A Closer Look at Paperless Validation’s Impact on Biotech

The true time and cost benefits of a digital validation solution were demonstrated in a recent study:1

• A 50% increase in validation efficiency
• A 10% decrease in project duration

That 10% gain not only means that less time is spent in development and manufacturing, potentially saving millions of dollars, but it could also be the deciding factor in whether a particular biological product is the first to market. As we will see in a case study example, early implementation of digital validation delivers biotech companies their most impactful results.

Paper-Based Validation in Biotech: No Longer a Choice

The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. The continued use of paper validation in a Pharma 4.0 world has cost biotech companies untold fortunes due to the time and effort wasted on its inherent inefficiencies. Longer timelines, more human errors, and burdensome compliance efforts are all consequences of this outdated process.

Digitizing and automating processes is paramount to avoiding manufacturing and regulatory delays that jeopardize patient health.

Delivering Game-Changing Business Protection and Acceleration

The benefits that biotech companies gain from digitizing validation are extensive. Here are three examples:

Data security and integrity — The right validation software ensures compliance with ALCOA+ principles through server-generated time stamps and other forms of document security.2 This mitigates the risks of error and manipulation exposed by paper-based validation and minimizes the opportunity for compliance violations. Further, adherence to ALCOA+ ensures data is not just secured, but available in its entirety to authorized personnel via a permanent archive.

Manual processes create the opportunity for significant risk via intentional data manipulation. Breaches and improprieties have intensified scrutiny from regulatory authorities, and the chance for inconsistencies to result in failures and warnings is very real. Data integrity, and adherence to ALCOA+ specifically, should be viewed as a leading benefit of digitizing validation.

Speed to market — Any advantage that accelerates market access is vital. This is one of the most critical success factors for biotech companies and their products. Validating absolutely everything is highly inefficient and does not take advantage of the critical thinking-based benefits of computer software assurance (CSA). Software that assures the correct amount of validation with input-based decision trees reduces the burden of validation, freeing people to focus on tasks that truly require human attention.

Paperless validation systems standardize workflows and consistently enforce standard operating procedures, reducing training/retraining time. Documents and objects can be automatically routed to the next user, and the review process can be optimized through standardized libraries of templates. Additionally, cloud-based systems with nonstop monitoring, maintenance schedules, and built-in fault tolerance (a) reduce system management overhead and (b) ensure rapid disaster recovery to minimize downtime. The total result is lean processes running the necessary amount of validation with minimal downtime between steps.

Compliance — Regulators want to see consistent, GDocP-compliant, template-based documentation. It is as simple as that. Standardization instills confidence that authoring and other processes have been conducted in accordance with FDA, EMA, and other guidelines.

With paperless validation, biotech companies are always ready for inspections/audits. Records are automatically updated, and everything an inspector/auditor might require is readily accessible — even remotely. Digital validation can reduce audit preparation time by up to 90%, drastically reducing downtime and the strain on everyone involved.

Impacting the People Who Make Biotech Tick

Digital validation’s value is clearly observable in the day-to-day activities of workers:

Engineers — Paperless validation gives them confidence in the real outputs of processes, affording them more time to focus on critical issues like process characterization. They also have a greater opportunity to assess where the most significant benefit can be gained from implementing other digitized processes.

Quality teams — Standardized documentation and SOP enforcement mean they can operate more efficiently and have greater confidence in their work.

Factory floor — More efficient processes mean leadership can redirect the efforts of SMEs and staff away from cumbersome manual validation activities and toward problem-solving tasks that only humans can do.

All biotech workers benefit from a digital validation solution that allows greater collaboration among distributed and remote teams. The ability to view relevant information remotely and simultaneously means workers can easily pull in colleagues as needed, massively accelerating time-critical decision-making processes.

Doing It Right from Day One: A Case Study

Some mature biotech companies hesitate to switch to paperless validation. There are common reasons for this:

• Fear the software solution will be complicated to use
• Complacency after adopting a document management system (DMS)

These reasons are common but logically unsound. Complexity, for example, does not come from the software tool; it comes from the processes that the tool helps manage. The software itself should be easy to implement, use, understand, and scale. It should make complex processes easier to digest, and there are few processes more complicated than those associated with biotech.

Complacency with a few mix-and-match solutions is likewise unreasonable. You might have a DMS and be able to author documents, control versions, route approval to the next system, and e-sign, but a lack of standardization across your documentation has consequences. Namely, it results in an inconsistent look and feel that is unappealing to auditors (and QC). Standardization, on the other hand, creates consistency from end to end, instilling regulatory confidence. For this, you need a solution purpose-built for validation.

A new company has at least one advantage over older, more established companies: It can implement digital validation from the start. A shining example is Theragent, a biotech company that custom designed a state-of-the-art facility leveraging digital validation, automated processes, and all the advantages a “smart” biotech factory provides.

A digital validation lifecycle management system was part of their plan from day one. Their experienced leadership knew the extensive validation requirements placed on a new CDMO would require a paperless validation system. They also had prior experience with digital validation in inspection circumstances and understood the benefits. Additionally, validating new equipment, processes, and methods with paper would have delayed opening and amplified the potential for costly manual errors. Hence, the decision was made to avoid the risks and bottlenecks of paper right from the beginning, with no loss of quality or compliance; it is baked in. As a digital-first company, they are functioning at an industry-leading level out of the gate.

Conclusion

Validation-dependent inefficiency is a thorn in the side of biotech companies that still rely on paper. For companies that embrace the ongoing transformation of Pharma 4.0 and the benefits of a digital validation system, however, the 10% reduction in project time is a massive competitive advantage. Biotechnology is a highly competitive industry, and potential clients want to see an efficient operation that leverages the most advanced, productive tools and methods. They want to know a biotech company can deliver rapid, high-quality results while staying on or under budget.

Not all digital validation solutions are designed equally; key differences exist in their features and vendors’ expertise. One important feature is the ease of integration with existing systems like QMS. Integration-ready technology with extensible architecture is critical for enterprise-wide digital transformation. It is also critical to choose a robust system that ensures compliance and maximally streamlines users’ efforts. This allows biotech companies to put their most valuable resource — the minds and efforts of their staff and SMEs — to the most productive and appropriate uses. In an industry with an ongoing talent shortage, there is no room at the top for companies that unwisely spend the efforts of their most capable and talented people.

Biotech leaders know they cannot afford the inefficiencies of manual, paper-based validation systems; the limitations have been well documented. Digital validation benefits every stakeholder involved, including those with the most at risk: patients. Greater efficiency means faster, safer, more effective products for the people who need them, and that is the fundamental purpose of this industry.

• 1Weeks, L. Digitizing Validation Yields 50% Overall Efficiency Gain According to ROI Study. ValGenesis. Published 2022 March 22.
• 2Jarvis, P., et al. How Can Digital Validation Solutions Enhance Data Integrity, and What Are the Challenges to Be Aware Of. Pharmaceutical Engineering. Published 2022 May 24.