Soft Source consultants provide on-site computer/process system validation to our growing list of world-class clients to help them in their contract employment needs. Our skilled engineers and Subject Matter Experts (SMEs) have experience in several key competencies and service areas including:
- cGMP
- GCP/GLP/GMP
- IS0-9000
- GAMP
Soft Source Inc.'s value added services provide specific job functions to help pharmaceutical, biotechnology, drug delivery and medical device companies meet their performance and FDA compliance goals:
- Computer Systems & Equipment Validation
- Commissioning and Startup Support
- Writing, reviewing and executing IQ/OQ/PQ protocols
- Typical Systems, Platforms & Environments
- Process Validation & Media Fills
- cGMP Audit and Consulting Services
- Quality Assurance
- GMPs
- Process Automation & Controls
We also offer resources experienced in Supply Chain Management Systems and the use of computer applications such as:
- Oracle Clinicals
- ClinTrial
- ClinPro, PIMS
- ERP / SAP
- Electronic Data Management Systems(EDMS)
