Digital transformation has taken the world by storm. An increasing number of companies are adopting cloud-first strategies with pandemic-driven remote work accelerating this transition. However, this step toward modernization comes with some challenges for regulated companies.
The myriad of labeling guidelines, along with the requirements and regulations that life sciences companies face can be overwhelming. What’s more, they’re constantly changing as various countries and geographic regions enforce their own versions of labeling standards. And with the costly consequences of non-compliance and your reputation on the line, it is a topic that life sciences companies take quite seriously.
On the upside, compliance provides an opportunity for process improvement. Sure, a legacy process tied to a legacy system works just fine, but consider error-prone manual approval processes, the cost associated with IT being involved in labeling and the opportunity for productivity gains and competitive advantage that helps grow the business. When you examine the labeling process as part of a compliance effort, you start to realize there is much to be gained from taking a broader approach.
Recognizing that life sciences companies have unique needs when it comes to labeling compliance, we built Label Cloud Compliance. It’s the world’s first validation-ready, multi-tenant cloud labeling solution. With Label Cloud Compliance, regulated companies have access to a full label management solution that eases compliance and validation efforts while also delivering the benefits of a Cloud solution.
Let’s take a closer look at the capabilities of Label Cloud Compliance.
- Label Cloud Compliance is a full-scale multi-tenant cloud solution which means that a new customer can be onboarded in minutes without the need for professional services, translating to a lower total cost of ownership. Compare that to an on-premise or other Cloud solutions where you may have to wait weeks for professional services.
- Label Cloud Compliance digitizes the entire quality approval process. It enables you to comply with the major regulations that impact the life sciences industry. It includes role-based access, document versioning, configurable approval workflows, electronic records and electronic signatures (ERES) and also gives you12 years of print history which enables you to visually track every label you print during that time.
- You can easily scale Label Cloud Compliance across your business. Suppliers and partners can easily access compliant labeling from any internet connected device.
- Label Cloud Compliance features a three-tier environment that includes DEV, QA, and PROD instances that allow you to follow best practice approaches for labeling development, testing and deployment.
- Label Cloud Compliance is validation-ready. This means that it comes with a Validation Acceleration Pack or VAP for short. This is a collection of documents that simplifies the process for life sciences companies to expedite labeling system validation. This set of documents contains requirements documents, design documents, test plans, and reports to help customers speed up their testing/validation processes. Our professional services group can provide additional services for customers that may need assistance with validation.
Compliant systems need to be revalidated anytime a change is introduced. With the DEV, QA and PROD environments, companies can mitigate risk by testing changes in the DEV environment and validating potential changes in the QA environment. This allows them to only publish tested and validated labeling assets to the production environment. With three tiers, customers can safely test new features or versions while minimizing the need to revalidate.
To further reduce the frequency of validation, Label Cloud Compliance also comes with a relaxed software release cycle. Standard, multi-tenant cloud platforms can sometimes be updated two or three times each year. However, Label Cloud Compliance is only upgraded once per year to reduce the validation burden for regulated companies. We also give those customers a three-month testing period before the production environment is updated. This allows our customers to benefit from a managed labeling solution while minimizing the validation burden.
Undertaking a compliance effort can be daunting, but with the right processes and tools in place, companies can save valuable time and money. We explored how Label Cloud Compliance provides regulated companies with compliant cloud labeling in one of our recent webinars. You can watch the on-demand version here.
To find out more about how Label Cloud Compliance can address challenges in the life sciences space, make sure you check out Loftware’s upcoming webinar with Epson and 3M on July 15. Click here to register.