GMP manufacturing, with software you can validate.
Do you make medicines, veterinary medicines, supplements or pharmaceutical packaging under GMP? Then the question is not whether your software is certified, but whether you can validate it. Frontlink provides the functions and the evidence you need for that.
Who certifies what.
- The GMP certificate is yours
The inspectorate certifies your company and your processes, not the supplier of your software.
- Software is validated, not certified
EU GMP Annex 11 and 21 CFR Part 11 ask you to show that your system does what it should. You do that risk-based, following GAMP 5 and Computer Software Assurance.
- Our role: supplying the evidence
We show how we develop, test and change the software, and supply the documents that support your validation.
What Frontlink records.
The functions an auditor asks about, built into the platform.
| What | Time |
|---|---|
| Line clearance performedM. Jansen, operator | 07:02 |
| Fill weight corrected, 498 g to 502 gM. Jansen, reason: weighing error | 09:15 |
| Deviation reviewedS. de Boer, quality | 10:40 |
| Batch releasedS. de Boer, signed: release | 16:22 |
- Audit trail on every record
Who changed what and when, with the old and new value and the reason. The history cannot be edited.
- Electronic signatures
With name, time and meaning, such as performed, checked or released, and a reason where one is required.
- Access by role
Operators, quality and planners only do what their role allows. Personal accounts, no shared logins.
- Data integrity by ALCOA+
Data is recorded at the moment itself, by the right person, and stays complete and readable.
- Versioned instructions and recipes
A new version is only used after approval. Every batch shows which version it was made with.
- Hosted in the EU
The platform and your data run in a data centre in Germany, with a daily backup.
Validation, done together.
You stay in charge of your validation. We supply the building blocks and draw them up with you.
- User requirements (URS)
A template we fill in together for your processes.
- Risk assessment
Which functions are GMP-critical and how much testing they need.
- IQ and OQ test scripts with evidence
Executed tests with results and screenshots, ready for your file.
- Traceability matrix
From every requirement to the test that proves it.
- Change control and release notes
Every update described, tested and announced in advance, so you can judge what it means for your validation.
- Open to a supplier audit
Your quality team can assess us: how we develop, test, change and secure data.
Step by step, at your pace.
- Start outside the GMP-critical scope
Quotes, a customer portal for certificates of analysis and order status, or insight into machine stops and OEE. These usually do not touch batch release and save time straight away.
- Draw up a validation plan together
We decide which processes are GMP-relevant, which risks apply and which evidence is needed.
- Extend to GMP processes
Electronic batch records and line clearance, validated before they go into production.
- Keep it validated
Updates go through change control. You decide when a new version goes live for you.
Frequently asked questions.
Is Frontlink GMP certified?
No, and it cannot be: GMP certification applies to manufacturers, not to software. Frontlink is validated for your use. We provide the functions and documentation you need for that.
Does Frontlink comply with Annex 11 and Part 11?
Frontlink has the functions these rules ask for, such as an audit trail, electronic signatures and access by role. Whether your use complies, you show with your validation. We supply the evidence.
Who carries out the validation?
You stay responsible and approve. We draw up the documents with you and run the tests where you want us to, so your quality team mainly reviews.
Can we audit Frontlink?
Yes. A supplier audit, on site or remote, is welcome. We show how we develop, test, change and secure data.
Do we have to start with batch records?
No. Many companies start with quotes, the customer portal or machine stops. These usually fall outside the GMP-critical scope. GMP processes follow when you are ready.
Talk it through with your quality team.
Book a 30-minute call. We go through which processes are GMP-critical and what evidence you need from us.
Book a call