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Quality Assessments & Auditing |
| We provide complete assessment and
audit reports including detailed recommendations for
system improvement, ways to reduce regulatory risk, and
increase business efficiency based on industry best
practices. |
| Some of the services we offer are: |
- Quality System & compliance
assessments
- Development and management of
Internal Quality Audit programs
- Development and management of
Supplier Quality Audit programs
- FDA QSIT, ISO 13485, ISO 14971,
and ISO 9001 assessments & audit preparation
- MDD, IVDD, CMDR, and FDA
Part 11 assessments & audit preparation
- Mock FDA Inspections
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Quality System Design & Implementation |
| We offer comprehensive quality system
and regulatory compliance leadership for the creation or
re-design of quality systems. We work closely with your
team to develop and author individualized quality system
policies and procedures to enhance your compliance
efforts and support your specific business needs. |
| Some of the services we offer are: |
- Quality System design & deployment
- Quality System gap analysis & re-engineering
- Document and Change Control business systems
- Data & Records Management business systems
- Design Control strategies & process development
- Development and implementation of CAPA programs
- Development and implementation of Complaint
Handling systems
- Nonconforming Material programs & management
- Process Validation programs & assistance
- FDA Facility Registration assistance
- Recall & Field Correction assistance
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Software Configuration, Validation & Implementation
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| We support clients throughout the
process of automating business processes through
Off-the-Shelf software applications. |
| Some of the services we offer are: |
- Defining system requirements and assisting in
the preparation of Requests for
- Proposals & Quotes (RFP & RFQ)
- Assistance in selecting appropriate software
applications to meet individual compliance needs and
business goals
- Development of functional and technical
specifications for software applications
- Configuration of software applications to meet
individual business processes
- Software Validation (IQ, OQ, PQ)
- Assistance with document and data migration
- Technical IT support
- Software application integration
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Project
Management |
| Effective project management is
critical to the success of any quality system
implementation or re-engineering effort. We offer
comprehensive project management services for the
complete life-cycle of the implementation or
re-engineering effort, including PM support for any
software application configuration, validation, and
implementation efforts. We work closely with your
implementation team to ensure the project is completed
with the highest quality, on time, and within budget. |
| Project management professional
services include: |
- The Project Manager assigned to the project will
work closely with the client’s implementation team
to define and document major tasks, milestones,
deliverables, timelines, and resources needed to
successfully complete the project.
- S/he will act as liaison between implementation
personnel, management, and vendors by conducting
meetings to review project details and obtain
necessary reviews and approvals.
- S/he will monitor all phases of the project,
review status reports, and modify schedules or plans
as required. The Project Manager will also
prepare regular project reports for the client and
other defined stakeholders.
- The Project Manager will confer with project
personnel to provide technical advice and to resolve
issues.
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Regulatory Compliance Training |
| We will assist you in developing an
efficient and compliant training system that works for
your business. Additionally, we can create customized
training courses designed specifically for audiences
ranging from the executive board room to manufacturing
operators/technicians to field service personnel. |
| Some of the customized training
services include: |
- Instructional design
- Content development
- Expert delivery in a variety of class formats
- Testing and/or evaluation of effectiveness
- Certificates of completion or training records,
as appropriate
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Regulatory
Affairs Assistance |
| We provide full-service regulatory
affairs assistance to support your product development
pipeline and emerging technologies. |
| Some of the services provided
include: |
- Strategic planning
- Clinical study protocols & IRB approvals
- Bio-Informatics and statistical analysis
- 510(k) and PMA submissions
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Quality
Assessments
& Auditing