The pharmaceutical industry operates in a highly regulated environment where traceability and compliance with regulatory requirements are critical. By digitalizing production with modern MES solutions, pharmaceutical companies can meet these demands more efficiently – while also improving productivity, reducing risks and gaining a competitive edge.
At Metronik, our years-long work with nearly thirty pharmaceutical manufacturers resulted in development of the MePIS LS MES system, which is specifically tailored to the needs of the pharmaceutical industry. It combines comprehensive production digitalization with the highest standards of compliance, safety and quality. This helps pharmaceutical companies achieve their goals for quality, safety and sustainability at every stage of production.
At the same time, we are already developing the next generation of solutions – integrating artificial intelligence to bring even greater levels of efficiency and reliability to manufacturing operations.
Digitalization in a GMP environment – more than just going paperless
Digitalizing production in a GMP environment means much more than simply moving to paperless documentation. Modern MES systems provide full digital recording of production processes (Electronic Batch Records – EBR), automated data capture and support for ALCOA+ principles.
This means that data must always be Attributable (to a responsible person), Legible, Contemporaneous (recorded in real time), Original and Accurate. ALCOA+ extends this with additional requirements that data must also be Complete, Consistent, Enduring and Available – ensuring data integrity throughout the entire lifecycle.
By implementing MePIS LS MES, pharmaceutical companies gain:
- Complete real-time traceability of batches, materials and equipment
- Reduced data entry errors thanks to automated data capture from equipment and systems
- Faster detection and control of deviations, enabling real-time response and lowering the risk of final product defects
- Simplified validation of manufacturing processes through digital workflows and electronic task control
- Greater efficiency, as paperless processes shorten batch documentation preparation and closure times.
In this way, digitalized production doesn’t just simplify documentation – it delivers comprehensive improvements in quality, safety and production efficiency.
MePIS LS MES as a foundation for regulatory compliance
MES systems are key components for ensuring compliance with international regulations and standards such as GMP, EU GMP Annex 11, 21 CFR Part 11 (FDA) and GAMP 5.
The MePIS LS solution enables:
- Secure management of electronic signatures that confirm critical process steps in accordance with regulatory requirements
- Automated creation and storage of audit trails that log all data and process changes in a way that prevents unauthorized access or tampering
- Greater transparency, standardization and control over process execution, which simplifies audits and inspections
- Support for process validation, with clear oversight and traceable repeatability of procedures
- Reduced administrative workload by replacing manual entries and checks with automated, validated functionalities.
In this way, MePIS LS not only ensures compliance with strict regulatory demands but also builds trust among regulators, business partners and customers in the safety and quality of pharmaceutical products.
Digitalization as a foundation for the future
Digitalizing production with MES systems in the pharmaceutical industry delivers much more than a paperless environment and compliance.
It enables comprehensive real-time data management, faster and safer Automatic Batch Release (ABR), reduced errors and increased flexibility and efficiency in production processes.
Pharmaceutical companies that invest in digitalization are not just meeting regulatory requirements – they’re laying the foundation for growth, innovation and long-term business success.
