Laboratory
Systems Consulting
Founded in 1995, Laboratory Systems
Consulting (LSC) is a Professional Services
organisation whose knowledgeable and experienced team help our clients
define, select, implement and support
Information Management Systems in the Quality and Compliance
areas. Achieving and maintaining compliance
with FDA 21 CFR Part 11 and European regulations
is a fundamental consideration.
Our Service 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.
Laboratory Systems Consulting is a
vendor/product independent organisation who
have extensive experience in Project
and Program Management, 21 CFR Part
11, and in implementing and integrating
Information technology systems across most of the major Business Applications
supporting the Quality and Comliance
functions.
These include systems, such as:
- Laboratory Information Management
Systems
- Chromatographic Data Management
Systems
- Enterprise Resource Planning Systems
- Corrective and Preventive Action
Systems (CAPA)
- Deviation Reporting and Management
Systems
- Adverse Events Reporting
- Vendor Management Systems
- Change Control Systems
- Document Management Systems
Laboratory Systems Consulting combine
life sciences experience with innovative
thinking to develop and implement effective
strategies to meet business objectives.
Our Professional Services are categorised
as follows :
- Strategic Management Consulting
- Policy definition and
implementation
- ISO9000, TickIT and ITIL
implementation and support
- Application Implementation
& Support
- Regulatory Compliance
- Risk Assessment & 21 CFR
Part 11 Compliance
- Computer Systems Validation
Support
- Training / Mentoring
Methodology
Addressing Business Change and Technology
Innovation in a holistic way is a major
challenge, whether implementing a new
system or ensuring 21 CFR Part 11 compliance.
Both must be addressed as part of the
overall project and must be viewed as
a major component of any initiative.
At Laboratory Systems Consulting we
incorporate business change and technology
innovation iinto all our projects while
at the same time ensure that all the
necessary steps are taken to ensure
that the project is delivered On Time
and On Budget.
First, we listen to - and understand
- your unique set of conditions before
we design and plan the systems you need
to achieve market success. Through a
powerful blend of management and technical
expertise combined with substantial
industry knowledge, we collaborate and
integrate with your
business and technology leadership teams
to define business architectures and
processes.
We then work with the team to implement
the systems and applications that deliver
added value to your business.
People, Processes and Technology
Technology innovation alone does not
result in project success.
At LSC we believe that dealing in a
holistic way with fundamental management
principles, business change and technology
innovation will deliver on the business
case and project benefits for the organisation.
The basic units of this holistic approach
are :
People: Get the correct
people on the project with the right
attitude, authority, responsibility
and motivation.
Key decisions need to be made by these
people who must be empowered.
Processes: Carry out
Business Process review and redesign.
Optimise and integrate these processes
where necessary.
Technology: Select
the appropriate technology that delivers
the defined business processes in an
integrated,
secure and compliant fashion.
By ensuring that these three cornerstones
are addressed correctly and by applying
fundamental management principles of project management, change management
and continuous improvement, projects
undertaken have the maximum chance of being delivered
On Time, On Budget at
the appropriate level of Quality.
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