OUR SERVICES
INTERVIEW
What does your company want/need?
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What regulations do you need to comply with - GLP, GMP, FDA, EMA, ISO, etc?
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Do you need any documentation created, including templates?
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Is a document management system required?
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Do you just want a second set of eyes to review your documentation?
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I N T E R V I E W
GAP ANALYSIS
​What does your company have?
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Are all regulatory requirements fulfilled?
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Are all processes and procedures documented?
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Do any active documents cover processes or procedures that are no longer performed?
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Is all instrumentation fully documented (IQ/OQ/PQ)?
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G A P
A N A L Y S I S
CREATE AND EDIT
We will create and edit the needed documents - in close collaboration with the subject matter experts (SME's) to make sure that the documentation reflects the process and procedures as they are currently performed.
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We also make sure that a consistent template is used for all documentation for continuity, as well as an electronic filing system to reduce redundancy of documents.
C R E A T E & E D I T
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REVIEW
We will perform a final gap analysis and correct any deficiencies that are found.
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We will continue to work with you until your documentation meets all compliance requirements.
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Our work isn't done until you say it is.
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R E V I E W
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