Siemens: Inspectors quick to adapt to digital batch records

Moving from paper to electronic batch records can help manufacturers improve traceability, rapidly overcome processing issues, and ultimately commercialise medicines faster at lower costs, Siemens’ industry software project manager Nicolas Teissié told delegates last week.

According to good manufacturing practice (GMP) regulations​, drugmakers must prepare and maintain batch production records for each manufacturing process. These reports improve the visibility of the quality assurance (QA) system, and are regularly referred to during site inspections.

But at the Adents Serialization Innovation Summit in Paris, Teissié said drugmakers can be more reluctant to adopt electronic records than inspection authorities.

“We have some customers that are still asking for printing ‘just in case’, to be able to show authorities,” ​said Teissié.

However authorities are more than capable of understanding electronic records, particularly when they demonstrate improved QA, he added, and “as software providers, we are also doing our homework…to keep up the pace with new regulations.”​

Teissié’s colleague Andrew Whytock, who heads up digitalisation and innovation in Siemens’ pharmaceutical business sector, agreed that authorities are leading the charge in terms of digitisation.

Industry is seeing a “pull from the regulators”​ towards digitisation, he told delegates.

“A long way to go”​

According to Teissié, industry is still a way off switching to a completely paperless system.

“The reality is that today, around 80% of facilities don’t have an electronic system to track production.”​

Therefore with just 20% of manufacturing sites employing electronic systems, “there is a long way to go, before going paperless,” ​he added.