Liquent Regulatory Solutions for Life Sciences

Home > Customers > Professional Services > Consulting

1. Implementation Services
2. Custom Development
3. Process Optimization
4. Validation Services
5. Consultancy Resources
6. eCTD Preparedness Program
   

i) Implementation Services

When it comes to implementing a business-critical software solution, the required steps go well beyond running through installation instructions and rebooting hardware.

• Is the appropriate hardware in place to run the new system?
• How will the new software application affect current business processes?
• Will it integrate with existing software systems?
• Is the appropriate infrastructure in place?
• What training needs will there be?

Liquent's implementation services take a holistic approach that begins by assessing current processes and then plans the appropriate roadmap to ensure a successful, efficient implementation:

Planning the Project

• Overall scope for an implementation project is developed during this phase.
• Liquent/client team is formed, roles/responsibilities are determined, and project management standards are established.
• Implementation workshop is held with the team.
• Once the project plan is produced, both project and executive review sessions occur.

Developing an Education Program

• Education program ensures that an organization moves smoothly from system implementation to productive use.
• A training needs analysis is built into every implementation.
• After the assessment, an education program is developed using Liquent's wide range of training options.

Analyzing the Business and Technical Environment

• Assessing the publishing environment from both a business and technical perspective is part of the Analysis phase.
• Liquent consultants look at numerous factors to achieve a detailed understanding, including current business processes, impact analysis, business requirement mapping, gap analysis, source document assessment, and technical and infrastructure analysis.

Building a Working Model of the Implementation

• A model or prototype of the planned implementation is built based on the output during the Analysis phase.
• The prototype defines and refines the publishing standards and process flows for the software system.

Confirming the Prototype

• To confirm the accuracy of the prototype, the implementation team uses the prototype model for a "trial run" of the end-to-end publication process.
• Acceptance tests are completed and any revisions to the process or infrastructure are made.

Deployment

• Once the prototype is confirmed, the system is deployed.
• Part of moving into productive use includes migrating data and reviewing the user education program, as well as internal validation and logging of any outstanding issues.

ii) Custom Development

Need expert development resources to customize your Liquent solutions? Just ask the people who developed the software.

Liquent Software Solutions is a development team dedicated to providing Liquent product customizations, including:

• Advanced custom reports
• Customization of Document Management System integration
• Customized add-ons
• Plug-ins for transformation and extraction
• Custom business services for rendering and publishing

As the developer of the CoreDossier, EZsubs, PDFaqua and the Insight suite of products, Liquent is uniquely able to provide first-hand system knowledge, which translates to shorter development cycles and increased accuracy.

In addition, we have access to an expanded API layer, which is only available in our development environment. Further, with our substantial development infrastructure already in place, we can manage your custom projects efficiently and economically. Most of all, our consulting team's significant technical and industry expertise ensures the solution we design meets your specific needs.

To ensure that we consistently meet or exceed your expectations with the highest quality results, Liquent creates a Scope of Work for each development project, based on your specific requirements.

iii) Process Optimization

From publishing tips to templates, our process consultants have an arsenal of support tools to streamline your submissions, as well as proven business process management and validation services. Liquent consultants work with the customer's business and technical user communities in an effort to articulate goals, objectives and strategies for managing, publishing and submitting Regulatory documents. In addition, the consultants work with our customers to define end user processes for using Liquent product(s) in the most efficient manner. Other benefits of these offerings include (but are not limited to): analyzing current business processes, applying innovative technological solutions, providing publishing and process expertise, documenting/creating system and user requirements, and documenting/creating ‘step by step' process guides for use of Liquent products. Furthermore, Liquent can recommend additional technologies and services for your total publishing lifecycle - from authoring to archiving.

With engagements at more than 85 global organizations, Liquent consultants have gathered tremendous knowledge of and experience in successful publishing environments.

• Should there be single Docbases or multiple?
• Are centralized publishing centers better than decentralized?
• What procedures work best for database administration and backup?
• How should cross-references be handled?

We can help you create a sound publishing roadmap and maximum return on your software investment.

The group identifies Best Practices for:

• Full lifecycle implementations
• Full lifecycle project management
• Business/technical/regulatory consulting
• Installation and process validation
• DMS integration

Some common topics include:

• Performance optimization for large submissions
• Electronic document review and approval
• Extracts
• Departmental publishing
• Latest regulatory guidances, such as CTD, eCTD and Structured Product Labeling

iv) Validation Services

Implementing software for any major business application requires proper system validation. Liquent understands your need for a system that is both FDA-compliant and quality assured. We provide services to assist in validation customization, as well as offer an invaluable validation source book containing testing scripts to make the job easier.

For example, our services for FDA validation include all the checks the FDA normally conducts - input quality, output quality, and process qualifications. Part of the validation process includes user acceptance and testing scripts. View Validation Sourcebook (62.5KB)

The Liquent Validation Sourcebook packages provide validation-ready documentation to expedite the validation/implementation process. These packages include thorough installation and validation scripts in order to ensure proper installation and to test the functional requirements of the associated Liquent product. Furthermore, a Traceability Matrix is included to map specific test scripts back to the corresponding functional requirement. The Sourcebook documentation spans the IQ, OQ, and PQ validation phases. In addition, templates are provides for all plan and summary documentation throughout the corresponding validation phases.

v) Consultancy Resources

Do you require additional staffing during critical projects or submissions?

We can provide a wide range of consulting resources - from regulatory and application to technical and publishing - to help you through crucial deadlines.

We can assist you with the following to ensure you are staffed appropriately:

• Installations, including DMS integration
• Regulatory consulting, such as eCTD Preparedness and SPL approach
• Publishing of reports and submissions
• Application, such as standard operating procedures, database migration, and project management
• Validation Preparedness and Readiness
• Business Process Analysis and Redesign
• Post-Deployment (Implementation) Support

vi) eCTD Preparedness Program

Designed for life science professionals who are currently compiling eCTD submissions or looking to do so in the future, this program includes five different components. Clients are can choose specific components according to their business requirements. These components include:

• eCTD Educational Workshop- 2 day workshop to increase awareness of the eCTD structure and its impact on the organization.
• eCTD Readiness Assessment- 3 week activity aimed at gaining an understanding of the client's business processes and templates used to create submissions.
• Authoring Configuration- Contributing authors (both internal and external) will be set up with an eCTD production environment.
• eCTD Document Conversion- Liquent will provide services to convert legacy documents into eCTD-ready documents.
• eCTD Regulatory Pilot- Liquent will provide services to convert a previously submitted dossier into eCTD format.