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While federal regulations
such as 21 CFR Part 11 and HIPAA (Health Insurance Portability and
Accounting Act of 1996) can be complex and oftentimes confusing,
they are a reality. When organizations compete in regulated environments,
they must ensure electronic compliance.Information Architecture
Team understands the complexities associated with meeting regulatory
requirements and offers pharmaceutical, medical products and life
science companies a viable solution to such regulations as 21 CFR
Part 11 and HIPAA.
We
offer 21 CFR Part 11 Compliance Assessments of computer systems,
software and data management systems. This is accomplished
through: |
Completion of a documented and approved strategy that contains
computer system classification Part 11 Compliance Assessment
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A summary report of the assessment findings |
A
Remediation Strategy Document, which is a plan of action
in achieving compliance in the case of Part 11 shortcomings |
Training
and documentation packages are also offered, and in most cases,
recommended. This, when coupled with our PETL™ (Pre-Extract,
Transfer and Load) methodology, ensures that data is transferred,
archived, manipulated, retrieved and distributed in a safe, secure
and timely fashion through use of quality systems that are assured
to perform with absolute integrity.
Achieving HIPAA compliance
requires strategic planning and integration into all areas of your
organization. Our HIPAA program:
Identifies the right internal participants from all areas affected
by HIPAA within your organization |
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Develops a comprehensive work plan to be followed throughout
your HIPAA Compliance Implementation project |
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Presents timelines and budgets for each phase of the project
to your executive team |
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A Remediation Strategy Document, which is a plan of action
in achieving compliance in the case of Part 11 shortcomings
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Enables
your HIPAA team to effectively manage time and maintain other
organizational responsibilities |
This allows organization
to:
Analyze collected data and compare outcomes with HIPAA requirements |
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Determine data-centric changes necessary to comply with HIPAA
mandates |
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Identify special considerations and problem areas in key business
processes as they pertain to your data structure |
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Remediate the processes that will provide the greatest decrease
in organizational and regulatory risk |
We understand that regulatory
compliance is a journey and not a destination. 21 CFR Part 11 and
HIPAA each represent the opportunity for organizations to achieve
current and future objectives and mandates, while taking strides
in the new economy by using advanced IT-based solutions.
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