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The basic motive of compliance management is to ensure that all employees required for the smooth running of a facility act responsibly. Therefore, being vigilant about the standards can have a direct or indirect impact on the products produced. Because to sustain in the present market situation, it is more important to be pro active than reactive. Consequently, audits also help in protecting companies from potential criticism . Compliance management is a central safety management component that can be effectively performed with integrated, automated data management tools. This is not rocket science. By acting diligently and creating complete transparency within an organization, many hidden risks can be discovered and resolved. The audit program and the corrective actions taken as a result assure that the company is operating according to established standards of practice. A compliance program can assist in preparing for the associated rigors of audit. Just as important, a compliance program can help to improve employee morale and productivity, and overall business performance. An effectively run compliance training program can begin to build and foster a culture of respect, ethical behavior and compliance. An audit checks for discrepancies between what is expected and what is delivered. The difference between these two is what can be called as “expectation gap”. Compliance management enables efficient management of the short comings of an audit as every pharmaceutical company has a commitment to their customers to provide highest quality drugs. Proper compliance management also allows easy tracking of nonconformance rectification thereby leading to corrective and preventive actions (CAPA). With extensive dashboard and drill through reporting, we can easily and instantly report compliance breaches at a particular site. This is a dynamic practice, because it can and will change as the needs change
I can see the answer provided by Mr Anil Lalwani is really sufficient .
Audit & compliance management workflow ensures the following.
Compliance between auditor & compliance management is the key line of External Audit other wise External Audit not beneficial for the company.
Audit and compliance management workflow will enhance:
Audit and Compliance are like nerves of any business and has to be checked regularly
the present invention relates to the area of workflow management systems.
- Compliance is either a state of being in accordance with established guidelines or specifications...
compliance workflow provides the baseline for audit assessment. Compliance is an operational function of the firm -- A business enabler following a risk based approach, a solution provider to meet organizational goals/objectives. whereas audit assures that the business operates properly in the light of approved policies and procedures.
Audit and Compliance Tasks are a mixture of scheduled and planned tasks and reviews as well as ad hoc tasks by reacting to incidents and inquiries.
The workflows for planned tasks, ensure that they are performed in the desired quality and within the framework of specified controls. The workflows are set up using the accumulated experience of knowledge of the team and ensure also efficiency. Team input for improvements is also important for team engagement. The workflows allow defined points to measure quality and efficiency.
The same holds true for ad-hoc workflows, while they add another important element. Like an emergency or evacuation plan, they allow to act fast and decisive in a high pressure environment.