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MODULE #05Production Ready (Active)Suppliers & Materials

Purchasing

Register of qualified suppliers, their evaluations, and materials and batches – in one place.

The Purchasing module has two tabs: Qualified suppliers and Materials and services. For each supplier it keeps details, documents, initial and periodic evaluations and the link to audits, and for materials – batches from ordering through to release. The company sets its own procedures for suppliers and material traceability, and the module helps keep records in line with them.

Primary Users
Purchasing team, quality team, people responsible for suppliers and receipt of materials
Register:Qualified suppliers
Evaluations:Initial and periodic
Batches:Receipt and release
Compliance Standards:ISO 13485:2016 point 7.4
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 qualified suppliers

Suppliers in one table: number, type, scope of supply, risk category (critical, important, standard), status, and the next evaluation and next audit. Filtering by every column.

Initial and periodic evaluations

Forms with criteria and weights, 1–5 scoring and a weighted result in percent. A supplier’s first evaluation is the initial one, every following one is periodic.

Materials, batches and release

Every batch has a status (ordered, awaiting release, released, rejected, expired) and a history of changes. A batch is released by a person with the appropriate permissions.

NexiMed AI

CoA read by NexiMed AI

Upload the CoA or delivery document, and NexiMed AI reads the LOT, expiry date, quantity and test results, fills in the batch receipt form and compares the results with the material specification, pointing out deviations. The decision to release the batch is made by a person with the appropriate permissions.

Integrated with NexiMed AI
Functional Scope

Key Features of the Module

What exactly this module can do.

Supplier record

Company and contact details, risk category, status and tabs: materials and services, evaluations, audits, documents and notes. A new supplier enters the register with the status “Qualification in progress”.

Two evaluation forms

Initial (one-time) and periodic evaluation. Sections: general, material, service, documents and audit – displayed depending on the supplier type.

Documents with an expiry date

You upload contracts and certificates to the supplier record. If you give an expiry date, the document status (valid / expired) updates automatically.

Material and service records

A material has batches, a service has performances. To both you assign a supplier from the list of active suppliers of the right type, and the related products.

Receipt and release of batches

Ordering a batch, receiving the delivery (LOT, expiry date, quantity, CoA) and releasing or rejecting it with a justification. The steps required for release are set by the manufacturer during configuration.

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

Audits

From the supplier record you go to its audits in the supplier audits tab

Coming soon
Related process

Product Realization

From the material used to its supplier and back; control and release of a material batch

Coming soon
Related process

NexiMed AI

Reads the CoA on batch receipt and checks the results against the material specification

Learn more
Questions & Answers

Module Implementation FAQ

How often are suppliers evaluated and who decides?

The frequency of evaluations and audits is defined when the application is configured for the client and should follow their procedure. Example: critical suppliers are audited and evaluated every year, important ones are evaluated every year without an audit, standard ones are evaluated once every 2 years without an audit. Audits do not apply to every supplier: when adding a supplier you indicate whether they are required.

How does the initial evaluation differ from the periodic one?

The initial evaluation is always a supplier’s first evaluation and can be carried out only once. Its outcome is the decision “Qualified / Not qualified”. Every following evaluation is periodic, with the result “Positive / Negative”, and takes into account, among other things, deliveries, nonconformities and the previous result.

Who releases a batch of material and what comes before release?

A batch is released only by a person with the appropriate permissions. Which steps are required is set by the manufacturer during configuration: it can be a quality control of the raw material (recorded in the production module) or release based only on the documents received with the delivery.

Online Demo

See Purchasing 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.

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