Service

MES Implementation

We lead MES programs from discovery and fit-gap through configuration, qualification and hyper-care - across Rockwell PharmaSuite, Werum PAS-X and Apprentice.

Business Challenges
  • Paper-based batch records slowing release
  • Manual deviations and human error
  • Limited real-time production visibility
  • Difficult integrations with ERP and historians
Solution Overview

A proven MES delivery framework covering URS, vendor selection, S-88 recipe design, integration to SAP / LIMS / historian, CSV-aligned qualification and trained super-users.

Technology Expertise
Rockwell PharmaSuiteWerum PAS-XApprenticeOSIsoft PIOPC UA
Benefits

Outcomes that compound.

Real-time production visibility

Reduction in human error

Faster batch release & compliance

Paperless, electronic batch records

Process

A delivery model engineered for regulated industries.

01
Step 01

Discovery Workshop

Process mapping, URS and site readiness assessment.

02
Step 02

Fit-Gap & Selection

Vendor evaluation, fit-gap analysis and TCO modelling.

03
Step 03

Design & Build

S-88 recipes, integrations, master data and UX configuration.

04
Step 04

Qualify & Go-Live

IQ/OQ/PQ, training, hyper-care and continuous improvement.

Compliance & Standards

Built to pass inspection.

ISA-88 / ISA-95GAMP 5EU Annex 11US FDA 21 CFR Part 11
Key Outcomes
  • Up to 60% reduction in batch review time
  • Right-first-time batches above 98%
  • Compliant, paperless manufacturing
FAQ

Frequently asked questions.

Rockwell PharmaSuite, Werum PAS-X and Apprentice - across solid dose, biologics and cell & gene.
Let's build

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