Cockpit is designed with the end goal of identifying the needs of the customer and business, and working those needs into the product developed.
The Cockpit Platform is a validatable environment for product development. Synergio offers the Cockpit Validation Kit, which enables companies to confirm the validation of the Cockpit Platform against GAMP 5 and AAMI TIR36-2007. You can either validate on your own or use Synergio’s Validation Services to ease the burden.
SaaS Solution Available
Synergio’s ’SaaS solution offers multiple options depending on your needs. Access can be limited to read-only, which is perfect for those who wish to view the data, but not manipulate it. Synergio also offers Named and Team Access options for those who need to work directly in the environment.
Rich Text Editor
The Cockpit Platform provides a rich text editor for many areas and fields. Users can format text, insert images, link to other applications, as well as create complex tables using an inline or pop-out interface that is automatically saved to the database.
Cockpit’s allocation matrices provide an easy way for teams to allocate requirements—whether they be design inputs, design outputs, user needs, etc.—to Bill of Material groups. Matrices are also available for quick connections between various levels of requirements.
Cockpit supports library creation, and configurable libraries can be reused throughout multiple projects. Categories of libraries include: Regulatory Requirements, Hazards, Harms, and Requirement Reuse.
The Team Review feature in Cockpit allows teams to review documents real-time. This new feature allows for markups, comments, and deletion suggestions within a document or section. Both formal and informal reviews are provided and can be configured based on the team’s needs.
The Cockpit Platform supports seamless reuse of all types of data including requirements, hazards, risks, and design components. Cockpit allows the user to create libraries of regulatory and business requirements, harms libraries with predefined severity, and design modules or components that can be used in multiple system configurations. Teams can reuse items “as is” or reuse the items with variations. Cockpit will track and report any variations on reused items. It also supports product line engineering and allows users to reuse requirements while modifying the details of the requirements based on the configuration information where the requirement is being used. The platform allows design engineers to create derivative design projects that are initially a copy of a previous design. Cockpit then tracks all variations from the original design in the derivative design. All of these reuse capabilities allow design engineers to create new robust products quickly by reusing the knowledge obtained from previous designs. This allows Cockpit users to get their products to market sooner while still retaining a high level of quality.
Cockpit provides an easy-to-navigate organizational hierarchy to manage all organizations, product lines, and projects within your environment. The file browser-like Table of Contents makes it easy to navigate.
Users, User Groups, Roles, and Permissions
Cockpit allows organizations to create multiple users and user groups. All users and groups are subject to Cockpit’s extensive privileging model, which allows administrators to set read, write, and view privileges for all aspects of Cockpit. This is done through the use of Roles. Administrators can create role-based workflows that can be re-used throughout all projects. Sample roles include: Quality Manager, Independent Reviewer, Lead Reviewer, Regulatory, Manufacturing Engineer, Lead Design Engineer, Project Manager, Project Approver, Approver, Reviewer, and Assigned To.
Cockpit supports full LDAP functionality for customer-hosted environments, allowing login from multiple servers on a single Cockpit domain. LDAP is not available for SaaS Cockpit.
Part 11 Compliance
Cockpit supports 21 CFR Part 11 Subsection C relating to strong passwords and password expirations. Cockpit also allows for full configuration of login attempts and lockout settings.
Configurable Management Features
Cockpit allows for company-specific object types for all items within the platform (e.g., requirements, risks, tests, etc.). Other configuration options include risk scoring, requirement scoring, and test result management.
Already have a Word or Excel document with your requirements? The Cockpit Platform provides out-of-box capabilities to import data directly from Word, Excel (including CSV), and XML files.
Lifecycles and Workflow
Cockpit provides a comprehensive, configurable workflow capability allowing companies to tailor the platform to their current in-house process. Teams can define workflows, life cycles, and roles at the item level (risks, requirements, etc.), document level, and project level.
Cockpit includes full version control. Define project baselines and show differences between versions. More granular item-level versioning is available, allowing users to see changes to individual items over versions.
The Cockpit Platform has extensive side-by-side differencing for documents as well as differences for all items (requirements, risk, tests, documents, projects, etc.). Difference reports are available on all objects that have version history.
Full audit trails are included with all objects in Cockpit, from individual items like requirements or risks, documents, document sections, etc. All changes are tracked, providing evidence in the case of a regulatory audit.
Orphan Requirements Report
The Cockpit Platform generates reports to easily identify orphan requirements during any phase of product development. This report shows those requirements with missing links, guiding teams to allocate parents.
The Cockpit Platform provides a number of tools to perform Impact Analysis on an object. The built-in Dashboard and graphical trace capabilities let users see what other objects will be impacted by the change, allowing for faster team response.
The Cockpit Platform provides an out-of-the-box dashboard for an overview of an object and its connections. Each object dashboard contains different information, including parent and child objects as well as any attachments or action items associated with it.
House of Quality Reporting
The Cockpit Platform provides House of Quality/QFD reports to ensure the customer-desired product is the one being designed. These reports can be exported to PDF for a more formal review outside of the platform, if desired.
END USER FEATURES
The Cockpit Platform provides multiple export options to distribute data captured. Documents and reports can be exported to PDF, Word, Excel, Powerpoint, and XML.
Cockpit’s unique multi-views allow teams to define multiple views for the same set of data. Teams can complete multiple exercises within the same window, eliminating time spent navigating around the project to accomplish the same task. For example, an Engineering Requirements document may have a view to allocate tests to engineering requirements.
In-Platform Notifications and Emails
The Cockpit Platform provides many external and internal ways to notify users. Configurable workflows allow teams to send notifications based on event triggers. These notifications can be messages in Cockpit, emails to user(s), or both. Outside of workflow, Cockpit also provides the ability to email items directly to others. The recipient is given a link that brings them directly to the object, document, or project in question.