When the standard demands evidence that Excel cannot deliver
Every management system creates obligations to keep records: among other things monitoring measuring equipment, evidencing training, tracking actions, evaluating suppliers, documenting nonconformities. In most companies that ends up in spreadsheets. It works, until there are too many of them, until nobody knows any more which version applies, or until an audit finds no evidence that an action was actually effective.
We build the solution that takes this over. And because we audit the same standards, we know in advance what it has to be able to do.
Why these two belong together
Consultancies tell you which evidence the standard requires. Software houses build you a system but do not know the standard. The effort that arises in between is carried by your officer in the end, as a translator between the two worlds.
With us, that step disappears. Whoever carries out your internal audit can also develop the database behind it.
Who this is for
- Your record keeping consists of spreadsheets that have grown over the years and that nobody has a full view of any more
- You have two systems holding the same data, and you maintain them twice
- The last audit raised a point about incomplete records, or records that could not be traced
- You use software in a regulated environment and need evidence that it is fit for its intended purpose
- Your standard software can do almost everything, just not the one report your customer wants to see every quarter
What we build
Custom databases
Applications for exactly the task in front of you – measuring equipment management, action tracking, supplier evaluation, training records, document control. Tailored to your process rather than the other way round.
Interfaces
Two systems that do not talk to each other are the most common cause of duplicated data entry. We connect them – ERP, laboratory system, time recording, customer portal, interfaces to the authorities.
Software validation
Where the standard requires it, in the context of ISO 13485 or ISO/IEC 17025 for instance, we provide the documented evidence that a piece of software is fit for its intended purpose and works reliably (computerised system validation).
Reporting and automation
Recurring evaluations, reports and data transfers that are currently put together by hand.
What we work with
The technology follows the task, not the fashion. In practice that usually means:
- Databases as the core of the solution, with separate permissions and a history that shows who changed what and when
- Applications in the browser – nothing to install, reachable from the second site and from home as well
- Interfaces to ERP, laboratory systems, time recording or customer portals, as a file, as a web service or directly on the database
- Automation of recurring routines – including portals that offer no interface at all and would otherwise have to be operated by hand
- Reports that produce the sheet your customer or your auditor wants to see at the push of a button
What we deliberately do not do is sell you a platform of our own that your data is then locked into. The data sits in your database, on your server, in your cloud, in a format that can also be managed in-house.
What you get
- A solution that reflects your process, not a process dictated to you by a standard product
- Documentation that can be presented in a certification audit
- For applications subject to validation: the complete validation evidence
- Someone who understands both sides – the requirement of the standard and the code
How we work
Understand what is really needed
The solution people ask for is often not the one they need. We look at the process before we talk about technology.
Smallest sensible scope first
An application that solves one task well is worth more than one that half-does everything. It grows once it has proved itself.
Build it and try it in daily use
With the people who will be working with it – not just with management.
Document it and, where necessary, validate it
In a way that holds up in an audit.
Support it
New editions of standards, new requirements, new sites. Software ages just like a management system.
Who handles this at our end
Rüdiger Rammé – IRCA certified and registered QMS / OHSMS Lead Auditor #01192806. Development of databases, interfaces and automation solutions, software validation in regulated environments.
Telephone: +49 4131 2198634
Related topics
Frequently asked questions
What does a custom database solution cost?
Considerably less than most people expect, because we start with the smallest sensible scope. A self-contained application such as measuring equipment management is in a different order of magnitude from a company-wide solution with several interfaces. After a conversation about the process we can narrow it down.
Why not simply buy standard software?
Often that is exactly the right answer, and then we say so. Custom development pays off when your process differs from what the market treats as normal, when you only need a small part of a product, or when the standard solution would force you to rebuild a process that works.
What does software validation actually mean?
It is the documented evidence that a piece of software is fit for its intended purpose and reliably does what it is supposed to do. Several standards require this for software that controls quality-relevant processes or holds records – including home-made spreadsheet solutions and self-written macros, which is regularly overlooked.
Do our Excel files have to be validated?
If they hold quality-relevant records or perform calculations for test results: yes, frequently. It is one of the most common audit findings and a good reason to check whether an application of your own is not the simpler route anyway.
Do you also take over existing applications?
Yes. Often the point is to make a solution that has grown over the years replaceable, or to fill in missing evidence.
Do you work with our IT department?
Yes, that is the normal case. We supply the specialist application, your IT runs the infrastructure.
Let us talk about it
The first conversation is free and without obligation. It usually takes half an hour. Afterwards you know what to expect and whether we are the right people for your project.
- Rüdiger Rammé, Lüneburg – phone: +49 4131 2198634
- Marion Rammé, Hamburg
- Email: all@bout-quality.de
Prefer to write? The contact form reaches us just as well.