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Validation Consulting |
understanding guidelines and regulations
"The FDA's analysis of 3140 medical device recalls conducted
between 1992 and 1998 reveals that 242 of them (7.7%) are attributable
to software failures. Of those software related recalls, 192 (or 79%)
were caused by software defects that were introduced when changes were
made to the software after its initial production and distribution."
General Principles of Software Validation; Final Guidance for
Industry and FDA Staff
Praxis Life Sciences excels in Planning, Development, Documentation, &
Deployment (PD3) in regulated environments. Our associates have been
involved with all aspects of validation under FDA guidelines and regulations
including GMP, GLP, GCP, Computer Systems Validation (CSV), and 21 CFR Part
11. The list below includes some of the activities our associates have
performed.
Validation
- Compliance Auditing
- Retrospective Evaluation of Legacy Systems
- Functional Requirements and System Design Specifications
- Test Plan Development and Execution
- IQ/OQ/PQ Protocol Development and Execution
- Change Control and Document Control
- Validation Certification Package Development
21 CFR Part 11
- Part 11 Gap Analysis, Remediation Planning and Execution
- Part 11 Global Compliance Auditing
- Part 11 Interpretation and Consulting
- Gap Remediation
Validation Studies and Data Analysis
- Direct and Coordinate Study Implementation
- Develop and Execute Protocols
- Data Analysis and Report Writing
- Submission Summaries and Analysis Reports
Software Quality Assurance (SQA)
- SQA Program Development
- SQA Auditing
- SQA SDLC Design, Implementation, and Evaluation
- Change Control and Configuration Management
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