Brighton Associates redesigns your MBRs/DHRs as a stand project or together with
your SOPs. A typical project for a combined SOP and MBR/DHR project will performed
in a minimum of four (4) phases:
PHASE I: PROJECT ASSESSMENT REVIEW (2-3 Days)
Brighton Associates, at no cost to the client, will come to your site and discuss
your issues and expectations prior to a consulting assignment. Most clients take
this time to:
- give us a tour of their site with a focus on document movement and usage.
-
allow as the opportunity to review some of their documents.
- discuss FDA audits,
findings and responses
- determine the scope and resource requirements for an
Assessment.
PHASE II: UNDERSTAND COMPLEXITY ASSESSMENT
We consider your MBRs or DHRs, (depending on your industry segment), the windows
to your processes. Most"
Right the First Time" monitoring of performance
is focused on the MBRs/DHRs due to the necessity to enter process or product specific
information into the MBRs/DHRs.
Since the
"How to Do" SOP information is where the bulk of the training effort
is being done at most companies, it is advisable to begin an assessment of your
SOPs with an assessment of your MBRs/DHRs so that the SOPs ability to be in sync
with the MBR/DHR can be reviewed.
PHASE III: CHALLENGE AND CREATE PROOF OF CONCEPT (POC) MODEL DOCUMENTS
Our approach is to take what we have learned during our PAR and PHASE II and re-design
a POC of the Filling Section of the MBR. This effort will take into consideration
both Orencia and Abilify products.
Simultaneously, BA consultants will be redesigning the 12 documents that comprise
the Specific SOPs for Filling Section. The goal of our POC is to demonstrate the
capabilities of our methodology to deliver quality MBRs and SOPs that are easy to
use, reduce the opportunity for error, reduce the amount of complexity and make
them capable of delivering an ROI that will justify your investment. All documents
will be delivered in MS Word 2007.
