Sheba Zaman, Head of Product Specialists and Training Services at Novatek International, is featured on the podcast to discuss how technology can provide visibility and powerful decision making for contamination control in pharmaceutical manufacturing. She explains the difficulties in the industry of digitalizing due to regulations, product safety and taking liability into account. Additionally, she discusses how utilizing data lakes and connecting elements of contamination control can provide insight and trend analysis.
Connecting Data to Improve Your Contamination Control Strategies
In the pharmaceutical industry, managing compliance data, particularly in contamination control, is a daunting task. However, technology can provide a holistic approach to ensure data integrity and compliance while enhancing efficiency. In a recent episode of the Exceeding Your Benchmark podcast, Sheba Zaman, Head of Product Specialists and Training Services at Novatek International, shares her insights on connecting data to improve contamination control strategies. Here are some key takeaways from the episode:
The Challenges in Managing Compliance Data
One of the biggest challenges in managing compliance data in contamination control is the hesitancy to move towards digital solutions. The pharmaceutical industry needs to take into account regulations and potential liabilities to ensure product safety and patient health. As a result, many pharmaceutical manufacturers still have data silos, where different systems manage different aspects of the process, and data analysis is done manually or in a hybrid approach. According to Sheba, companies need to move from digitization to digitalization, where they take advantage of technological tools to analyze their processes fully.
“If you improve that process and connect all the elements of contamination control, you have the ability to really get insight into your process, get insight into potential improvements, or into incidents when they do occur,” Sheba says.
Moreover, there is not a single solution for managing contamination in manufacturing processes, and companies need to consider a holistic approach to ensure data integrity and compliance. However, many companies are still struggling with interconnected compliance systems. One common mistake that pharmaceutical manufacturers make is documenting their user requirements too specifically, without considering the purpose of the requirement. According to Sheba, user requirements should be written generally to allow engineers to design the best way to satisfy that requirement.
Addressing Concerns around Data Integrity and Compliance Regulations
With digital transformation, pharmaceutical manufacturers are concerned about data integrity and compliance regulations. According to Sheba, companies need to mitigate the risks of data integrity, particularly cybersecurity. They also need to conduct a data integrity risk assessment and validate the system to ensure compliance with data integrity requirements. Sheba emphasizes that the validation process needs to cover exactly how companies will use the system and identify the risks of data management specific to their process.
To address concerns around changing compliance regulations, companies need to consider a future-oriented approach to their user requirements. They should focus on the future process and envision their requirements, rather than transferring their existing process into a computer solution. This approach enables companies to identify the best solution to satisfy their requirements and improve their process.
The Future of Digital Transformation in the Pharmaceutical Industry
The pharmaceutical industry is behind other industries in digital maturity, but there is a lot of room for improvement. Sheba predicts a massive transformation in the industry, with increased automation of contamination control processes. The future of the industry is automation, where manufacturing processes become leaner, and companies predict problems before they occur. With increased automation, humans will be used more in decision-making and analysis, and less in the input portion of data. Sheba believes that technology can provide the pharmaceutical industry with good automated contamination control that will help in the future improvement of the industry.
In conclusion, managing compliance data in contamination control is challenging, but technology can provide a holistic approach to ensure data integrity and compliance. Companies need to move from digitization to digitalization, address concerns around data integrity and compliance regulations, and focus on a future-oriented approach to their user requirements. The pharmaceutical industry has a lot of room for improvement, and the future of the industry is automation.
As Sheba notes, “It certainly is worth it in the end. And it’s also inevitable. In order to beat out your competitors it is a road that you must go down.”