What does your company want/need?
What regulations do you need to comply with - GLP, GMP, FDA, EMA, ISO, etc?
Do you need any documentation created, including templates?
Is a document management system required?
Do you just want a second set of eyes to review your documentation?
I N T E R V I E W
What does your company have?
Are all regulatory requirements fulfilled?
Are all processes and procedures documented?
Do any active documents cover processes or procedures that are no longer performed?
Is all instrumentation fully documented (IQ/OQ/PQ)?
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.
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
We will perform a final gap analysis and correct any deficiencies that are found.
We will continue to work with you until your documentation meets all compliance requirements.
Our work isn't done until you say it is.
R E V I E W