In an age where precision in manufacturing is far more achievable than ever before, embracing the available solutions in line with guidelines laid down by Pharma 4.0 is essential for all companies in validated industries.
The digital transformation offers new and innovative processes, such solutions must serve their purpose in a compliant manner. In an industry which cannot tolerate room for ambiguity, compliance to these regulations must be built into a system’s design and function.
Paper-based forms have many drawbacks, but data leakage is rarely an issue. As the industry moves towards IIoT, it is faced with new challenges in terms of data security. Compliance, while becoming tighter, has also been made more complex.
Data protection is now a key component of GMP in a way that it hasn’t been previously. It is essential that companies within the industry find a way to balance digitized and automated processes with strict compliance laws. Getting this balance right will result in increased productivity, greater batch consistency and fewer compliance issues.
One of the major issues facing pharmaceutical companies when it comes to batch accuracy is the complexity of their manufacturing processes. Precision and consistency are key for product efficacy and safety. But with complex processes comes increased opportunity for errors. These errors can lead to manufacturing delays, production and quality losses, and costly compliance breaches. Review by exception and computer assisted review can provide remedial action to take place before expensive mistakes are made to ensure production remains efficient and compliant.
Despite the regulatory risks associated with data entry errors and audit trails, many in the pharmaceutical industry are still relying on paper records and manual data entry, putting their operation at risk. Digital logbooks can be authored to ensure every step of the process is recorded and every batch has a simple audit trail.