The regulatory industry is full of one-off solutions and integrations, leading to siloed systems. The Generis CARA Life Sciences Platform is an enterprise workspace that offers seamless collaboration for regulated processes. In this blog, we look at whether CARA can be the all-in-one solution you need.
Over the years, life science companies have implemented various content management solutions to manage specific aspects of their business (e.g., clinical, safety, quality, regulatory, manufacturing, sales, operations). Unfortunately, these systems are often siloed and managed independently of each other.
However, new and future regulations, such as SPOR, are data-driven, relying on data typically dispersed and maintained in various siloed systems throughout the organization.
Additionally, internal processes and procedures have long struggled to maintain control when content needs to be shared between two or more systems, as is the case when building a regulatory submission or performing a “change control.” As a result, these processes are often disjointed and require manual steps, which are often time-consuming and prone to error, risking the quality of the entire process.
We need tools that collaborate, share standard vocabularies, and can be holistically viewed and managed.
In the past, companies have tried to solve these problems with customized integrations. The CARA Life Sciences Platform from Generis offers an alternative.
Generis CARA Functionalities & Offerings
Below are some key CARA functionalities and offerings you will want to consider:
- CARA is content store agnostic, allowing customers to integrate multiple point solutions (such as Box, Documentum, SharePoint, and Alfresco) into a single platform.
- Users can benefit from a shared data lake for harmonization, reporting and maintenance. CARA supports regulatory, quality, safety, clinical and other enterprise solutions.
- Even systems not directly under the CARA platform can benefit by using the data lake as the master data set.
- In the next release, CARA’s data model will support xEVMPD and IDMP.
- The data lake supports robust reporting and filtering as well as analytics.
- Views to live feeds from external data sources can be configured, such as the FDA drugs database and related documents within your repository.
- “One User, One License.” CARA’s per-user cost does not go up as you bring additional solutions into your platform.
- Regulatory users can benefit from CARA’s built-in email functionality, pulling individual questions from an agency’s communication and providing potential responses.
- Auto-translations can be added to translate content to multiple languages quickly.
- Customers can choose either multi-tenant or VIP service hosted environments based on their specific business needs. VIP services are on a dedicated server and allow the customer more flexibility with upgrade schedules.
Implementing Generis CARA: What You Need to Know
As part of your evaluation and implementation discussions, you will want to pay close attention to those areas that may impact the adoption and rollout:
- Moving to a single platform and data lake does not happen overnight. To be successful, you will need to develop a complete list of existing systems and a roadmap to get you to your final state. If you have not done this before, consider using a third-party vendor.
- Harmonization into a single data lake will require careful planning and oversight. Develop system governance to oversee data and clearly document ownership, triggers and dependencies. Keep in mind regulatory reporting requirements for the data.
- Some existing systems may not be supported by CARA yet. You may need to consider alternatives and the potential need to migrate the content. Consider using a third-party and/or migration tool to assist with this activity.
Life science companies need to invest in solutions that promote collaboration and share content and data to stay competitive and compliant. The Generis CARA Life Sciences Platform has a unique way of leveraging existing solutions while providing an improved user experience and harmonized data governance, which you should consider during your evaluation.
Daelight Solutions is a Generis Certified Partner with the necessary tools and knowledge to migrate your content and data to Generis CARA. Contact us to see how we can help you figure out whether CARA is right for your organization.