Laboratory Systems Consulting
Specialists in 21 CFR Part 11, Quality & Compliance Information Systems.
 


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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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