DistinctHorizon Corp. - Life Sciences Software

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Professional Services

Consulting

DistinctHorizon provides consulting services in the following areas through its Subject Matter Experts (SME) network in document and knowledge management, regulatory affairs and quality control:

21 CFR Part 11 Compliance
System Validation
Regulatory Affairs
Regulatory Submission and e-Submission
SOPs and process solutions
GxP
Clinical Trials
Laboratories and Manufacturing ISO Deployment
Paper to Electronic Document, Imaging
Knowledge and Document Management

Deployment

DistinctHorizon provides deployment services throughout North America and Europe. Implementation schedule and compliance assessment should be done through an initial gap analysis of processes and methodology in place. Deployment can take anywhere from 2 to 16 weeks depending on the organisation business case. Deployment methodology follows Fujitsu Consulting’s Macroscope. Contact us for more information about our deployment services.

Training

Our training programs are focused on a knowledge transfer approach allowing organisations to receive all necessary information and documentation for the day to day use of the corresponding solution in their respective environment. The training is available on site, offsite or trough the Internet.

Validation

DistinctHorizon's provides validation and project management consulting for the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications such as 21 CFR part 11. Services include gap analysis, remediation plans, SOPs, vendor audits, and training.