|
About eTechDocs.com
Core Vision
To lead the software industry with strategic and business focused
technical writing and documentation services. eTechDocs.com and
its employee's strive toward this goal by providing knowledge, experience
and hard work with the understanding of how technology and documentation
come together to the companies it serves.
Industry Background
Our unique synergy strategically
blends a background of business, software engineering and regulatory competencies.
Listed below is an example of the diversity and experience we can bring
to your organization:
Proven background with Fortune 100 pharmaceutical and biotechnology companies
Regulatory/validation assessments
Specialize in compliance issues (i.e. 21 CFR part 11, GMP)
Risk management/risk assessment
IQ/OQ/PQ (preparation and execution)
Test planning (test case/script documentation and execution)
Requirements management (gathering and documenting)
GAMP, Rational Unified Process (RUP), IEEE
Audits (internal and vendor)
FDA warning letters (483's), (response and corrective action)
Strategic development of policies and procedures (SOPs)
Software engineering and architecture
For more information about our company please contact
us.
|
