Quality compliance in the digital era

Quality compliance in the pharma industry is foundational to guaranteeing safe and effective products. For years, Good Manufacturing Practices (GMP) have served as the guiding framework for maintaining high standards in the production of medicines and medical devices. Compliance requires meticulous documentation and adherence to strict guidelines, which are crucial for maintaining product quality.

Commitment to GMP ensures product consistency and quality through a focus on all aspects of production, including products, people, processes, procedures, and premises. As the industry advances, the need to align these traditional practices with modern technologies has grown exponentially. The digital transformation of GMP is not just an upgrade; it’s a revolutionary shift that offers significant benefits while presenting new challenges.

The growing digitalisation of quality compliance is a strategic imperative

Quality compliance has always been the backbone of the success and reputation of any organisation in the pharma sector. Organisations with exceptional quality compliance systems position themselves as gamechangers in the marketplace. Keeping a continuous check on product quality is an enormous task and involves various systems and a trained workforce.

Years ago, all compliance-related activities were manual and paper-based. Now, digital quality compliance combines modern digital methodologies and tools with established quality assurance and control procedures. Its objective is to maintain the accuracy, consistency, and accessibility of data throughout its entire lifecycle. Digital compliance, in this context, refers to the use of modern technologies, such as cloud-based systems, artificial intelligence (AI)-driven analytics, and automated tools, to maintain quality control throughout the pharma manufacturing process, which benefits organisations and their GMP tenfold.

Digitalisation’s positive impact on quality compliance

The digitalisation of the pharma industry has introduced critical improvements that directly impact pharma quality and efficiency. When implemented strategically, these benefits – including increased efficiency, improved accuracy, and cost savings – are shared across pharma manufacturers and their stakeholders. It’s essential for organisations to understand and harness strategies that can take quality and compliance to the next level. Data integrity, digital quality management systems, predictive quality control, and streamlined regulatory submissions are among the significant advantages digitalisation offers.

Data integrity is the foundation of quality compliance in GMP and ensures the information collected and stored is accurate, complete, and reliable. In the past, manual data entry processes increased the risk of transcription errors, incomplete records, and mismanagement of critical information. With digital systems, data collection and analysis can be automated, reducing human intervention and increasing real-time accuracy.

Digitalisation has enhanced the data integrity process. The US Food and Drug Administration (FDA) defines data integrity as complete, consistent, and accurate data. It provides the framework that “data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).” Achieving this goal requires organisations to follow the key principles of data integrity to retrieve accurate and beneficial insights. One example of digitalisation in real-time data recording is the use of electronic batch records (EBRs), which have replaced traditional paper-based documentation. EBRs offer secure, traceable digital records that significantly reduce the risk of tampering or misfiling. EBRs offer a centralised repository for all production data, from raw material inputs to final product testing results.

Electronic document management systems (EDMS) securely maintain records and help ensure compliance with regulatory standards. Technologies like blockchain and advanced analytics can improve data traceability and transparency throughout the pharma supply chain. Other examples of data integrity are seen in real-time testing results, stability data generation, and consistent backup and recovery plans.

Digital quality management systems (QMS) offer a comprehensive approach to overseeing compliance throughout the manufacturing process. QMS includes document control, training management, change control, corrective and preventive actions, audit management, risk management, and vendor management. Commonly used EDMS tools in the pharma industry include Master Control, Documentum, Laboratory Information Management System (LIMS), Veeva Vault, SAP Quality Management, and SharePoint. Electronic document management streamlines the management of standard operating procedures (SOPs), work instructions, and other essential documents, ensuring controlled updates, revisions, and approvals.

Most of the digital tools used in pharmaceutical industry provide a cloud-based solution with built-in regulatory compliance. Training is essential to a pharma QMS, ensuring that all team members are properly equipped for their roles, and are educated and certified on current procedures, regulatory standards, and guidelines. Using EDMS, learning management systems (LMS), and digital collaboration tools, organisations can create a centralised repository for all quality documents. Change controls systems manage and track changes in processes, products, and systems to maintain quality and compliance. In the event of deviations, including out of trend (OOT) and out of specifications (OOS), quality assurance teams can identify a root cause and address issues with accurate, corrective, and preventive actions. In the case of a product recall or investigation and audits, companies can access detailed, timestamped records quickly. This ease of data retrieval and audit trails helps manufacturers prove compliance with GMP standards.

Further supporting the success of electronic systems, Code of Federal Regulations 21 CFR part 11 enables life science companies to set up an FDA-compliant digital QMS. It permits the use of electronic records and e-signatures in place of traditional paper documents for applicable records as provided in the FDA guidance, Part 11, Electronic Records; Electronic Signatures – Scope and Application. The FDA regards electronic records, systems, and signatures as dependable and credible, holding them to a similar standard as paper records and handwritten signatures.

Predictive quality control (PQC) combines advanced process control (APC) and QMS technologies to enable organisations to foresee potential quality issues before they occur, further enhancing pharma product quality. PQC analyses past and real-time data in combination with proven pharma expertise to predict deviations or failures before they impact product quality or compliance. Pharma organizations that commit to PQC experience enhanced regulatory compliance, smooth audits, reduced waste and downtime, and faster time-to-market without sacrificing quality.

Pharma companies can meet regulatory requirements by utilising predictive analytics, machine learning, and real-time monitoring while improving process efficiency, product quality, and patient safety. Now, it is possible to collect and interpret quality data with the Internet of Things (IoT) sensors, advanced data analytics, AI, and other tools. This transition from traditional, retrospective checks to proactive, data-driven insights allows for early issue detection, which lowers the risk of defects and improves overall product quality. This proactive approach is crucial for maintaining competitiveness in a highly regulated market where quality and compliance are paramount.

Streamlined regulatory submissions are an unbeatable advantage of electronic tools for drug product sponsors and regulatory authorities. The Electronic Common Technical Document (eCTD) is “the standard format for submitting applications, amendments, supplements, and reports” to the major regulatory health authorities like the FDA, European Medicines Agency (EMA), Health Canada, Therapeutic Goods Administration (TGA) in Australia, and Pharmaceuticals and Medical Devices Agency (PDMA) in Japan. This format organises submission content in a standardised structure, enabling smoother communication with regulatory agencies. By adhering to this standard, companies can simplify the review process and decision-making, leading to quicker approval and fewer delays. Advanced analytics, AI, and machine learning (ML) gather, integrate, and analyse large volumes of quality data from diverse sources, including process sensors, quality control tests, and customer feedback, to produce actionable insights and recommendations. Extedo and DocuBridge are widely used tools in the pharmaceutical sector for managing electronic regulatory submissions. These platforms assist in the preparation, validation, and submission of dossiers, such as electronic Common Technical Documents (eCTD), ensuring alignment with international regulatory standards.

Challenges in achieving digital quality compliance

Implementing digitally enabled quality compliance in the pharma industry comes with significant challenges. Modernising or replacing legacy systems is a massive task, demanding considerable investments of time, resources, expertise, and budget. It’s vital for pharma companies to thoroughly evaluate their current infrastructure, pinpoint gaps and limitations, and create a well-defined plan for modernisation. This effort typically includes migrating data from legacy systems to updated platforms, integrating various systems and databases, and establishing new data governance policies and procedures.

Beyond substantial resource requirements, digitalisation also requires meeting stringent regulatory requirements. With pharma companies relying more heavily on digital technologies for data management and exchange, they encounter increased cybersecurity risks and data privacy challenges. Cybercriminals may attempt to access sensitive information, such as intellectual property, patient records, and financial data, or disrupt operations through ransomware or denial-of-service attacks. The cost of a pharma data breach in 2023 averaged $4.82 million. The most common root causes for pharma data breaches include malicious attacks (45%), human error (28%), and IT failure (27%). Companies must have strong IT and cybersecurity teams to address information security issues.

Company culture and mindset influence an organisation’s success in adopting change. To fully benefit from digital transformation, it’s vital for pharma companies to embrace a strategic and risk-based approach, using best practices and industry standards. By doing so, they can effectively overcome these challenges and enhance their QMS through digital technology.

Embracing digitalisation is embracing quality

Implementing digitalisation is not simply about keeping pace with industry advancements; it is a strategic imperative that will shape the future of pharma quality compliance. Global compliance standards will constantly advance with new technologies, innovations, and pharma discoveries, pushing companies to adopt more comprehensive digital strategies. Continuous research and development are essential to stay ahead of industry challenges and maintain compliance in an increasingly digital world. Most importantly, this ongoing evolution shapes a future of safe, innovative, and improved pharmaceuticals that optimise the desired outcomes.

The opinions expressed in this article are those of the author. They do not purport to reflect the opinions or views of her employer.