What We Do
Create and Edit Documents
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)?
Do all documents follow the same conventions for naming, numbering and formatting?
The first step is to determine your company's needs:
What regulations do you need to comply with - GLP, FDA, EMA, ISO, etc?
Do you need all documentation created, including templates?
Do you just want a second set of eyes to review your documentation?
We will provide whatever services you need in the timeframe you need them.
We review all existing documents. Some of the things we look for:
We will perform another gap analysis and work with you to make sure that all documentation requirements have been met.
Our work isn't done until you say it is.
Our services include any or all of the following, depending on your company's needs.
We will present our findings and work with to develop a plan for completing the documentation process.
We will create and edit the needed documents - in close collaboration with the subject matter experts. We work closely with the SMEs to make sure that the documentation reflects the process and procedures as they are currently performed.
Additionally, we make sure that a consistent template is used for all documetation.