Services

Following are some examples of the services we offer. Please contact us to discuss your needs.

• Business Analysis
• Laboratory Information Management Systems (LIMS)
• Chromatography Data Systems (CDS)
• Statistical & Data Analysis
• Project Management
• Computer Systems Validation

Business Analysis 

Some of the keys to project success are a comprehensive set of requirements, and identifying the best opportunities to automate and streamline the business.

Some Business Analysis related activities:

• Requirements definition & analysis
  • Taking into account the needs of the business, regulatory agencies, and company strategy
  • Prioritization of requirements
• Feasibility Studies
• Vendor Evaluations
  • Request for Proposals (RFP)
  • On-site assessment and/or pilot
• Business and Process Analysis
• Strategies

LIMS 

LIMS systems and the management of laboratory data are essential to day-to-day laboratory operations.

Some activities associated with LIMS projects:

• Requirements gathering
  • Out of the box and custom functionality
• Regulatory requirements (such as 21CFR Part 11)
• System evaluation and selection
• Identifying opportunities for process harmonization
• Identifying and prioritizing opportunities for automation, such as
  • Instrument integration
  • Custom calculations
  • Statistical analysis
  • CDS integration
• System configuration, such as
  • Specifications, tests, & calculations
  • Custom database tables and fields
  • Reports
• Data migration

CDS 

Chromatography systems are the heart of many analytical laboratories, and are unique in the sense that a lot of lab equipment needs to be integrated with the system, and the rollout needs to be done with minimal impact to day-to-day lab operations.

Some activities associated with Chromatography projects:

• Requirements gathering
  • Out-of-the-box and custom functionality
  • Reports
• Regulatory requirements (such as 21CFR Part 11)
• System evaluation and selection
• Identifying and prioritizing opportunities for automation, such as
  • Custom calculations
  • Statistical analysis
  • LIMS integration
• Robust rollout and training plan

Statistical & Data Analysis 

Laboratories produce a wealth of data. How do I get to the data? How do I analyze it? Statistical & data analysis software answers these questions by providing ready access to data and automating manual data analysis.

Some activities commonly associated with Statistical and Data Analysis projects:

• Requirements gathering
  • Pulling data from multiple systems
• System evaluation and selection
• Regulatory requirements (such as 21CFR Part 11)
• Identifying and prioritizing opportunities for analysis, such as
  • Data trending
  • Process capability
  • "What If" scenarios

Project Management 

Full lifecycle project management for all major project phases, from initiation through closure.

Some typical project activities:

• Project justification
• Clearly identifying the scope of the project
• Project qualitative and quantitative benefits
• Risk identification & mitigation
• Timing & budgets
• Resource estimates
• Vendor negotiation and contracts
• Project planning & management
• Training plans

Computer Systems Validation 

Complete range of validation documents commonly utilized in FDA-regulated environments:

• Validation planning
• Quality risk assessments
• Change Control
• Requirements
• Design Specifications
• Trace Matrix
• Test Planning
• Test Coordinator
• Installation Qualifications (IQ)
• Authoring / Execution of test scripts
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • User acceptance testing (UAT)
• Validation Reports
• Standard Operating Procedures (SOP)