Release within 2 working days of the last test result. Without replacing your validated systems.
¹ IntuitionLabs, Pharma KPI Benchmarks 2026
The batch is produced, the test results are in. Then it waits to be compiled, reviewed and signed. Use your own figures to see how much capital this wait ties up and how much QA time it costs.
Releases × waiting days ÷ 365 = batches in quarantine at the same time on average; × manufacturing cost = tied-up capital (inventory is carried at manufacturing cost). Target 2 days, cost of capital 8% p.a. on the capital freed. QA effort: assumes 50% less review time through Review by Exception, €75/h fully loaded. A documented MES case shows 70% (Körber, Sharp Packaging).
Remediation after an FDA warning letter costs around USD 750,000 on average, in some cases tens of millions. Data integrity is a recurring focus of the findings, and data transferred by hand between systems is a typical weak point.
Source: Water Online (avg. remediation); FDAnews, West-Ward/Hikma
Paper-based releases typically take 10 to 40 days, a single review 48 hours on average. In the example below, 2 of 66 entries carry an exception. All of them are read anyway.
Source: BioPharm International
The draft revision of July 2025 tightens the requirements for audit trails, their regular review and data exchange between systems. Exactly where e-mail and Excel bridge the gaps today. The final version is about to be published.
Source: European Commission / PIC/S, consultation draft July 2025Your systems are validated and running. The problem sits between them: the QP collects printouts from six systems, a lab technician retypes certificate values, and someone sets the status in SAP the next day.
Printouts from six systems.The QP reads every entry.
Your systems stay as they were validated. We fetch specification, result and batch status through existing interfaces and write back only the release status. The interface goes through your change control and is validated as a system in its own right.
Your systems stay as they were validated. We fetch specification, result and batch status through existing interfaces and write back only the release status. The interface goes through your change control and is validated as a system in its own right.
Everything within specification is documented, not read. The QP sees the two entries that need a decision, with origin, lab result and open deviation. This requires an electronic batch record. With paper records, we start with CoA checks and deviations.
E-signature under EU GMP Annex 11 and 21 CFR Part 11. The status in SAP and the release certificate follow automatically, with a complete audit trail: who, when, what, why.
Five steps, example data. Swipe through.Click your way through.
Today: A lab technician types the values from the PDF and compares them with the specification in the binder. Around 20 minutes per delivery.
You can click into it yourself at any time.
| Test | Status | |
|---|---|---|
| Identity (IR)conforms | conforms | open |
| Assay (HPLC)98.5 to 101.0% | 98.5 to 101.0% | open |
| Water (KF)≤ 0.50% | ≤ 0.50% | open |
| Impurities≤ 0.20% | ≤ 0.20% | open |
| Heavy metals≤ 10 ppm | ≤ 10 ppm | open |
| Particle size D90≤ 90 µm | ≤ 90 µm | open |
Water content 0.53% above the 0.50% limit. The material stays blocked, the deviation is being raised.
Software that doesn’t survive your validation is not a relief, it’s a finding. That is why the validation package is part of the fixed price, not a service sold afterwards.
Six questions on batches, systems and release time. Afterwards you know which building block brings the most and what it costs. No presentation, no pitch.
Fixed scope, fixed price, requirements signed off together. Your IT and QA are involved from the first week.
The final payment is due when the building block runs in your plant and the validation documents are in place. Not before.
Read certificates, check them against the approved specification from SAP, raise a deviation directly. The fastest way in: one process, one goods receipt.
All release-relevant data per batch in one view, Review by Exception, Part 11 signature, status back to SAP.
From the report to the effectiveness check, with deadlines and responsibilities. Every open deviation is visible in the cockpit before it holds up the release.
A new SOP version is approved: the system uses the training matrix to determine who is affected, creates the training requirement and tracks the record through to confirmation. In an inspection, every record for the current version is available at once.
All release-relevant data per batch in one view, Review by Exception, Part 11 signature, status back to SAP.
Further stages on the same data: Change Control, Product Quality Review.
Check for my plantWe replace nothing. We read through existing interfaces and write back only the release status. This interface is a change to your system landscape and goes through your change control. We supply the validation to GAMP 5; the validation of your existing systems remains untouched.
No. Your training stays with you. We make sure every new SOP version triggers the training requirement for all affected roles, deadlines are tracked, and every record is linked to the right version.
We do not use generative AI for release-relevant decisions. Extracted values are shown next to the original and confirmed by a person; every confirmation is in the audit trail. The draft of the new Annex 22 allows only static, deterministic models in critical GMP applications. Our solution is built to that.
URS, risk assessment, IQ/OQ/PQ templates and supplier qualification are included in the fixed price. We run IQ and OQ together with you. PQ and approval stay with your QA, as they must.
Yes. The basis is EU GMP with Annex 11, which applies to every manufacturer with a manufacturing authorisation. We also cover 21 CFR Part 11 in case you supply the US.
[ZEITRAUM] for the first building block, depending on your interfaces. We give you the realistic figure for your plant after the quick check, not before.
ERP experience from industry, software for Google and the German federal government, expertise in cybersecurity.
We only call back if your plant fits what we build. Otherwise we tell you where you would be better served.