Regulated industries · Food industry

GxP and quality assurance for the food industry

Quality-critical IT, process data and technical equipment in hygienic production environments: traceable controls, robust documentation and risk-based qualification.

Our services for the food industry

In food production, we support quality-critical IT, process data and technical equipment. The focus is on traceable controls, reliable documentation and risk-based qualification and validation approaches. HACCP, hygiene regulations and FDA Preventive Controls demand the same robust evidence as in pharma, only with different primary sources.

DI gap assessments for sample management, temperature loggers and production data with traceable audit trail and access control.
Validatable applications for sample management, logger evaluation and production support with documented lifecycle.
Change control, archiving and hardened lab PCs for long-term readable production and quality data in hygienic environments.
FAT, SAT and on-site qualification of presses, extruders and production equipment with robust IQ, OQ and PQ documentation.
Validation of MES, process control systems and lab IT with risk-based evidence for HACCP-critical control points.
Steering equipment qualification, system rollouts and change programmes across production and quality functions.

Which service fits your production line and your next audit?

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Food pathfinder

Where does your food project start?

Choose the area where your equipment, system or supplier sits. You get the matching starting point with a reference and a contact route.

We connect food law with CSV, equipment qualification and data integrity so production lines, lab IT and supplier networks remain auditable, without presenting pharma rulebooks as food-specific obligations. For the pharmaceutical industry and medical technology we map regulations on dedicated pages.

Reference: Supplier qualification at a food manufacturer with gap analysis, authority preparation and a successfully passed FDA inspection. Read the case story

Typical systems in food production

From the production line to the archive: these are the systems we support in validation, qualification and operations.

Production

Equipment, MES, process control

Presses, extruders and production equipment as well as MES and process control systems at HACCP-critical control points.

View equipment qualification ›
Lab and quality

Sample management, loggers, lab IT

Sample management, temperature loggers and lab IT with a traceable audit trail and access control.

Start the Data Integrity Check ›
IT and archive

Lab PCs, change control, archiving

Hardened lab PCs, change control and archiving for long-term readable production and quality data.

View IT administration ›
GxP

Supplier Qualification Quick Check

Eight questions identify initial action areas covering risk classification, quality management, personnel, the software lifecycle and support.

Start the Quick Check
ALCOA+

Data Integrity Check

Eight questions on audit trails, access rights, raw data and laboratory instruments reveal first fields of action in the quality lab.

Start the Data Integrity Check

Key regulations and standards

Food manufacturers align with EU hygiene law, national food codes and FDA Preventive Controls. These primary sources frame our work:

FAQ: GxP advisory for the food industry

Do food manufacturers need CSV and data integrity?
Yes, whenever electronic records are production or quality relevant. HACCP, EU hygiene law and FDA Preventive Controls require traceable process and test data. We deliver DI assessments, CSV and IT administration with a defensible audit trail.
Which regulations apply to data integrity in food production?
Key sources are Regulation (EC) No 178/2002, Regulation (EC) No 852/2004, LFGB and FDA 21 CFR Part 117. For electronic systems we also apply Annex 11 and Part 11 principles without presenting pharma norms as food-specific obligations.
Do you qualify production equipment in the food industry?
Yes. We perform FAT, SAT and on-site qualification of presses, extruders and production lines, including IQ, OQ and PQ documentation. See Equipment and Facility Qualification for details.
How do food projects differ from pharma at cube one?
Primary sources and audit focus differ (HACCP instead of drug law), but the questions about data and equipment are similar. We use the same service building blocks while mapping regulations industry by industry, as described on this food page.
Where can I find food case stories?
Examples are listed below on this page. The filtered overview of all food references is at food industry case stories, for example press qualification, ESSV sample management or change control for lab PCs.

Reference projects

Selected case stories from the food industry and adjacent regulated environments.

Show all case stories for the food industry

Discuss your food industry project

Speak with our advisory team about qualification, CSV or data integrity in your production environment.

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