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Announcing Kivo for Quality: A QMS for Pharma and Med Device Teams

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As discussed in our previous post, Kivo GO represents a huge step forward for collaboration across Regulatory, Clinical, and Quality functions. Obviously, this wouldn’t be possible without the launch of Kivo’s QMS, a validated and fully compliant quality management system. In this post, we’ll outline some of the features and use cases designed specifically for Quality teams. 

Universal to all our use cases are controlled documents. Kivo’s QMS is CFR Part 11 compliant and automatically generates an audit trail for all document changes. As you create new documents, you can leverage templates to speed up your processes.

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Accelerating CAPA and Audit Management

We briefly discussed the project management capabilities of Kivo GO in our last post too, but let’s dive deeper into quality-specific projects, such as CAPAs, Deviations, and Audits

Once your initial SOPs surrounding quality processes are drafted, these projects should – by definition - follow a repeatable process. Despite this, setting up a new CAPA or audit can often be a manual effort, duplicating individual documents, building a tracking spreadsheet, etc. With Kivo QMS, you can say goodbye to many of those manual processes and significantly speed up project creation and management, while improving adherence to the original SOPs. 

First, you’ll want to set up your project templates. We have out-of-the-box templates for CAPAs, Deviations, and Audits, but these are fully customizable to perfectly match your SOPs. These project templates include all the necessary milestones, tasks, and sub-tasks, so you can create a full plan with the click of a button. And they can be aligned based on how you define quality processes. For example, some customers define deviations as a part of a CAPA process. Some define deviations as a peer process to CAPAs. Kivo can be configured to support any approach or even roll out activities like CAPAs and audits over time.

To create an Audit or CAPA in Kivo, simply create a new project associated with the related vendor. For an Audit, this project plan might include Initiation, Audit, and Closeout milestones. Your tasks will automatically populate under each milestone based on Kivo’s configurable project templates, where you can assign them to the appropriate parties, mark status, and build out your project timeline. 

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However, as with most projects in life sciences, there are a number of potential outcomes for these projects. To accommodate this, we’ve added “Events.” Examples of “events” for an Audit include Major Findings, Minor Findings, Critical Findings, or Recommendations. For a CAPA, this might include Corrective Action vs Preventative Action. 

Adding any one of these Events to the project will add the necessary tasks into your timeline, so you can follow the appropriate path. Of course, you can also view progress of any project in list or Kanban format, as well as run or automate reporting directly to your inbox. 

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This makes it simple to standardize these repetitive projects, improve visibility, and keep things on track. 

Managing Vendors 

Vendor management is simple with Kivo. Any type of vendor can be managed within Kivo QMS, from manufacturers to suppliers to consultants. The types of vendors can be customized to encompass any vendor category you might need. When adding a new vendor into the system, you can add essential information such as status, primary contact information, GDPR policy, certifications, certification expiration dates, and audit dates.

Once your vendor is added, simply file  your vendor in the appropriate Cabinet. Doing so will build out placeholders for all necessary documentation within the QMS, such as vendor qualification documents, questionnaires, agreements & contracts, and training records. These documents can be accessed from the vendor record or from the QMS.  

When it’s time for an audit, or in the event of a CAPA, you can associate your vendor with the appropriate project type. Simply select your project type, template, add a project name and start date, and Kivo will automatically build out the project template per your SOP. 

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Training Capabilities

With Kivo QMS, you can train on any approved document or video. Assign trainees by department or by individuals. Individuals who are assigned a training will see their assignments on their home screen as well as receive email notifications. After reviewing the training, individuals mark their training as complete. 

Within the reporting module, you can view training completion by content, department, or individual user. If you choose, you can go one step further and automatically receive alerts when trainings haven’t been completed, or when an individual has a certain number of trainings outstanding, or any other reporting use case you can think of! 

Documents can also be set with effective dates and expirations dates within the metadata. This allows you to easily build reports showing which SOPs may be expiring soon. To automate your workflow further, you can send automatic alerts to your email when an SOP is within the expiration window (for example, 60 days prior to expiration). 

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In summary

Developing a QMS was an essential component of Kivo GO. Without it, we wouldn’t be able to address the needs of our customers across all key departments and teams. The ability for users across functions (Regulatory, Clinical, etc) to access SOPs and complete trainings within the same system they use for their day-to-day improves communication and speeds up internal work, and the ability to manage vendors helps the emerging sponsors we support keep track of their operations while keeping resources in check. 

If you could benefit from a compliant, validated QMS, request a demo, or try it free for 30 days - we’re confident you’ll like it! 

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