Products & Services

Our client service resources are experienced professionals that have worked or provided services to major companies in the pharmaceutical manufacturing, government, insurance and other industries in Puerto Rico and abroad.

Mobile Apps Development

Creating Smarter Apps

 

Together we can help your organization to:

  • Analyze the data received
  • Reduce costs and optimize resources
  • Expand your business idea
consulting
IT Consulting

Over 24 years of IT experience in the consulting and internal support areas for general and FDA regulated industries.

  • Project Management
  • Application Systems Implementation
  • Systems Development Life Cycle (SDLC)
  • Hardware Analysis and System Configuration

government
IT Governance

We know, apply and continuously learn about recognized IT best practices to support the success of client IT area.

  • IT Strategic Plan Alignment
  • Risk Assessments
  • Impact Assessments
  • Disaster Recovery Plans
  • Remediation Support

compliance
Validation

Solid hands-on experience in the complete life cycle for Computer Systems Validation (CSV).

  • Full CSV Life Cycle Execution Support
  • cGMP Assessments
  • Project Management
  • Documentation: VP, URS, SDS, IQ, OQ, PQ, Reports
  • Retirement Plans

 
validation
Compliance

Experience in support to Quality Assurance processes and systems to ensure compliance with established Quality Standards.

  • Regulatory Compliance
  • Risk Assessment
  • Audit readiness for cGMP, SOX
  • Periodic Reviews for cGMP Systems
  • Change Control Support
  • Quality Reviews Support

documents
Technical Documentation

Expertise in the development of professional technical and process documentation of clients operations.

  • Company Policies
  • SOP’s and Work Instructions
  • User and Technical Manuals
  • Retirement, Test and Data Migration Plans
  • System Diagrams and Process Maps

mobile development
Specialty Products

Constantly searching and learning about new and unique solutions to add value and improve decision making process for our clients. Together we can help your organization over a mobile solution to:

  • Data Analysis
  • Cost Reduction and Resources Optimization
  • Expand Business Ideas

 

DocsTrack

The best mobile app to track your documents.

 

OUR CLIENTS

Management Team


ismael

Ismael A. Avilés Camacho / CTO

Professional Engineer with 10+ years’ experience in communications technologies, project management, Computer System Validation (CSV) and compliance services for the pharmaceutical/medical devices manufacturing and other industries in Puerto Rico and the Caribbean.

 

Corporate Capabilities

      IT Consulting and Governance

Computer Platforms and Mobile Applications Development.

 

Computer System Validation and Compliance

CONTACT US

PMB 470, Box 4956 Caguas, Puerto Rico 00726
(939) 633-8587  
info@itcspr.com