A single misstep or oversight can cascade into a catastrophic failure, resulting in financial losses, wasted time — not to mention those worst-case scenarios like product recalls and fatalities. The stakes are high, not only in terms of monetary value but also in safeguarding public health and upholding the reputation of pharmaceutical manufacturers.
Paper-based processes
Among the biggest challenges in pharmaceutical production is an ongoing reliance on paper-based systems. Physical documents, log books and forms to record critical data are often used to track information on raw materials, equipment use, quality control and production stages. These highly critical files are regularly stored in physical binders or filing cabinets.
These paper-based processes pose inherent risks to data integrity. Manual transcription can lead to inaccuracies, which can compromise quality and safety of products. Moreover, handwritten records are susceptible to illegibility and could be challenging to interpret. That’s not to mention the time spent on processing paper-based documents, which costs companies an estimated $19.7k per worker, per year according to Apprentice.io research. For big pharma, this cost can be colossal.
The days of relying on manual, paper-based documentation are numbered. The industry is recognizing the issues of these methods and exploring digital tools to improve data integrity. In fact, the Food and Drug Administration (FDA) has been executing its own campaigns to encourage the transition to electronic or partially-electronic processes since 2002.
The initial FDA campaign was largely driven by the slowdown in availability of innovative pharmaceutical products. According to one study, the cost of bringing a drug to market increased four-fold between 1990 and 2001. During the same period, time-to-market increased from eight to ten years to ten to twelve years. More recently, a study in 2020 estimated that the median cost of developing a new drug was $985 million, and the average was $1.3 billion. The reason for the ever-increasing cost of drug development is thought to be a combination of inefficiencies throughout the product development process, as well as increased regulation.
Regulation drives digitalization
It is impossible to discuss the transition to electronic processes without considering regulatory compliance. Regulations such as FDA 21 CFR Part 11 and EU GMP guidelines Annex 11 serve as the bedrock on which pharmaceutical production operates — and digitalization can only be achieved with these standards in mind.
FDA 21 CFR Part 11 ensures that all data sets are complete, consistent and trustworthy. This uses the guiding principles of ALCOA+ — this acronym represents attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
EU GMP guidelines Annex 11 outlines the requirements for computerized systems used in pharmaceutical manufacturing, focusing on risk management, validation, audit trails, data integrity, security, change control, incident management, training and outsourced activities. It emphasizes the need for validated systems with secure audit trails, robust data integrity measures and stringent security controls to prevent unauthorized access or tampering. Unsurprisingly, manually written and stored documents often fall short of both of these requirements.
When selecting digitalization tools for the transition to electronic documentation, any old software will not do. Pharmaceutical manufacturers must opt for industry-specific platforms that can address the complex regulatory landscape of the sector.
An effective software provider will understand the regulations and standards set forth by regulatory bodies such as the FDA, European Medicines Agency (EMA) and others worldwide, and encompass Good Manufacturing (GMP) practices and data integrity requirements.
GMP provides a set of quality assurance guidelines and procedures aimed at ensuring pharmaceutical products are consistently produced and controlled to meet quality standards. GMP covers various aspects of production and quality control, including personnel, facilities, equipment, documentation, production processes, quality control and testing.
COPA-DATA’s zenon provides full compliance with these regulations and standards out of the box.
Digitalized documentation in action
Digitalization can become the linchpin that guarantees the quality, safety, and consistency of pharmaceutical products. Outside of regulatory compliance and data integrity, effective deployment of digital software platforms can improve other areas of production, ultimately resulting in improved quality.
Quality Control (QC) testing is another critical aspect of pharmaceutical production. From raw materials to finished products, rigorous testing protocols are implemented to detect any deviations from predefined quality parameters. By digitizing QC processes, companies can enhance efficiency, accuracy and traceability.
Complementing QC efforts, Quality Assurance (QA) systems provide a framework for continuous improvement and adherence to quality standards. These systems act as a safeguard, ensuring that production processes consistently deliver products of the highest caliber. Validation and qualification further bolster the foundation of quality management and digital solutions can facilitate this validation process, offering robust tools for data analysis, documentation and audit trails.
This level of digitalization can be achieved through deployment of intelligent software that can communicate across a range of equipment — regardless of the age, manufacturer or communication protocol. In fact, this connectivity can expand from the production facility, to the lab and even wider supply chain, ensuring quality from product inception to consumption.
In pharmaceutical production, stringent regulations provide a solid foundation for quality and safety. However, reliance on outdated paper-based processes undermines these efforts. The transition to electronic documentation is not only necessary for efficiency but also vital for compliance with regulations, quality management and patient safety.
Industry-specific digitalization tools, such as COPA-DATA's zenon, offer tailored solutions to address these challenges.
Discover zenon here.