FDA’s FY2025 data sends a clear warning: inspectors classified 78% of 1,309 drug quality assurance inspections as VAI or OAI, meaning most inspected sites showed conditions that required correction or regulatory attention. As digitalization in pharma industry accelerates, inspectors now assess more than whether an MES performs its basic functions. They examine audit trails, user access, electronic batch records, validation evidence, data review, and change control.
Therefore, companies evaluating koerber pharma software and PAS-X must understand both its manufacturing capabilities and its compliance limits. This guide explains how PAS-X supports GMP operations, where company controls still matter, and what inspectors expect from a validated pharmaceutical MES.
Table of Contents
What Is Koerber Pharma Software?
Koerber pharma software refers to Körber’s digital solutions for pharmaceutical, biotech, and cell and gene therapy manufacturing. At the center of this portfolio, Werum PAS-X MES controls, monitors, and documents production activities in real time. The pharmaceutical MES software guides operators through approved workflows while coordinating materials, equipment, process steps, and production data. In addition, PAS-X connects manufacturing operations with systems such as ERP and plant automation. Electronic batch records form a core part of the platform.
PAS-X converts approved master batch records into digital instructions, captures execution data, flags process exceptions, and gives quality teams a complete record for batch review and release
Why Pharmaceutical MES Software Matters for GMP Compliance
Pharmaceutical MES software strengthens GMP compliance by guiding operators through approved procedures, recording production data in real time, and reducing manual documentation errors. In addition, the system improves traceability through electronic batch records, audit trails, access controls, and exception management. However, an MES cannot guarantee compliance on its own. Companies must validate the system, define user roles, control master data, review audit trails, manage changes, and train employees.
Therefore, regulators assess both the technology and the governance around it. Strong computer system validation, data integrity controls, and lifecycle management help manufacturers meet expectations under 21 CFR Part 11 and EU GMP Annex 11.
Four PAS-X Controls That Inspectors Scrutinize First
Inspectors usually focus on four control areas that show whether PAS-X supports reliable batch execution, complete data traceability, secure system access, and validated lifecycle management:
The following four control areas show how effectively PAS-X supports compliant pharmaceutical manufacturing:
- Electronic Batch Records and Review by Exception (PDF)
- Audit Trails and Data Integrity (PDF)
- User Access and Electronic Signatures (PDF)
- Validation and Lifecycle Change Control (PDF)
Electronic Batch Records and Review by Exception (PDF)
PAS-X records each production step in an electronic batch record. Review by exception helps quality teams focus on deviations.
Download PAS-X Electronic Batch Records and Review-by-Exception Workflow Here
The infographic below shows how PAS-X controls batch execution from the approved master batch record through exception review and final batch release.
Audit Trails and Data Integrity (PDF)
PAS-X audit trails track critical data changes and user actions. Regular review supports data integrity and traceability.
Download FDA Guide to Audit Trails and Data Integrity in Pharmaceutical MES Here
User Access and Electronic Signatures (PDF)
PAS-X limits access through defined user roles. Electronic signatures link each approved action to a specific user.
Download FDA 21 CFR Part 11 Guide to User Access and Electronic Signatures Here
Validation and Lifecycle Change Control (PDF)
Companies must validate PAS-X for its intended use. They must also control updates, configurations, and system changes.
Download EU GMP Annex 11 Guide to MES Validation and Lifecycle Change Control Here
Where PAS-X Implementations Create GMP Risk
PAS-X does not create compliance by itself, and inspectors rarely judge an MES by its product name. Instead, GMP risks emerge when companies configure workflows poorly, leave integrations uncontrolled, assign unclear ownership, or fail to maintain validation throughout the system lifecycle.
The table below shows the PAS-X implementation gaps that can turn a capable pharmaceutical MES into an inspection risk:
| Risk Area | Common PAS-X Implementation Gap | What Inspectors Assess |
|---|---|---|
|
Master Batch Record Configuration |
Teams configure incorrect instructions, limits, calculations, or exception rules. |
Approval, testing, version control, and alignment with authorized manufacturing instructions |
|
User Access Management |
Administrators grant excessive access or fail to remove inactive accounts. |
Role-based access, unique accounts, segregation of duties, and periodic access reviews |
|
Audit Trail Governance |
Quality teams collect audit trails but do not review critical changes. |
Audit trail review, investigation of unusual actions, and protection of metadata |
|
System Integration |
PAS-X, ERP, LIMS, or automation systems exchange incomplete or incorrect data. |
Interface validation, data mapping, reconciliation, error handling, and transfer monitoring |
|
Validation and Change Control |
Teams validate the initial system but apply updates without adequate impact assessment. |
Intended-use validation, risk-based testing, regression testing, and documented release approval |
What Evidence Should Be Ready for a PAS-X Inspection
A PAS-X inspection requires more than approved validation documents. Companies should also present current user-access records, audit trail reviews, electronic batch records, change controls, deviation investigations, interface tests, backup evidence, and periodic system assessments. In addition, quality teams must show that employees follow these controls during routine manufacturing. Therefore, a strong inspection-readiness checklist should connect every PAS-X procedure to clear records that prove consistent GMP execution.
The infographic below maps the PAS-X records, review activities, and responsible owners that inspectors expect to see during a GMP inspection.
Final Words
FDA completed 141 Section 704(a)(4) records-request reviews in FY2025, the highest annual total since FY2021. This trend shows that inspection readiness now starts before an investigator enters the site, as regulators can assess validation, data integrity, and manufacturing records remotely.
Therefore, companies using koerber pharma software must keep PAS-X evidence current, traceable, and inspection-ready throughout routine production. Ultimately, strong governance not the MES product name determines whether digital controls withstand regulatory scrutiny.
Digital Solutions for GMP Operations
We support pharmaceutical teams in implementing, maintaining, and optimizing GMP software, data management systems, and computerized workflows that strengthen compliance, data integrity, and operational efficiency.
FAQ
No. PAS-X supports GMP controls, but the manufacturer must validate the system, govern access, control changes, and maintain reliable records throughout its lifecycle.
Inspectors often request electronic batch records, audit trail reviews, user-access logs, validation evidence, change controls, and deviation investigations.
Quality teams should review critical audit trails at a frequency based on data risk, process impact, and batch-release requirements.
References
Reza Esmaeili is a technology and product leader in Germany, combining CTO and CPO experience to bridge engineering execution with customer-driven product strategy. He has led cloud and automation initiatives that improved operational efficiency and reduced costs. He has managed cross-functional teams of engineers and product managers and brought new software products from concept to market. He focuses on building data-driven product organizations by introducing analytics to track performance and guide decisions. He champions Agile ways of working to shorten feedback loops, improve quality, and accelerate go-to-market execution in close partnership with sales and marketing.