Our services for the pharmaceutical industry
In pharmaceutical projects, we safeguard computerised systems, data flows and qualified equipment throughout their lifecycle. We translate GxP requirements into robust IT and validation concepts that stand up in inspections and supplier audits. Whether LIMS rollout, ERP CSV or a global chromatography landscape: we know the interfaces between QA, subject-matter experts and IT.
Which service fits your system and your inspection date?
Book an initial callPharma pathfinder
Where does your GxP project start?
Choose the area where your system or equipment sits. You get the matching starting point with a reference and a contact route.
Laboratory and QC: LIMS, chromatography, lab IT
Data integrity assessment for LIMS and chromatography software, hardened lab PCs and access concepts per Annex 11 and Part 11.
Production: equipment, MES and cleanroom
IQ, OQ and PQ for production equipment, HPLC systems and clean utilities, plus evidence for MES and process control systems in ongoing operations.
Validating ERP and interfaces
Risk-based validation of purchased systems per GAMP 5 for EU GMP and FDA. Example: a manufacturing ERP with 500 delivered instead of 1,200 planned hours.
Custom development and bespoke interfaces
Validatable laboratory and production applications per GAMP 5 Category 5 with traceability matrix and Part 11-ready audit trail.
Rollout across multiple sites
Steering LIMS and system rollouts across sites in the DACH region and internationally, in German and English, through to GxP-released go-live.
Pharma, medical technology and food follow different rulebooks, yet ask the same questions about data and equipment. For the pharmaceutical industry, we bundle the services that run from the first gap assessment to the released system.
Reference: AI-supported CSV of a manufacturing ERP for a Canadian pharma manufacturer opening a site in Germany. Read the case story
Typical systems in pharmaceutical GxP environments
From the QC lab to the infrastructure: these are the systems we support in validation, qualification and operations.
LIMS, chromatography, lab IT
LIMS, chromatography software, lab IT and validated spreadsheets with ALCOA+-ready data flows.
Start the Data Integrity Check ›MES, process control, equipment
MES and process control systems as well as production equipment, HPLC systems and clean utilities across the GMP lifecycle.
View equipment qualification ›ERP, interfaces, servers
ERP and interfaces plus the qualified infrastructure of servers, Active Directory and backup.
View IT administration ›Data Integrity Check
Eight questions on audit trails, access rights, raw data and laboratory instruments reveal first fields of action in the QC lab.
Start the Data Integrity CheckAnnex 11 Check
The quick check shows where your computerised systems stand against Annex 11.
Start the Annex 11 CheckKey regulations and standards
The pharmaceutical industry is primarily assessed against EU GMP, national drug law and FDA cGMP. These primary sources frame our consulting:
