5 Tips to Gain Executive Support for a Digital Validation Strategy

Validation is the foundation of current Good Manufacturing Practice (cGMP) in the life sciences industry. As such, it is critical to gain the understanding and support of the Quality Assurance (QA) leadership when seeking to develop a new digital validation management strategy.

Today, many highly regulated industries, including the life sciences industry, are undergoing significant changes. More and more companies, both big and small, are beginning to leverage digital technologies to transform validation models from manual paper-based and hybrid approaches to automated digital validation solutions that streamline processes and can scale to support growth and aid competitiveness by reducing cycle times and increasing speed-to-market.

In this article, we highlight some key recommendations for life sciences validation and quality assurance managers to gain executive understanding and support when seeking to develop and implement a holistic digital validation management strategy and solution.

Read this blog to learn more about our five tips:

     1.   Involve cross-functional stakeholders to get the ‘big picture’
     2.   Quantify the gains of implementing an e-Validation solution
     3.   Highlight the added value to the organization as a whole
     4.   Showcase the benefits to validation and QA teams
     5.   List the benefits of having an enhanced view of validation data and how it can be put to additional use

1. Involve cross-functional stakeholders to get the ‘big picture’

When identifying opportunities and substantiating the benefits of a new digital validation strategy, other relevant business stakeholders from outside the validation and Q&A functions should be consulted. Like any other business investment, input from varied business stakeholders helps to provide a complete picture of the benefits, costs, risks, and time-to-value expectations of a digital validation management solution.

Consider involving members of your finance, operations, legal, and IT teams. Here are five questions about the risks of not proceeding with a validation lifecycle management approach that could be asked as part of the discussion:  

• Are we comfortable not making an organized effort to leverage technology and validation data to increase the value and quality we deliver to the organization and our customers?
• If we don’t undertake digital transformation in our validation processes, could we potentially fall behind competitors who do?
• Are we comfortable continuing to have multiple, duplicate validation data sources that can create inconsistent reporting?
• What is our tolerance level for the regulatory and system risk that comes with postponing a holistic validation strategy?
• What is our tolerance for the inefficiencies that result from validation data that is not reliable or readily available to internal and external stakeholders?

Approaching the discussion on enhancing an organization’s validation management processes by investing in a new digital solution—by including colleagues who are not directly involved in validation and QA functions—can assist you in making the case for funding and resourcing this transformative initiative.

2. Quantify the gains of implementing a digital Validation solution

It is important to quantify the effort of building additional validation management capabilities as well as the anticipated business enhancement gains to present to your senior executive team decision-makers.

Consider including realistic estimates of the number and scope of validation processes affected and the enhancement of their capabilities. You should also include implementation and on-going costs as well as additional revenue attributable to improved validation processes, decision-making, cycle times, production, and speed-to-market, in your analysis. 

Our team of experienced Process Engineers can help you to quantify the benefits of implementing our digital validation software solution, Kneat Gx, for your business. If you would like to learn more, please contact us to book a personal meeting with one of our experts.

3. Highlight the added value of e-Validation to your organization

Consider how the entire organization will benefit from a unified and harmonized approach to validation processes. Demonstrate how paper-based or ‘hybrid’ validation approaches can lead to process discord, whereby efficiency and cost can be negatively impacted:

• Efficiency—an organization must arrange access to and review records and data that are not standardized and that could be stored in different locations. This can significantly slow down the validation process and delay release to production, leading to lost revenue for the business.
• Cost—paper and printing, shipping, long-term storage, destruction, and disposal spend can have a significant impact on an organization’s bottom line.

Positive effects of digitizing the entire validation lifecycle include the enablement of life sciences companies to develop and deliver therapies as efficiently as possible, reducing cycle times, changeover, and time-to-market, whilst enhancing quality and patient safety. 

4. The benefits of e-Validation to validation and QA teams

For Validation Managers and QA Managers, using a digital solution that can scale to meet all validation needs across all facilities internationally, has many benefits. It unifies and unites global teams online, and helps to deliver better data governance, data integrity, and decisions about risk.

Data governance

The ability to store and get instant access to your validation data, set up restrictions over who controls it, ascertain whether it is reliable and maintained—and have full control over how long it is stored and how it is disposed of—on one secure platform—gives managers complete control over data governance.

Data integrity

Data integrity is “properly recorded information”. However, regulatory bodies follow a more detailed definition—a set of standards known as ALCOA. This acronym stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

Kneat enforces data integrity best practice to ensure full compliance with both FDA and EMA regulators. Kneat ensures users apply FDA 21 CFR Part 11.10(a) (1) compliant signatures, providing robust attribution in tandem with a secure role-based user access control system, ensuring only the right users have access to the right documents. Kneat also supports EudraLex Annex 11, Section 4. (2)

In 2020 alone, the FDA released over 150 warning letters for data integrity infringements—a 60% increase since 2016. The combination of using a consistent method to validation and getting instant access to validation data analytics helps validation teams to mitigate this kind of compliance risk.

5. The benefits of having an enhanced view of validation data

Capturing all validation data direct to a secure database, with all entries and changes recorded into an exhaustively comprehensive, time-stamped audit trail, gives users an unprecedented capability to create, manage, access, and mine validation data.

Kneat automatically generates an independent detailed, un-editable audit trail in real time. Managers can see any user action, correction, or change with a corresponding timestamp, and a range of other particulars—at the click of a mouse. And during audit, any audit trail can be filtered and re-ordered to pinpoint any desired information.

How to put validation data to additional use

Instant access to status reports  can give validation teams the opportunity to add additional value to an organization. Validation data can also be analyzed to improve business decisions and performance, uncover new insights, and develop new products and services faster.

Within the reports area of Kneat, you can run status reports for all projects, systems, and validation deliverables. Our users can run an overall report, create a report using filters, save a filtered report, export the report to PDF, and share it with other departments.

Final thoughts

High performing life sciences organizations are committed to extracting maximum value from their validation data and processes. Deploying digital validation empowers all stakeholders—validation and QA managers get full transparency over all validation processes, auditors get instant access to the data that matters, the organization saves time and money—resulting in an increase in competitiveness and faster time-to-market—and executive teams can make better, more informed business decisions.

Book a demonstration today to discover how Kneat can help your business to maximize validation efficiency.

References

1. CFR – Code of Federal Regulations Title 21, [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=11.10].
2. EudraLex Annex 11, [https://ec.europa.eu/health/system/files/2016-11/annex11_01-2011_en_0.pdf].