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Professional Services
Laboratory Systems
Consulting is a Professional Services
organisation who can deliver a
wide range of services as outlined
below. The Service delivery model
is defined based on your
requirements. Consulting services
are available on site or remotely
depending on the project underway and
your budget constraints.
Our Services offerings focus on the
Pharmaceutical, Bio-technology, Food
and Life Sciences sectors. We help our clients to maximise and
optimise People, Processes and Technology
to meet your information needs
by providing services to integrate business
processes, information technology, and
regulatory compliance.
Our professional services couple industry
best practices in the Quality Systems
environment with strong project management
(or project recovery) to deliver on
time and on budget.
21 CFR Part 11 is a major issue at
the moment and LSC provide you with a
complete suite of Compliance services.
See the 2003 FDA Part 11 Final
Guidance http://www.21cfrpart11.com/files/fda_docs/part11_final_guidanceSep2003.pdf
See the
1997 FDA Part11 Final Rule http://www.21cfrpart11.com/files/library/government/21cfrpart11_final_rule.pdf
Call us today or email info@lims.ie
for details
Strategic
& Management Consulting
The following are some of the services
offered:
- Quality Informatics Strategic Planning
- Executive and Team Mentoring
- Quality Systems Design and
Implementatioon (ISO9000, TickIT
& ITIL)
- Organisational Design
- Global Processes Design & Optimisation
- Global Requirements Definition
- 21 CFR Part 11 Program
Management
- Business Case Development
- Program Management Office Design
& Implementation
- Project Management / Project Recovery
- Project Quality Assurance
- Project Mentoring
Application
Implementation & Support
The following are some of the services
offered:
- Application and Information Architecture
- Requirements Definition and Design
- Business Process Optimisation
- Application Selection
- Application Interfacing
- Application Implementation Support
- Training
- Project Management
- Project Recovery
- Post Implementation Review
Regulatory Compliance
The following are some of the services
offered:
- Systems Risk Assessment
- 21 CFR Part 11 Assessment and Support
- 21 CFR Part 11 Policy Definition
- 21 CFR Part 11 Project Setup and
Definition
- Inventory Gathering and Assessment
- Systems Integration
- Instrument Interfacing
- Computer Systems Validation Policy
definition and Assessment
- Information System Vendor Audits
- Mock Internal Audits
- Mock ISO9000 Audits
- Project Audits
- Project Validation Support
- Legacy Systems Support & Retirement
- Retirement Strategy and Support
- Implementation Support
Training/Mentoring
The following are some of the
Training services
offered:
- Computer Systems Validation
- 21 CFR Part 11 Awareness Training
- 21 CFR Part 11 Assessments
- Systems Based Risk Assessment
- Project Management
- Project Recovery
- Team building & mentoring
- Problem Definition and Resolution
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