35
Advisory, development, and strategic planning services
provided to companies for business purposes in the life
sciences industries; business consultation services in the
life sciences fields featuring end-to-end GxP ("Good
Practice") cloud compliance from implementation through
ongoing validation maintenance of new releases, product data
integration into a modern Quality Management System (QMS) to
create more efficient workflows, clinical collaboration in a
GxP compliant environment, computer Systems Validation
(CSV), enterprise content management systems, workflow and
eSignature approval streamlining, digital transformation
strategy and roadmapping and application consolidation,
including email, document management, file transfer protocol
(FTP) servers and file share drives, merger and acquisition
standardization and harmonization, document management
systems, GxP compliance for FDA audits, EU audits, and other
regulatory agencies, reducing implementation and validation
time, harmonizing and centralizing GxP cloud compliance,
cost reduction for managing cloud compliance, new release
management for continuous cloud compliance, scalable vendor
solutions for establishing compliant IT foundations, vendor
audits targeted to current processes, technology, and
manufacturing, implementation and validation of GxP
compliant changes, including regulatory assessment, creation
of validation plans and reports, drafting of user
requirements and functional specifications, risk and impact
assessment, developing IQ/OQ/PQ protocols and test scripts,
developing user and administration SOPs, continuous GxP
compliance, including managing new vendor releases,
conducting impact assessments, updating validation
documents, running automated regression tests, and providing
continuous analysis and reporting
41
Providing educational and informational content and
customized training materials and programs in the life
science fields through various print and electronic
multimedia, including: videos, blogs, articles, webinars,
white papers, onsite/offsite remote channels, workshops,
hands-on training programs, and other training environments
in the life sciences fields, including but not limited to
the following subject matter: end-to-end GxP ("Good
Practice") cloud compliance from implementation through
ongoing validation maintenance of new releases, product data
integration into a modern Quality Management System (QMS) to
create more efficient workflows, clinical collaboration in a
GxP compliant environment, Computer Systems Validation
(CSV), document management systems, enterprise content
management systems, workflow and eSignature approval
streamlining, digital transformation strategy and
roadmapping and application consolidation, including email,
document management, file transfer protocol (FTP) servers
and file share drives, merger and acquisition
standardization and harmonization, GxP compliance for FDA
audits, EU audits, and other regulatory agencies, reducing
implementation and validation time, harmonizing and
centralizing GxP cloud compliance, cost reduction for
managing cloud compliance, new release management for
continuous cloud compliance, scalable vendor solutions for
establishing compliant IT foundations, vendor audits
targeted to current processes, technology, and
manufacturing, implementation and validation of GxP
compliant changes, including regulatory assessment, creation
of validation plans and reports, drafting of user
requirements and functional specifications, risk and impact
assessment, developing IQ/OQ/PQ protocols and test scripts,
developing user and administration SOPs, continuous GxP
compliance, including managing new vendor releases,
conducting impact assessments, updating validation
documents, running automated regression tests, and providing
continuous analysis and reporting
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