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Aegis’ Professional Services organization is dedicated to providing you with the highest quality experience for your Discoverant and PRIMR implementations.
Our team of Project Managers, Application Specialists, Data Modelers, Testers and Validation Specialists are committed to ensuring a configuration of your system that fully satisfies your project scope. Aegis Professional Services also provides training for users, system administrators and implementers.
Through the use of the Passport project management methodology, the Aegis project team works with your team of process, quality and IS experts to develop a Discoverant / PRIMR implementation that allows you to meet your Manufacturing Process Excellence goals.
Passport is Aegis’s project management methodology for implementation of Discoverant.
- The Passport methodology is based on the Project Management Institute’s PMBOKâ Guide (Project Management Book of Knowledge), using best industry standards and practices
- We know you are busy - Passport ensures that your experts – process engineers, quality engineers, SMEs, data source owners – have input into the design and configuration of the Discoverant system and PRIMR forms, and that their participation is limited to those portions of the project that require their expertise
- Checkpoints are an integral component of the methodology to ensure that the Discoverant Hierarchies and PRIMR forms have been designed to your specifications
- Validation activities are an integral part of the methodology, providing an efficient approach to ensuring that the information you retrieve from Discoverant is in compliance with 21CFR Part 11 and can be used for cGMP decisions and regulatory submissions
One important advantage of Aegis’s product line is that each function and module has been developed from the ground up specifically for use in your regulated environment. Unlike most analysis and visualization tools, you can use results from Discoverant directly to support critical process decisions without the need for alternative validated confirmation.
Because the core functionality of Discoverant and PRIMR are validated by Aegis as part of our comprehensive quality system, only your product- and process-specific data models and data capture forms require separate validation on-site. As a result, your validation effort is significantly reduced, allowing you to achieve your return on investment much more quickly.
Aegis performs extensive testing on all of its products using the same discipline to develop, execute and document test scripts, protocols and product testing as is required by the most recent guidelines.
To support your on-site validation of the Aegis products, Aegis makes available an optional Validation Kit. This kit, containing key templates and protocols can significantly reduce the amount of effort required to develop a validation approach. In addition to Aegis’s internal test documentation, the kit includes the following components:
Validation Plan template
User Requirements Specification template
Design Specification template
Installation Qualification Protocol
Operational Qualification Protocol
To support and assist our customers with their validation of Discoverant and/or PRIMR, Aegis can provide consultants to support your validation efforts. These consultants have many years of experience working in cGMP environments, and can assist in many areas of your overall validation process including:
Validation planning and validation project management
Validation Master Plan development
User and Functional Requirements development
Design Specification development
Customization of IQ / OQ / PQ protocols
As part of its Professional Services offering, Aegis provides Project and Program Management services to support your implementation and validation requirements.
Aegis certified Project Managers from Aegis or from one of our Implementation Partners, have extensive experience in Project Management and in Aegis’ Passport implementation methodology. Our Project Manager works with your Project Manager using the Passport tools and templates to ensure that Discoverant and/or PRIMR projects are delivered on-time and within scope and budget.
For multi-site rollouts, Aegis’s Program Management is available to make sure that each project has the appropriate resources when and where needed. The Program Manager works with each Aegis Project Manager to coordinate across multiple projects and deliver accurate consolidated reporting.
Aegis Analytical Corporation is proud to offer user and technical training to help you realize the benefits of Discoverant immediately upon implementation. These classes are designed to teach you everything from the basics of navigation to hierarchy administration. Aegis will also gladly customize a class to meet your organizations specific needs.
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Course Title |
Objective and Description |
QuickStart Program |
3-day introductory Discoverant User Training course. Includes basic use of the following modules and/or concepts: Starting Discoverant, Table View, AG Creation, Plotting, Statistics, and Quality Monitor. |
Discoverant User Training |
5-day Discoverant User Training course. This course focuses on basic and advance concepts and can be separated into two lesson groups that provide detailed instruction on the uses of Discoverant. Training includes Quality Monitor, Statistics, Curve Metrics, Visual Process Signature, Multi Phase Analysis, Plotting, Stability and Expiration Dating, AG Creation, Table View and Manual Data Entry. |
Basic PRIMR Training |
1-day course designed for the beginner PRIMR user. Students will learn the basics on entering data into the PRIMR system, creating and managing template instances, troubleshooting and resolving data entry errors, the concepts of 'check-in' and 'signature', and handling reconciliation returns. Students should have an understanding of Microsoft Windows and be comfortable using a keyboard and mouse. Students should also have experience using browser-based applications.
**This course may be combined with the PRIMR Designer Training Course. |
PRIMR Designer Training |
2-3 day hands-on course for the PRIMR Designer. Course includes lecture and hands-on exercises on the rules and configuring of Record Template classes, including the basic structure of Record Template design, logical units, forms, double blind entry, automatic and manual reconciliation. Students will use the Rich Text Edit Control to create and manage form templates as well as learn the basics of the PRIMR Workflow.
**This course may be combined with either the Basic PRIMR Training course or the PRIMR Administration Training course. |
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Course Title |
Objective and Description |
PRIMR
Administration Training |
1-2 day hands-on course for the PRIMR Administrator. Students should have administration experience with Windows 2000, IIS and Active Directory. Course includes lecture and exercises on the installation and configuration of the PRIMR server, basic administration tasks such as creating and managing users and groups with Active Directory, assigning user and group roles, configuring export for external storage and reporting capabilities.
**This course may be combined with the PRIMR Designer Training course. |
Implementation Training |
4- day hands on technical course. Course objective is to teach how to successfully implement Discoverant. Course includes lecture and hands on exercises on the installation of Discoverant, middleware, connectivity server and Java. Students learn the process of building simple to complex hierarchies from a simple manufacturing ‘recipe’. Students learn to work with the middleware, construct views, and complete a data model. Some basic uses of Discoverant include creating Analysis Groups and using Table View. This class also includes introduction to advanced subjects, such as Connectors and Bill of Materials. |
Discoverant
System Administration |
4-day hands on technical course for Discoverant Administrators. This course may also be useful for Users who have the responsibility of creating hierarchies for their organization. Course objective is to introduce new Discoverant Administrators and technical users to basic administration of the Discoverant server, client, as well as post-implementation tasks and hierarchy administration. Students learn to create users, set system parameters, and create/administer user groups at the beginning of the course. The remainder of the course is dedicated to lecture and hands on exercises of how to create simple to semi-complex hierarchies from a simple manufacturing ‘recipe’. Introduction to the middleware, view creation, importing and testing hierarchies is also included. Some basic Discoverant tasks such as creating Analysis Groups and use of Table View are included. |
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