Audits

In the highly regulated Pharmaceutical environment, it is critical that your company has the proper audit protocols in place. CIS can help via mock audits that would closely mirror what your organization would face during a real government audit. These steps include, but are not limited to:

  • Conduct Audits of policies and procedures, to evaluate the level of documentation and whether operational activities follow established policy and procedures.
  • Conduct data sampling for specific products and quarters to determine whether calculations and record retention are accurate and complete.
  • Provide feedback on your various departments' audit readiness, to determine preparedness in the event of a true government audit.
  • Provide specific Audit Recommendations, including the frequency, breadth and depth of Audit activities across the policies and procedures related to the specific departments reviewed
  • Write or re-write policies and procedures related to your Audit readiness