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Regulatory
Assessment and Validation
Tribiosys provides technology-based
services pertaining to international regulatory compliance
(e-submissions, Computer System Validation, 21CFR Part
11/ HIPAA, ICH guidelines, Common Technical  Document). Services
include validation and 21 CFR Part 11 gap analysis, mitigation/redeployment/remediation,
master and system-specific planning, training and SOP
development, and archival, storage and retrieval solutions
for current and legacy software environments. The Tribiosys
computer systems validation approach integrates industry
standard software development life cycle (SDLC) and software
quality assurance (SQA) methodologies with relevant validation
compliance best practices. Specifically, Tribiosys has
experience planning and managing validation projects including:
- Validation to GLP, GCP, GMP
standards
- Gap Analysis and Risk Assessment
- Development of Validation Documentation
Suite including Validation Master Plan, URS and
FRS, Traceability Matrix, Policies, SOPs, Work Instructions,
Validation Protocols (IQ, OQ and PQ), Validation
Reports (IQ, OQ, PQ)
- Change Management and maintaining
a continuous validated state
- Rollout of validated applications
to additional sites.
Tribiosys also has
the expertise to design systems that incorporate cGLP,
cGMP and cGCP requirements, as well as systems that support
compliance to these quality-related regulations.
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