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MODULE #04Production Ready (Active)Equipment & Infrastructure

Infrastructure

Register of production equipment, with its inspections, servicing and repairs – in one place.

The Infrastructure module manages the register of production equipment, its inspections and servicing. For each device it keeps the history of maintenance actions (inspections, servicing, repairs) together with documentation and stores validation documents. Devices are linked to the products they are used to manufacture.

Primary Users
People responsible for equipment, QMS team, selected people and departments
Register:Production equipment
Actions:Inspections, servicing, repairs
Validation:Documents kept with the device
Compliance Standards:ISO 13485:2016 point 6.3
Business & Regulatory Value

Why Your Team Needs This Module

The main benefits this module brings to your team’s day-to-day work.

Register of production equipment

All equipment in one table: ID, location, last service and inspection, assigned products and a colour-coded status. Columns are chosen by the administrator.

Inspections and servicing on a schedule

For each device you set whether it is subject to inspections and servicing, how often and when the first one takes place. The date of the next inspection is visible.

Complete history of actions

Inspections, servicing and repairs in one log (date, action, person responsible) – each action with its own documentation.

Equipment linked to products

You assign to a device the products it is used to manufacture. The instruction for use and validation documents are attached to its record.

Functional Scope

Key Features of the Module

What exactly this module can do.

Device record

Name, ID number, location chosen from a list, assigned products (there can be several) and the instruction for use as an optional attachment.

Locations from a single list

Locations are defined at the start and chosen from a list, so “room 1” and “first room” never mean two different places.

Log of inspections, servicing and repairs

Date, action, person responsible or service technician. The device name and ID are filled in automatically, and documentation can be attached to each action.

Device validation

Validation documents are uploaded as attachments, when adding the device or later.

Access for selected people

The module does not have to be visible to all employees. Devices are added, edited and viewed by selected people or departments with granted permissions.

Cloud Security & EU Compliance
AWS architecture & GDPR
AWS EU
Data Location (EU Only)
Servers located only within the European Union (AWS Frankfurt / Warsaw), 100% GDPR, no data transfer outside the EEA.
Immutable Audit Trail
Every change, approval and entry is logged with a tamper-proof timestamp and the user’s identity (an ISO 13485 requirement).
Security & Encryption
Data encrypted in transit (TLS 1.3) and at rest (AES-256) for all files and the database.
Role & Permission Control (RBAC)
Separated permissions for the roles: PRRC, QMS Representative, Department Head, Employee and Auditor.
Discuss your requirements with an expert
Seamless Data Flow

How this Module Connects with Other QMS Processes

NexiMed modules work together. Below are the processes related to this module.

Related process

Product Realization

Equipment from the register is linked to the production of the products it is used for

Coming soon
Questions & Answers

Module Implementation FAQ

Who sees the module and can add equipment?

The module does not have to be visible to all employees – selected people or departments have access. Equipment can be added and edited by people who have been granted permission: during implementation we agree with the client who receives it, or we let the company administrator grant it.

What is recorded for an inspection, servicing and a repair?

The device name and ID are filled in automatically. Inspection: date, description of actions, person performing it and optional attachments. Servicing: date, description of actions, service technician and attachments. Repair: date, description of the problem, description of actions, person responsible or service technician and attachments.

Where does the inspection frequency come from?

You choose the frequency when adding the device, together with the date of the first inspection, but it should follow the company’s procedures. During implementation we remind you to describe in them where it comes from and how it is planned.

Online Demo

See Infrastructure in Action

Schedule an online demo with NexiMed specialists and see how this module can support the processes in your company.

Have questions?
Let's talk about your processes.

Not sure which package to choose? Or maybe you need a custom integration? Our engineers will be happy to help.