With OPRA, the pharmaceutical manufacturer Engelhard meets the strict compliance regulation in its sector. Engelhard Arzneimittel GmbH & Co. KG from Niederdorfelden in Hesse has been a SAP user for some time. However, the Plant Maintenance Module has not been used sor far. Instead, the company recorded working hours at the machines via its production system, while the maintenance processes for the packaging, filling and labelling machines were traditionally handled on paper.
“Our previous type of maintenance was no longer compatible with the high compliance requirements, particularly in the pharmaceutical sector, in the long term,” explains Christian Belzer, Deputy Head of Plant Engineering at Engelhard Arzneimittel.
The machines are full of precision mechanics, and there is a latent danger that vials or package inserts might get stuck. That is why strict maintenance is essential, which must be cleanly documented and is regularly audited by external auditors. It was expected that carrying out these processes in the SAP system and no longer on paper lists would lead to better traceability, more clarity for the examiner and thus the fulfillment of all current compliance regulations.
The manufacturer then comissioned DATAGROUP to introduce SAP Enterprise Asset Management (EAM) and OPRA (Optimized Proactive Lifecycle Approach), DATAGROUP’s SAP-based application for the maintenance of mobile and stationary systems and devices.
OPRA complements the EAM module with user-friendliness, process orientation and seamless integration of third-party systems and enables a technical, functional and visual integration of assets, people, processes, data and systems into SAP. In a first analysis workshop, Engelhard’s internal processes were examined and discussed how SAP EAM had to be adjusted as well as how to work with OPRA. The company’s controlling department as well as the IT and process management department were colsely involved, because in the end, maintenance is also about costs that can be saved through automated, well-documented procedures.
Automation is the keyword: Engelhard has to carry out a whole series of maintenance steps repeatedly according to a specified cycle and pattern. These can be easily defined, processed, and, above all, docmented in a comprehensible manner with OPRA. This ensures that each inspection really does take place at the prescribed time. In SAP, all results are clearly documented and is possible to prove exactly when what was done – a dream for every auditor.
OPRA was introduced in spring 2017, the pilot took place in September and the solution has been running productively since the beginning of October 2017. Maintenance staff at Engelhard Arzneimittel currently work with the solution, almost all of them with the mobile version, i.e. they have installed the maintenance tool on their tablets. Only one desktop workstation was set up.
“Our maintenance staff should be as close as possible to the units and always have their tablet with them,” explains Christian Belzer. Next, Engelhard Arzneimittel is planning to expand OPRA with additional modules. For example, it is planned to introduce the OPRA Reporting module in order to be able to make secure decisions based on valid KPIs and reports and to strategically develop maintenance.
Holistic, SAP-based solution for:
What began in 1872 as a pharmacy is today – 145 years later – an internationally operating company with about 400 employees. As one of the leading brand manufacturers in the OTC sector, Engelhard Arzneimittel primarily sells pharmacy-only medicines for self-medication. The company’s core competencies are respiratory tract therapeutics and drugs for skin diseases.
Products such as Prospan® and isla® have always stood for high quality. With research and quality assurance into the active ingredients from ivy leaves in the product Prospan®, Engelhard Arzneimittel has set standard for rational phytotherapy for respiratory diseases.