One platform,
shared rules
Each NexiMed module runs a different process, but all of them work by the same rules: with a change history, approval stages, deadlines and evidence in one place. We set the platform up in line with your company’s procedures, and the modules hand cases over to each other, so a process doesn’t break off between departments.
Learn one module – find your way in all of them
The same mechanisms recur in every process. Your team gets going faster in each new module, and an auditor finds evidence the same way everywhere.
History that doesn’t disappear
Every stage and every change is recorded – including what didn’t work. Months later you can see who made a decision, when and why.
- CAPA: a negative effectiveness review stays in the history
- Purchasing: the status history of every batch
- Infrastructure: a log of inspections, servicing and repairs
The next step after the previous one is approved
The process guides you step by step. The next stage opens once the previous one is ready, so no required step gets skipped.
- CAPA: the action plan only after an approved root cause analysis
- Training: the supervisor’s review after the participant’s
- Purchasing: a supplier’s first evaluation is always the initial one
Statuses and deadlines in plain sight
Every case has a status, a deadline and a responsible person. Instead of asking around what is overdue, you see it in the register.
- CAPA: an overdue deadline marked in red
- Infrastructure: the date of a device’s next inspection
- Purchasing: a supplier’s next evaluation and next audit
Evidence where it is created
Certificates, validation documents, CoAs and evidence of completed actions are attached directly to the case – not to a folder on a drive that nobody finds later.
- Training: participants’ certificates, also visible in their profiles
- Infrastructure: validation documents on the device record
- CAPA: evidence of implementation for every action
Modules that hand cases over to each other
A problem found in one place doesn’t end as a note. The case moves on to other modules and the links are recorded – from the source of the problem to the proof that the action worked.
Example: from a problem to an effective action
Source of the problem
The problem comes e.g. from a complaint, an audit or production. The CAPA records its source, so you always know where it came from.
Root cause analysis
The responsible person determines the cause and checks whether it affects other products or processes. NexiMed AI suggests possible causes.
Action
One of the actions can be a team training. The completed training becomes evidence that the action was carried out.
Effectiveness review
Only a positive review closes the CAPA. A negative one sends the case back to the action plan.
Other links across the platform
When a batch is received, NexiMed AI reads the CoA and compares the results with the material specification.
Devices are assigned to the products they are used to manufacture.
The supplier record links its evaluations with the audits carried out at that supplier.
Fitted to your procedures, not the other way round
Frequencies, deadlines and required steps follow your company’s procedures, not settings imposed by the system. We set them up during implementation, and some of them can later be changed by an administrator on your side.
- Frequency of supplier evaluations and audits – different for critical, significant and standard suppliersPurchasing
- Steps required to release a batch – quality control or release based on the delivery documentsPurchasing
- Deadlines for the training effectiveness review by the participant and their supervisorTraining
- Frequency of inspections and servicing for each deviceInfrastructure
- Columns shown in the registersTraining, Infrastructure
- Pick lists, e.g. locations – so that “room 1” and “first room” are never two different placesInfrastructure
During implementation we also point out what is worth describing in your procedures – e.g. what the inspection frequency is based on or when a training does not require an effectiveness review.
Everyone sees what they need
Access follows a person’s role in the company. During implementation we agree who gets which permissions, or we let an administrator on your side grant them.
Employee
Their own trainings and assigned tasks, e.g. a CAPA action they need to carry out and document.
Manager
Also their subordinates’ trainings and the review of whether they apply the knowledge in practice.
Quality team
The full picture, e.g. all trainings in the company, without collecting information from each department.
Authorised people
Key decisions, e.g. releasing a batch, are made only by people with the right permissions. Selected modules can be visible only to designated departments.
AI prepares, a person decides
NexiMed AI is a learning agent present across the whole platform: it knows the procedures you teach it, answers in the chat and helps inside modules. The same rule applies in each of them – AI prepares a proposal, and an authorised person makes the decision.
Questions and a knowledge test based on an uploaded procedure.
The person creating the training adds the test.
Data read from the CoA and the results compared with the material specification.
A person with the right permissions releases or rejects the batch.
Possible causes of the problem and 5 Whys-style guiding questions.
The responsible person picks, corrects or rejects the proposals.
See the platform on the example of your processes
Book an online demo. We’ll show you how the modules work together and how to set them up in line with your company’s procedures.
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.