perform a system upgrade; he or she may not necessarily have the authority to approve or authorize the change. Similarly, a system owner may report a fault in an instrument, while the decision to take the instrument fully offline may require authorization from the designated laboratory or technical authority.
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Establishing escalation and lifecycle review points
Responsibility and accountability for a connected instrument do not necessarily remain fixed throughout its lifecycle. Changes to the instrument, its supporting system, or organizational structure can introduce new dependencies or risks that require responsibilities and decision authority to be reassessed.
Examples of events or escalation triggers that could trigger escalation or review of responsibility include instrument failure, software upgrades, change in network infrastructure, or relocation of instrument.
Additionally, lab managers should periodically renew the ownership model at defined life cycle review points, for example, before go-live or when organizational responsibilities change.
Trigger or escalation points checklist
A practical tool would be a table that identifies key trigger or escalation points, with corresponding actions.
Trigger Points | Actions |
Technical changes | Review instrument dependencies, ownership and decision authority.
Example - cloud migration may require re-assessment of responsibilities for system access, data management or vendor support. |
Organizational change | Review existing accountability and decision rights. Re - assign them where responsibilities have moved. Example - departmental merger may create gaps or overlaps in ownership, that needs to be addressed |
Compliance and risk events | Escalate the event to designated authorities and review whether existing responsibilities need revision. Example - audit finding could reveal unclear ownership of access controls or corrective actions |
Clarifying ownership before the next failure
A connected instrument environment can involve multiple operational groups, vendors, and systems, but this complexity does not mean that ownership or accountability should remain unclear. By mapping ownership, assigning accountability, decision rights, and defining escalation and review points, lab managers can clarify responsibilities when failures occur. The goal is not to prevent failure but to ensure that when instrument breakdown occurs, everyone knows who owns the problem, who has the authority to approve the next step, and in what cases the issue should be escalated.
