"ValGenesis makes the end-to-end validation lifecycle process 100% digital, reducing validation cycle time by over 50% and thus, helping life science companies release their products to market more quickly."

What are the key problems ValGenesis is solving for customers?

Validation is a key lifecycle process for the life science industry before releasing systems for production, commencing with system assessment, authoring requirements and risk assessment, authoring test cases, creating trace matrices, executing test cases, implementing change management, performing periodic reviews, and ending with the retirement process. In life science companies, validation is predominantly a paper-based, manual process compared to other processes that are automated and digitized, whether they be laboratory information management, quality management, or enterprise resource planning. Validation is complicated, messy and error-prone when managed manually as a paper-based process, leaving islands of data in different formats, and resulting in huge compliance risks.

ValGenesis manages each of the validation lifecycle stages as a module and connects the dots that flow data from system assessment and author requirements right up to the retirement stage. ValGenesis makes the end-to-end validation lifecycle process 100% digital, reducing validation cycle time by over 50% and thus, helping life science companies release their products to market more quickly. Are there Case Studies of how clients have integrated ValGenesis software into their workflow?

A U.S. site for global biotechnology manufacturing and product supply operations had its validation documents and change control requests associated with several key products being approved by stakeholders across company sites in the US and Europe. The department was facing many challenges commonly associated with paper-based validation. The work eventually got done, but with more manual effort, duplication, and time than necessary, given the technologies available.

The company sought a digital validation solution that could deliver similar ROI improvements that it had come to expect from other enterprise systems such as ERP, DMS, LIMS, and MES. It needed a forward-looking approach that would eventually lead to 100% electronic validation lifecycle management.

ValGenesis was configured to meet more than 95% of the company’s requirements out-of-the-box and was implemented, validated, and put into production in 12 weeks. ValGenesis offered the ability to migrate from paper toward 100% electronic validation. The project-level implementation was deemed a success based on efficiency improvements, eliminating non-value-added activities, and enabling consistency.

One year later, the department implemented an additional ValGenesis module to manage change control as a closed-loop process with validation. Through this upgrade, users could create their process flows and descriptions to capture the required justification for changes made within a validated system. Within the next twelve months, the ValGenesis solution was extended to a global biologics’ development division for validation documents required in a state-of-the-art manufacturing process for new products and a supply center in Europe.

ValGenesis today streamlines the validation process for more than 3,000 users across five global company sites. Real-time access to validation documents and data enables various stakeholders to achieve compliance collaboratively and efficiently.

What are your observations in terms of the pace of cloud adoption amongst life science companies?

Life science companies have always been more conservative when it comes to the adoption of cloud technologies. These companies with fears about data privacy, data and IP protection were in the habit of purchasing a commercially available software system, installing it in their internal servers, and managing it in compliance with a corporate IT strategy and a set of standard operating procedures. Aside from the development of the software package, everything else is owned, managed, and maintained by the internal IT staff of the company. This results in high overhead costs to the company. The expense and capital burden of the on-premise model in many companies takes a back seat to the inherently slow pace of deploying functionality to the business.

The cloud business model changes the game significantly. True multi-tenant cloud computing-based systems can deliver significant value by sharing infrastructure and software across several customers. Pre-pandemic, some leading life science companies had started their digital transformation pursuing cloud-enabled capabilities with clinical trials and data science. But the current pandemic has now created an inflection point in digital adoption and technology-led business transformation.

What role has ValGenesis played for clients working remotely during the pandemic?

Technology has advanced to provide new platforms to manage manufacturing and validation processes remotely. With the help of the ValGenesis platform, our clients can now manage the validation process remotely or with limited onsite resources, without any disruption to their supply chain.