Question $2$

For this question, you are required to complete the $$Compliance monitoring plan $$ for a Pharmaceutical Company section of the Excel spreadsheet you used for the ongoing project in Modules $5$ and $6.$ The compliance monitoring plan is the grey section of the $$Compliance risk management plan$$ tab $($Columns L to T$).$ You should already have a minimum of $12$ regulatory provisions $($which equates to $12$ rows$)$ in your compliance risk management plan with a control for each provision. You now need to assign a monitoring strategy to each control that you have suggested. To complete this section, you are required to do the following:

$$ Assign stakeholders: In the $$Monitoring stakeholders$($Column L$),$ decide which stakeholders are responsible for the monitoring of each control listed in Column I. For example, perhaps the CEO is responsible for monitoring a particular control.

$$ Suggest a method: Under the column $$Monitoring method$($Column M$),$ you are required to suggest a process for monitoring. For example, you could suggest a data collection process or an audit review.

$$ Decide on frequency: As a final step, decide on the frequency of the monitoring. The frequency of monitoring is dependent on the control, the assigned stakeholder, and the severity of the risk. In the sheet, there are grey columns with various frequencies such as annually, monthly, weekly, and so forth $($Columns N to T$).$ Insert the stakeholder into the frequency column you feel is relevant for the monitoring method you have suggested.

Once you have completed the monitoring plan, complete Question $2$ in the $$Monitoring rationale$$ tab where you are required to substantiate your decisions.

Question $3$

For this question, you are required to write a short rationale for your compliance monitoring plan to substantiate the decisions you have made. This rationale will be completed in the $$Monitoring rationale$$ tab which is the fifth tab in the spreadsheet. Select a minimum of five rows from your monitoring plan to write about $($i$.$e$.$ five controls with their accompanying compliance obligations, controls, and monitoring methods$).$

The following list guides you in answering the first rationale for the Control $1,$ but your answer must address each of these points for all five controls that you have selected:

$$ Regulatory provision: In Row $4,$ copy and paste the regulatory provision that accompanies the control so that you are able to easily refer to it$.$

$$ Risk level $($impact and likelihood rating$)$: In Row $5,$ write down the risk level that goes with the regulatory provision $($e$.$g$.$ perhaps C$5).$

$$ Monitoring stakeholders: In Row $8,$ substantiate why you chose the specific stakeholders to monitor the control.

$$ Monitoring method: In Row $9,$ provide your reasoning behind the chosen monitoring method for each of the five regulatory provisions.

$$ Frequency: In Row $10,$ provide your reasoning behind the monitoring frequency you suggested in the compliance monitoring plan.