MES solutions replace paper-based, slow and error-prone processes in the manufacture of pharmaceutical and biopharmaceutical products. But what exactly are the benefits of digitization for pharma and biotech manufacturers? And how do you find the right MES supplier?
Read more
It’s no question that in the digital age, pharma and biotech production must be supported by MES. These systems digitize end-to-end pharma manufacturing processes – from receiving goods via warehousing to production and packaging.
Read more
As pharma and biotech companies optimize processes, they constantly strive to increase the output of a product while boosting their quality and reducing the share of error-prone manual processes at the same time. Here, AI will playa key role.
Read more
IIoT has become an integral part of manufacturing and should be adopted by the pharma & biotech industry. This involves making important decisions, such as phasing out legacy systems and transforming current business models.
Read more
Many pharma and biotech manufacturers struggle to gain senior level buy-in for MES investments. Whilst corporate IT such as ERP is well understood, not believing in ROI for manufacturing solutions is a major reason why companies have difficulties to eliminate paper GxP records.
Read more
OEE monitoring helps to identify weaknesses in production processes and select suitable optimization measures. Pharmaceutical manufacturers can thus increase the capacity of their existing plants while reducing costs.
Read more
The acronym ALCOA+ has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA+ relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate.
Read more
To deliver Cell & Gene therapy treatments at scale bio-pharmaceutical companies are moving away from complex paper-based documentation, integrating many different electronic systems, and automating previously manual verification processes.
Read more
According to the FDA (“Data Integrity and Compliance with CGMP Guidance for Industry”), data integrity refers to the completeness, consistency, and accuracy of data. In the last years, the FDA has seen an increase in data integrity violations.
Read more
The rapid adoption of new technologies , such as Mobile, Internet of Things (IoT), Advanced Analytics or Cloud, will impact healthcare significantly!
Read more