Securing manufacturing data has always been a challenge. Ensuring that information gathered from different unit operations occurring in various locations is consistent and accurate is a complex, multi-step process. The bad news is that on-site data management is likely to become even more difficult as products and production processes become more complex and the volume of information increases.
The good news, according to Stephen Goldrick, PhD, lecturer in digital bioprocess engineering at University College London (UCL), is that “Industry 4.0” technologies – systems capable of gathering information from multi-step process – have the potential to help drug manufacturers manage data integrity. challenges, provided they are configured correctly.
“Maintaining data integrity is expected to become easier as the industry embraces the fundamentals of Industry 4.0, as it requires investment in better data management infrastructure and therefore enables more reliable data storage. and consistent that moves away from error-prone paper records,” notes Goldrick.
This view is shared by Haneen Alosert, a researcher at UCL and co-author of a recent article on data integrity risks, who argues that 4.0 technologies and regulatory innovation are changing the landscape.
“Adhering to data integrity standards is a key part of the quality assurance process and helps biopharmaceutical companies ensure the continued quality, efficacy and safety of their products,” Alosert said. GEN. “Standards such as the FDA’s ALCOA+ guidelines have been published to help biopharmaceutical players assess and mitigate data integrity risks and avoid costly regulatory product rejections.”
The extent to which 4.0 technologies can help pharmaceutical companies secure data will depend on the quality of their implementation and the established IT infrastructure.
“A 4.0-like manufacturing line relies on computerized systems that have data integrity issues to produce compliant data,” Goldrick explains. “Software quality must be checked, verified and validated to ensure it is suitable for manufacturing in GxP environments.”
For digitally savvy drugmakers, blockchain technology is a potential solution, he continues.
“Blockchain can play a role in data integrity because information from manufacturing environments could be stored in blockchain as an incorruptible digital ledger that provides traceability, transparency, and data security,” says Goldrick. “However, the first step for the biopharmaceutical industry is to stop recording information using pen and paper, and then we can consider more advanced solutions such as blockchain.”
Pharmaceutical companies that use 4.0 technologies to secure internal data must also consider external risks, according to Suzanne Farid PhD, who worked with Alosert and Goldrick on the study.
“Cybercrime could be a greater risk for Manufacturing 4.0 technologies, as all cloud-based technologies and storage are more vulnerable to security breaches and therefore require better cybersecurity measures to ensure that data are safe, accessible and uncorrupted,” she said. said. “Additionally, if the company truly moves towards Industry 4.0 and invests in the Industrial Internet of Things (IIoT), where all devices and sensors in every physical unit are interconnected, the risk of cyber threats could increase.”