Quality
& Compliance
Information Management
Systems
Professional Services
Laboratory Systems Consulting (LSC) is
a Professional Services organisation whose
knowledgeable and experienced team help
you define, select, implement
and support Information Management Systems
in the Quality and Compliance
functions. 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 their 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
combine life sciences experience with
innovative thinking to develop and implement
effective strategies to meet business
objectives. The Professional Services
are caregorised as follows :
- Strategic & Management
Consulting
- Application
Implementation & Support
- Regulatory Compliance/21
CFR Part 11
- Training
& Mentoring
Do you have any of these Challenges?
-
Do you want to develop an Information
Systems Strategy for your Quality Systems
that integrates your data with the rest
of the business in a complaint fashion?
- Do you want to select and implement
a Laboratory Information Management
System but do not know where to start?
-
Are you part of an Enterprise LIMS or
ERP implementation and need help?
-
Have you a LIMS system that needs to
be upgraded or retired?
-
Do you want an independent organisation
to oversee a project or the Validation
of a system?
-
Confused about 21 CFR Part 11 and need
help with Strategy and project management?
If the answer to any of the above
is YES, then you should contact us
at info@lims.ie.
Our Consultants have
experience across a whole range of Quality
and Compliancs related systems, Project
Management, 21 CFR Part11 and Computer
Systems Validation.
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 for existing systems. 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 into all our projects while
at the same time ensuring 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 havethe maximum chance of being delivered
On Time, On Budget to the appropriate
level of Quality.
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