The Challenge
As a service provider, SSI Strategy had seen many emerging biotech companies struggle to get their Quality programs up and running. Clients often didn't know where to start, from the processes themselves to the software they would use to scale those processes. As the experts in the room, SSI was often asked what QMS they would recommend. But with tight budgets and limited resources to manage systems, traditional enterprise solutions such as MasterControl were not realistic. And the affordable "DIY" options like SharePoint and Egnyte didn't meet the necessary compliance standards, nor did they offer enough customization.
SSI was hoping to find more than a software. They hoped to find a partner that understood the need for a flexible, affordable solution that customers would find easy to use, and would get their clients fully compliant within weeks.
The Solution
Having connected initially through mutual customers, SSI and Kivo sat down to discuss a partnership. To begin, SSI outlined their needs, which included:
- A standard initial setup that matched SSI's methodology, to be the starting point for each customer
- Flexible configuration that would allow them to tailor processes, activity management, document templates, and metadata for each client
- Flexible pricing based on client size, allowing them to offer a cost-effective solution for even the earliest-stage biotech teams.
- A full QMS feature set, including Part-11 compliant e-Signatures, activity management, vendor management, training, and reporting
"We evaluated multiple QMS systems to see what would best suit us and our clients. Kivo's flexibility was truly unparalleled. No one else could offer the ease of an out-of-the-box configuration with the robust customization options - and definitely not for such an affordable price."
To begin, Kivo customized the standard setup to match SSI's workflows. During the trial period, SSI put Kivo through its paces. The intuitive interface combined with Kivo's flexibility, price point, and feature set sealed the deal.
The Results
Once the contract was signed, Kivo's first instance was up and running in just 3 weeks. For SSI's customers, Kivo now enables them to go from whatever their current state may be to a fully compliant quality foundation in less than 2 months.
“Many of our clients are interested in a system that is easy to use, quick to implement, and is cost-efficient, making Kivo a great fit.”
This "time to compliance" is essential for SSI's clients. SSI's strategic expertise coupled with Kivo's QMS gives emerging biotechs the total Quality package, allowing them to meet rapidly approaching deadlines with confidence.
