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With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.
Unreliable data leads to unreliable validation execution. Quality teams, however, are still managing validation projects using paper-based processes that drive information silos, poor tracking, and fragmented data. This leads to higher operational costs and increased risk of non-compliance, which can significantly impact the bottom line: poor data quality is responsible for an average of $15 million in losses every year, according to Gartner (1).
COVID-19 disruptions across life sciences made executing on paper harder because of limited access to on-site files. The industry persevered by adopting digital solutions that enable remote ways of working, proving that this approach could be effective. Despite the progress made, more work remains to increase efficiencies and speed time to market. The path to rock-solid, zero guesswork validation starts with regulatory support and alignment, best practices and guides, and modern tools.
A rise in violations involving data integrity during inspections and audits led the FDA to publish guidance that helps companies remain compliant with current good manufacturing practices (CGMPs). The agency advises that data integrity needs to be prioritized throughout the CGMP data lifecycle across the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data (2).
FDA also explained that system designs and controls should allow for detecting errors, omissions, and unusual results–outcomes that cannot be easily identified with paper-based processes. Because the guidance requirements for record retention and review don’t differ between paper or electronic, this update supports the shift to a digital model.
Using paper to check and mark things off is a normal practice in life sciences, even if it is not a very good process for error detection, data collection, or metrics, says Bryony Borneo, quality assurance director at global contract research organization (CRO) Emmes. Transitioning people who are used to using paper to something electronic can be a big challenge since many aren’t as open to adapting to a digital world, she adds (3).
By moving from paper to a modern validation system, companies can create and organize validation activities, manage a global library of test scripts, and electronically execute protocols and record validation data while remaining compliant with regulations such as US Code of Federal Regulations Title 21, Part 11. Quality teams can also link projects and artifacts and easily report on key metrics detailing validation outcomes. The improvements streamline validation projects and deliver accurate and reliable data.
Stephanie Mungle, director, quality compliance at Supernus Pharmaceuticals, says that COVID-19, and its accompanying challenges, proved that using a paper-based system limits productivity while working remotely. There has been an acceleration in the adoption of digital solutions and companies are seeing positive benefits (3).
Over the past two years, the developments across quality management showcased what is possible through the swift introduction of tools for remote and digital execution. These new ways of working helped teams to conduct faster and more efficient validation projects while establishing stronger data collection practices.
Quality teams are collaborating on validation deliverables virtually and in real-time, enabling visibility into critical activities and project statuses. This can help establish consistent validation processes over the long term, improving overall audit and inspection readiness. Building a solid data foundation and gaining more experience with remote ways of working are driving positive change and making it easier for quality teams to remain compliant with regulations.
Industry standards can advance digital transformation in quality by applying best practices internally and with third parties. According to Sanjeev Kumar, senior director, data integrity and technology at Vertex Pharmaceuticals, there is greater awareness of data standardization to identify developing trends and insights from information. But one of the big barriers to standardization is data attribution and the inconsistencies in how companies manages this process.
Alignment across external partners is critical because without established standards, each stakeholder will rely on their own methods to collect, store, and review data. Adopting well-established industry standards can help maintain data integrity across the supply chain.
Motivating partners, like contract manufacturers, to adopt a standardized set of parameters can streamline how companies work together, adds Kumar (3). Standardizing how content is managed and organized improves collaboration with partners, suppliers, and other key stakeholders. With an established document and artifact hierarchy, taxonomy, and metadata, users can quickly and easily search, navigate, and locate necessary content.
If broader known industry standards aren’t an option for use, modern systems can provide a vehicle for standardization. A solution with embedded best practices can remove friction and prevent quality leaders from reinventing the wheel. The shift to digital solutions is driving standardization of data, explains Mungle, who expects this trend will continue in quality and manufacturing (3).
Validation management, in many ways, is a company’s last line of defense against compliance issues, but the overreliance on manual processes can slow down projects and increase costs. Prioritize data integrity, enable digital and remote work, and drive standardization to establish the necessary foundation for paperless validation execution. This will shift the industry from the traditional document-centric approach toward a greater focus on data. Below are suggestions for companies that are ready to start their validation management transformation:
Secure alignment. Add cross-functional stakeholders into the scoping process early to ensure that all needs are met across teams. Establish a meeting or reporting cadence to maintain engagement through project kickoff and configuration.
Identify areas of improvement. Map out the validation process to quickly identify what needs to be optimized. Make sure to include computer systems or facilities, utilities, and equipment. In doing so, this exercise will help to create user requirements.
Establish a governance team. Form a global team to oversee the management of templated validation content. Governance is paramount to harmonize processes, especially for multi-site companies. Begin this practice before implementing a digital validation system.
Leverage the power of technology. Evaluate technologies that meet organizational requirements while promoting industry best practices. A flexible cloud-based solution that can quickly scale with a company’s growth and adapt to evolving market conditions will keep the organization up to date. Make sure it accepts multi-user experiences throughout the validation lifecycle to help accommodate both on-site and off-site support.
Keep things simple for partners. Consider solutions with intuitive user interfaces and dashboards to surface metrics. This can prevent issues with user adoption over the long term.
Set up consumer-led process exercises. Workshop how validation processes will be managed in a new solution before executing user acceptance testing to ensure that the configured application will meet current and future business requirements.
Plan for ongoing, comprehensive change management. Ensure robust training and continuous support for all stakeholders throughout the process. Paper is commonly used during validation because users have a higher comfort level. Provide sufficient training materials, collect feedback, and keep an open line of communication to address issues or concerns. Working with vendors that offer full support and resources will provide a boost to change management efforts.
Enable end-to-end quality management. Take validation modernization a step further by bringing together quality assurance, validation management, content control, and training on a single, unified platform to drive greater efficiencies across the supply chain. This can significantly streamline quality processes, from change control through paperless execution and final reports all in one solution.
It is essential to embark on this journey with an open mind. Take an iterative approach for focus and precision because it can quickly become overwhelming if you pile on the transformation projects. Adopting a phased approach as an entry point can help establish a strong core and a successful model.
The industry is at an inflection point where more companies are shifting from legacy systems and processes to modern digital solutions for paperless execution. From enterprise-wide transformations to biotechs getting started on scalable and agile systems, the transition toward more connected quality management is well underway.
Validation management is an area in need of modernization, and new technologies and innovative approaches that enable faster paperless validation projects are on the horizon. Companies will gain greater visibility and productivity by aligning teams, mapping processes, finding the right quality solutions, and driving change management. This will finally help validation teams feel confident that their validation management is proving accuracy, as is intended.
1. S. Moore, “How to Create a Business Case for Data Quality Improvement,” Gartner.com, June 18, 2018.
2. FDA, Guidance for Industry, Data Integrity and Compliance with Drug CGMP, (CDER, CBER, and CVM, December 2018).
3. Pharmaceutical Executive, “Keeping Tabs on Quality: The Rise of Digital,” PharmExec.com, January 11, 2022.
Volume 46, Number 2
When referring to this article, please cite it as M. Jovanis and N. Ricciardelli, “Driving Consistency in Validation Management,” Pharmaceutical Technology 46 (2) (2022).