Ask anyone who has rolled out a manufacturing execution system in a GMP plant where the time went. Very few will say "configuring the software." Most will point to validation: writing specifications, drafting test scripts, executing IQ and OQ, closing deviations, and then doing a good part of it again when the first upgrade arrives.
Validation is not optional, and it shouldn't be. It is how you show a regulator, and yourself, that the system does what you need it to do. But a large share of the validation effort in a typical MES project goes into proving things the vendor already knows: that the audit trail records every change, that electronic signatures are linked to their records, that a user without the right role can't approve a batch.
That work should not start from zero at every site. With Vimachem, it doesn't.
What "pre-validated" means, and what it doesn't
Let's be precise, because your QA team will be.
No regulator recognizes "validated software" as something you can buy. 21 CFR Part 11 and EU GMP Annex 11 require you to validate your computerized systems for their intended use: your processes, your products, your environment. Only you can define that intended use, so only you can confirm the system meets it. GAMP 5 describes how.
GAMP 5 also lets you rely on your supplier's work where it is properly documented. Proving that the audit trail records every change, or that an electronic signature is linked to its record, does not depend on your intended use. It is the same at every site. That is what we mean by pre-validated: the product arrives specified, tested and documented to GAMP 5, so your validation effort goes to your intended use. That includes your requirements, your configuration, your performance qualification and your procedures.
That is also what the title means. You validate the system for your use. You shouldn't have to re-prove the product underneath it.
What you get before your project starts
Electronic Batch Records, Weigh & Dispense and Electronic Logbooks & Forms each come with a GAMP 5-aligned validation package:
- A standard User Requirements Specification (URS) to adapt into your own.
- Design and Functional Specifications.
- Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
- Traceability matrix linking requirements to tests and results.
- Release notes documenting every change.
Efficiency modules such as MA&OEE and Changeover Instructions often run without formal validation, but they can be validated on the same basis when you choose to.
Behind that package is a documented development lifecycle. Requirements, test cases, code reviews and defects are tracked in one system. New features are built with test-driven development and pass integration testing before a release candidate exists. Your supplier assessment or audit can review this lifecycle directly. That is the step that lets you rely on our testing, as GAMP 5 allows, instead of repeating it.
The technical controls that Part 11 and Annex 11 call for are part of the core product, not something configured on top of it: audit trails, role-based access and electronic signatures, with the data integrity controls that support ALCOA+. All three GMP modules use them throughout. The procedural side, your SOPs, training and periodic audit trail reviews, stays with you, as it would with any system.
The same applies at the equipment level. Our standard interfaces with packaging and serialization equipment from Wipotec, Uhlmann, Antares Vision, Seavision and Optel are pre-validated in the sense above: built, tested and documented by us. Connecting a line means qualifying your setup, not a new integration from scratch.
Configure, don't code
Here is where most of the time is won or lost.
Vimachem is purpose-built for pharma. Batch records, weighing and dispensing, logbooks and line performance come as ready-to-deploy, off-the-shelf modules, designed around how GMP plants work. It is a GAMP 5 Category 4 (Configurable) system. You set up your master batch records in the MBR Designer, your logbooks from drag-and-drop templates, and your OEE models and loss categories from configuration screens. The core of your system is configured, not coded. Where a process needs custom logic, such as a specific calculation, it stays small and contained. That part is treated as Category 5 and tested at code level, and only that part.
Under the risk-based approach in GAMP 5 Second Edition, your testing focuses on your configuration and your intended use. You verify that your batch record captures the right steps and limits, and you confirm that key controls such as the audit trail work in your configuration. You don't need to re-test the software's standard functionality in depth, because the supplier testing behind it is documented and available for your review.
Compare that with general-purpose platforms sold as a toolkit. They look flexible in a demo: build any app you want, exactly the way you want it, often starting from a template. The platform underneath may even come qualified. But if your MES is a toolkit, you are not buying a product. You are taking on a project. Every app you build or adapt has to be specified, tested and validated by your team, and maintained by your team for as long as you run it. When the people who built it leave, the validation file stays with you.
Flexibility is only useful if you can afford to keep it validated.
Questions to ask your MES vendor
Before you choose, ask these questions. The answers tell you whether you are buying a product or taking on a project:
- Who builds the first version of your batch record, and who owns it after that?
- Who executes validation on what gets built, and who revalidates each change?
- If the people who built your apps leave, who maintains them?
- When the vendor releases an update, who decides when you take it, and how much do you have to retest?
With a product, the vendor has already built, tested and documented the batch record functionality. You configure your recipes on top and validate that configuration, not the software underneath it.
Staying validated after go-live
Validation isn't finished at go-live. You have to keep the system in a validated state, and for many plants the real cost shows up at the first upgrade, when a vendor release forces a new round of testing on someone else's timeline.
We designed our release process around your change control, not ours:
- One major release per quarter and monthly minor releases, all optional. You decide if and when to upgrade.
- Release notes describe every change, so your risk-based assessment can set the revalidation scope instead of re-testing everything.
- Updated IQ and OQ documents come with every release.
- Upgrades go to your test environment first, for your own testing and approval, before anything touches production.
- Each customer runs on a dedicated environment, in our cloud or on your premises, so each site upgrades on its own schedule. No other customer's timeline decides yours.
What this means for your project
Put together, these add up to a shorter, more predictable project:
- Half the time of a traditional MES rollout, or less. A typical Vimachem EBR deployment takes 4 to 6 months. Traditional MES implementations of a similar scope often take a year or more.
- Your validation team works on process risk. Their time goes to what matters for your products and patients, not to re-proving standard product features.
- Each new module starts from the same documented base. Start with one module at one site, validate it, and add the next on the same foundation, with an impact assessment instead of a restart.
- A clear case for inspectors. Your validation file shows a documented supplier lifecycle, a supplier assessment, and traceability from each requirement to its test result.
An MES exists to help you release medicines faster. Validation shouldn't be the step that slows it down.
See the validation package
Want to see what your team would build on? Request a walkthrough of the Vimachem validation package with one of our CSV experts. The full package is available under NDA.
