
Situation
A company is operating a complex production in a regulated environment. Due to a lack of data collection there is limited opportunity to control production. Many systems are linked to production which is adds to the difficulty of collecting and organizing production data.
Challenges
The system must support GMP requirements for ER/ES (electronic records/electronic signatures).
Management want to be able to see how much additional potential there is in the current proposed production solution.
Management also need to be able to see long-term, i.e. future production potential beyond resolving the current issues faced.
Success
An ideal solution will help the company to…
(1) Comply with regulations (e.g. traceability) and meet data integrity requirements.
(2) Collect and centrally store production and process data enabling:
- Fast and accurate analyses
- Maintenance mapping
- Key performance indicator (KPI) follow-up
- Decision support for driving efficiency improvements
Solution
- A scalable and future-proof production information solution meeting regulatory requirements.
- By starting with a pilot installation the company can generate value early and reduce risk. The solution can then be rolled out to other equipment.
- Opportunity to exploit the full potential of production data collection.

Production performance – OEE/TAK:
– Collection of production data, e.g. production yield
– Visualization in various formats, e.g. web browser, touchscreen, large-screen monitor
– Production planning and visualization of order flow
– Generation of KPIs, e.g. OEE/TAK, MTBF, MTTR, etc.
– Basis for preventive maintenance and continuous improvement programs