.png?width=128&height=75&name=Koerber_Logo_RGB_Black_without_protective_area%20(4).png){kind=logo}
Pharma Validation
Computerized Systems Validation Services for Pharma and Biotech
Ensure full compliance with ISO 9001, FDA 21 CFR Part 210/211, FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 – with risk-based computerized systems validation services tailored to your systems and processes.
-
Compliant validation packages.
-
Risk management with a risk-based validation approach
-
Rapid on-site response in urgent situations
« Our consulting services also extend beyond the validation services to cover strategic and organizational aspects of your areas of business. »
Stefan Münch, Business Director Validation & QM
How it works
Step 1: Briefing & Risk Analysis
You describe your system challenges, we identify the GxP-critical areas.
Step 2: Tailored Concept
We design a customized validation plan based on the lifecycle model and the V-model (GAMP 5).
Step 3: Execution and Reporting
We implement with full documentation – ready for daily use and for audits.
Why We’re Different
- Risk-based validation. We focus on GxP-critical systems to reduce unnecessary work.
- Compliance expertise. Aligned with ISO 9001, FDA 21 CFR Part 210/211, FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5
- System versatility. Validation for all MES, LIMS, laboratory systems, and on premises or cloud platforms.
- Audit-ready results. Documentation and processes built to withstand any inspection.
Who We Work With
-
Pharmaceutical, Biotech, and MedTech companies
-
Systems: MES, LIMS, ERP, Manufacturing Equipment, Laboratory Systems
-
Early-stage startups to top-tier global companies
Frequently Asked Questions
Why do I need to fill out the information requested?
We will always keep your personal information safe.
We ask for your information in exchange for a valuable resource in order to
(a) improve your browsing experience by personalizing the Koerber site to your needs;
(b) send information to you that we think may be of interest to you by email or other means;
(c) send you marketing communications that we think may be of value to you. You can read more about our privacy policy here.
Is this really free?
Absolutely!
Just sharing some free knowledge that we hope you’ll find useful. Keep us in mind next time you have pharma manufacturing questions!
Who is this for?
This content offer is for anybody in pharma and biotech who is looking for support in their daily operations.