For pharmaceutical companies
No deadline missed.Every certificate on time.
The platform obtains new versions of your supplier documents itself, your quality assurance reviews and approves.
- Requests and reminders by email
- Retrieval from portals, EudraGMDP and EDQM
- Signed approval, entry in the ERP
- ~80 %
- obtained automatically
- 25+
- years of experience
- 1 click
- to the audit package
Sound familiar?
The supplier file goes out of date every day.
GMP certificates, CEPs, quality agreements, ISO certificates, statements and questionnaires: per supplier and manufacturing site, a dozen documents add up quickly. Each has its own deadline, and each has to be right at the next inspection.
“The deadlines live in Excel and Outlook reminders.”
Every deadline is tracked, including documents without an expiry date, by the interval in your SOP.
“Every document means emails back and forth.”
Request, reminder and escalation to purchasing run by themselves.
“An expired certificate is only noticed in the audit.”
Before anything expires, the new version has been requested, and you see open items at once.
“Distributor or manufacturing site? The address does not match.”
Every document is checked against master data and registers, including site and address.
The platform
From deadline to audit package.
Four steps your team handles today. The platform takes over the routine, your quality assurance keeps the decision.
Monitor
Every deadline in view.
The overview shows which documents are current, which expire soon and what is ready for review. Documents without an expiry date, such as statements or questionnaires, get a review interval from your SOP.
- Status per supplier, material and manufacturing site
- Advance warning and follow-up by your rules
Request
New versions arrive by themselves.
When a document expires, the platform requests the new version from the supplier's quality contact, referring exactly to site and material. If nobody answers, it sends reminders and escalates to purchasing.
- Retrieval from public registers such as EudraGMDP and EDQM
- Download from supplier portals where they exist
Review and approve
Read, matched, presented.
Every incoming document is read and checked against your master data: issuer, holder, manufacturing site, scope and validity. Your quality assurance sees at a glance what matches and approves with an electronic signature.
- Original stored unchanged, with checksum and source
- Entry in your ERP system, such as SAP QM
Audit-ready
The audit package at the push of a button.
When an inspection or customer audit is announced, the platform compiles everything asked for in supplier qualification. Open items appear in the package with their action, instead of surfacing in the audit.
- Approved supplier list, valid documents and approval records
- Audit trail extract for the chosen cut-off date
Control
The platform works. Your QA decides.
Supplier documents follow strict rules. So the platform approves nothing on its own and records every step traceably.
Who approves?
Always a person in your quality assurance, with an electronic signature. With the four-eyes principle if your SOP requires it.
What happens with exceptions?
If an answer is missing or a document does not fit, your team takes over. The platform shows what is open and why.
Can we trace later what happened?
Every step is in the audit trail: who or what, when and from which source.
How we start
From the first conversation to audits on autopilot.
We start with your real suppliers and documents, not with examples. Each step ends with a result, and you decide whether we continue.
30 minutes
First conversation
We show you the platform, and you tell us how your supplier qualification works today and where it gets stuck.
ResultAn honest assessment of whether it pays off for you
With your data
Pilot with your suppliers
We start with one supplier group, such as excipient suppliers, and the rules from your SOP. Beforehand we agree how we measure success.
ResultA measurable comparison with your current effort
After the pilot
Integration
We connect the platform to your ERP system, your mailbox for supplier correspondence and your suppliers' portals.
ResultDocuments and status where your team works
Ongoing
Operation and support
If you like, we run the platform for you and adjust rules when your SOP or your suppliers change.
ResultA supplier file that stays current
Frequently asked questions
What companies ask us.
Which documents does the platform manage?
All master documents of supplier qualification, for example GMP certificates, manufacturing authorizations, CEPs, quality agreements, ISO certificates, statements, questionnaires and audit reports. Which documents each supplier group needs and which deadlines apply, we set up according to your SOP.
What if a supplier has no portal?
Then the platform requests the document by email from the quality contact, sends reminders and escalates to purchasing by your rules. For most mid-sized suppliers that is the usual route.
How do you handle Annex 11?
The platform is itself a computerized system, and we treat it as GxP-relevant. Audit trail, roles, electronic signature and unchanged originals are part of the platform from the start. We plan validation and supplier assessment together with you, following your requirements.
What happens to our data?
It stays on your own server, in your cloud account or on your premises. Which data the software may see and which AI model is used, we decide together with you.
Does it work with our ERP system?
We connect the platform to the system where your supplier approvals are kept today, such as SAP QM. In the first conversation we clarify which interfaces you have.
What does it cost?
It depends on the number of your suppliers and the scope of the integration. After the first conversation you receive a concrete proposal for the pilot.
Request a demo
How current is your supplier file?
A few short details are enough. In the demo we show you the platform with examples from your daily work and assess honestly whether it pays off for your company.
Nataly, David and Markus read your request personally. One of us will get back to you.