Home › Case Stories
Case Stories

Reference projects you can inspect

Eighteen GxP case stories, grouped by the six service areas.

Overview

18 case stories across six service areas

Each tile opens the case story. Manufacturer pages sit on the individual stories. Filter by service area, industry or keyword.

Service area

Industry

18 case stories

Data Integrity Consulting

Readability, archives and gap assessments on validated landscapes, before data or hardware leave the yard.

Historical laboratory data being converted into open formats Data Integrity Consulting

Data readability

Legacy cell analyser as a VM plus conversion of cell-punch files into open formats.

Read the case story GxP data archive and restore rehearsal in the laboratory Data Integrity Consulting

Data archiving

GxP archive and restore rehearsal before laboratory hardware leaves the yard.

Read the case story Process control room during a data-integrity gap assessment Data Integrity Consulting

DI gap assessment

A food manufacturer landscape plus a gap assessment on validated GxP software: until the findings were closed.

Read the case story

Equipment and Facility Qualification

Instruments, production equipment and suppliers, through release, FAT/SAT and inspection.

Qualification of a spectrophotometer in a GxP laboratory Equipment and Facility Qualification

NanoDrop One qualification

Spectrophotometer GxP-released in four months, including PCR instruments and Validation Manager.

Read the case story Qualification of tablet presses and extruders Equipment and Facility Qualification

Presses and extruders

Retrospective qualification of a tablet press and FAT/SAT plus on-site qualification of extruders, no client names.

Read the case story Supplier qualification ahead of an FDA inspection Equipment and Facility Qualification

FDA-ready supplier qualification

Unnamed food manufacturer: gap analysis, supplier qualification, passed FDA inspection.

Read the case story

Computer System Validation (CSV)

CSV against Annex 11, validated spreadsheets and periodic reviews of computerised systems.

CSV of an ERP system against EU GMP Annex 11 Computer System Validation (CSV)

SYSPRO CSV against Annex 11

Canadian pharmaceutical manufacturer, new site in Germany: AI-supported CSV delivered in 500 hours instead of the 1,200 hours planned.

Read the case story Validated spreadsheets for sample management in the QC laboratory Computer System Validation (CSV)

ESSV sample management

Validated spreadsheets for laboratory stock and around 100 temperature loggers: audit trail, AD users, SQL Server.

Read the case story Periodic review of a process control system in pharmaceutical production Computer System Validation (CSV)

Periodic review of a process control system

Up to 600 change requests a year from MS Access into TrackWise: annual Q1 close in human pharma production.

Read the case story

IT Administration

Operation, connectivity and hardening of laboratory and production systems, from island stacks to central admin.

Microplate software linked into a LIMS in the QC laboratory IT Administration

SoftMax Pro ↔ LabWare

Automated QC results from SoftMax Pro V7.2 and connected analysers into LabWare LIMS V8.

Read the case story HPLC laboratory with central Chromeleon administration IT Administration

Chromeleon global admin

Four island labs, six servers, 300 users, Mexico: one Chromeleon estate.

Read the case story Virtualised laboratory systems in a data centre IT Administration

System virtualisation

Proxmox and VMware retention so decommissioned lab systems stay bootable.

Read the case story Hardening and qualification of a spectrophotometer IT Administration

Spectrophotometer lab IT

Kiosk mode, PowerShell audit trail, backup and virtualisation of the vendor software: instrument unnamed.

Read the case story Change control for decommissioned laboratory PCs IT Administration

70 laboratory PCs

Master change control for stored Quality PCs: migration, archiving or virtual machine: 70 units in one year.

Read the case story

Project Management

PMO, rollouts and CAPA when many systems, sites and quality assurance have to move together.

LIMS rollout and project control in a laboratory war room Project Management

LabWare LIMS rollout

LabWare V8.0 for around 400 users plus a global SAP update: PMO, requirements and change management.

Read the case story CAPA and change documentation after a system deviation Project Management

CAPA after a system deviation

Critical GxP deviation: root cause, correction, prevention, QA close-out and SOP.

Read the case story

Software Development

Custom builds and migrations that stay in GxP daily use, from an Access frontend to a resource planner.

Laboratory workstation with a web-app interface on the monitors after the Access migration Software Development

Access to web app in under 270 hours

A grown MS Access frontend became a multi-user web app: same scope, under 270 instead of more than 2,500 estimated hours.

Read the case story Project control with a global resource planner Software Development

Resource planner (global)

Server app with browser UI and database: staff hours, project assignment, tailored user management.

Read the case story

A similar case story in your lab?

Tell us which system is leaving, drifting or still writing drop files.

Contact us