Securing manufacturing data has always been a challenge. Ensuring that information gathered from different unit operations taking place at various locations is consistent and accurate is a complex, multi-stage process. The bad news is that on-site data management is likely to get even harder as products and production processes become more complex and the volume of information increases.

The good news says Stephen Goldrick, PhD, lecturer in digital bioprocess engineering at University College London (UCL), is that “industry 4.0” technologies–systems able to gather information from multi step processes–have the potential to help drug makers address data integrity challenges, provided they are set up correctly.

“Maintaining data integrity should become easier as the sector adopts the core principles of Industry 4.0 since this requires investment in better data management infrastructure and hence enables more reliable and consistent data storage that shifts away from error prone paper-based records,” notes Goldrick.

This view is shared by UCL researcher Haneen Alosert, Goldrick’s co-author on a recent paper on data integrity risks, who says 4.0 technologies and regulatory innovation are changing the landscape.

“Complying with data integrity standards is a key part of the quality assurance procedure and helps biopharmaceutical companies ensure the continued product quality, efficacy and safety of their products,” Alosert tells GEN. “Standards such as the FDA’s ALCOA+ guidelines have been released to help those in the biopharmaceutical sector assess and mitigate data integrity risks and avoid costly regulatory product rejections.”

Quality checks

The extent to which 4.0 technologies can help drug companies secure data will depend on how well they are implemented and the IT infrastructure that is established.

“A 4.0 type manufacturing line relies on computerised systems that pose some data integrity challenges to produce compliant data,” says Goldrick. “Software must be quality checked, verified, and validated to ensure they are suitable for manufacturing within GxP environments.”

For drug makers with digital savvy, blockchain technology is a potential solution, he continues.

“Blockchain can play a role in data integrity as information from manufacturing environments could be stored within the blockchain as an incorruptible digital ledger that ensures data traceability, transparency and security,” Goldrick explains. “However, the first step for the biopharma sector is to stop recording information using a pen and paper and then we can consider more advanced solutions such as the blockchain.”

Drug companies that use 4.0 technologies to secure internal data also need to consider external risks, according to Suzanne Farid PhD, who worked with Alosert and Goldrick on the study.

“Cybercrime could be more of a risk for 4.0 manufacturing technologies as all cloud-based technologies and storage are more vulnerable to security breaches and, therefore, require better cyber-security measures to ensure the data is safe, accessible, and uncorrupted,” she says. “Also, if the company truly moves towards Industry 4.0 and invests in the Industrial Internet of Things (IIoT), where all devices and sensors within every physical unit operation are interconnected, the risk to cyber threats could increase.”