Xylem Analytics Germany Sales GmbH & Co. KG

https://www.xylemanalytics.com

Nov 12, 2026

How long does it take for a new instrument to be released in your GxP environment?

Data integrity deficiencies appear in roughly 60 to 80 percent of pharmaceutical GMP warning letters. The FDA issued 303 drug warning letters in fiscal year 2025 - a 59 percent increase from the year before. The most common findings: disabled audit trails, shared logins, backdated records and missing audit trail reviews. Every instrument that is not GxP-compliant from the start costs release time and increases audit risk.

The MultiLab® Pro IDS from Xylem is GxP-compliant from day one - fully compliant with 21 CFR Part 11, GMP and GLP.

Audit trail integrated: Every change and access is logged and traceable - who changed what, and when. The original value is preserved. The audit trail is not only technically present but genuinely reviewable. This addresses one of the most common audit findings directly: audit trails that are configured but not reviewable.

Electronic signatures with legal validity: Handwritten signatures are replaced by electronic ones with full legal validity. Approvals are legally documented - without the paper detour.

User roles and password policies: User roles, password policies and authentication systems protect against unauthorized access. No shared logins, no gray areas. This eliminates another frequent audit finding: shared user accounts.

Tamper-proof data storage: Electronic data is stored in a tamper-proof manner. Manipulation or deletion without traceability is excluded. Data integrity is secured by design.

Compliance is not a retrofit problem in the MultiLab® Pro IDS. It is built in - from day one. So pharma and QC labs have no open questions at the next inspection.

👉 More on GxP compliance with the MultiLab® Pro IDS