21 CFR Part 11, LIMS Services

By: Lims  05/12/2011
Keywords: professional services, systems consulting, Laboratory Systems


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.

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

Keywords: Laboratory Systems, professional services, systems consulting