What is Compliance?
All industries are highly regulated, with numerous regulatory activities overseeing different aspects of development, manufacturing, and marketing. Compliance is the process of meeting a third party’s requirements with the aim of enabling business set-ups in a particular market or supporting with laws or even with a particular entity.
Need of Compliance in a Business
The truth is that the industries have long put forth massive efforts to develop compliance frameworks and guidelines. In case of non-compliance in any task execution it can be legally straining and notoriously demanding.
Well! A best practice for effective and efficient quality is achieved by BEING COMPLIANT.
Pharma industry is one among the major industries that have to follow strict compliance process in its area of works, one of the process being the Event Execution. Pharma industry is usually bound to plan and conduct multiple types of event every quarter. These event processes require lots of attention and several hands to get the act right.
Different Phases of Compliant Process for a Company
4 Phases of a Compliance Adherence .
| Phase 1 – Plan | Establish the system’s intent and goals. |
| Phase 2 – Do | Implementation and operation of Compliance procedures |
| Phase 3 – Check | The approvals matrix gives assurance by involving the subject owner nod in each process |
| Phase 4 – Act | Phase 1 -3 guides the phase 4 to be adherent and successful. |
How a Software Solution for Event Process Helps the Pharma Companies Achieve Compliance in this Area?
Software solution should adopt and adapt all the major compliance rules, for pharma companies to abide the good practices and fall in-line with the regulatory bodies. The solution should guide and help the resources involved in the process achieve the compliance seamlessly.
To mention a few
- Is HCP honorarium fee paid well within the set limit (Market value)
- Utilization of right HCP for the Event
- The required documents are available for execution of the events
- Have the execution personnel got required permission to conduct the event.
- Refer to compliance documents on one click
- Plan right and execute better
- And most importantly who is what and when in the discussed process
By adopting compliant software solution, scenarios that can be largely avoided –
- Speaker agreement not signed!
- Event is not approved by finance
- We have over paid the speaker
- Are they the right set of attendees for this event?
- This event is not by the rule book
- Speaker not verified and not approved
- Event not happened within the budget
- Last minute planning resulting in problems in coordination
Adherence to right procedures and good practices in compliance will ensure identification, prevention and management of risks in operations and statutory requirements.
The multiple departments that would highly be benefited with right compliance adherence are – Finance, Compliance, Legal, Marketing, Management to state a few.
Compliance not just raises alarms around risk and catastrophe areas, but also gives great opportunity for growth and makes way to new world of BUSINESS.
Author
Madhumalini. N
Associate Director
Email: madhumalini@vsmsoftware.com