capabilities » auditability
Pharmaceutical and Medical Device Company Audits

Audit Management Software Solution

In the world of regulated businesses, it’s not a matter of “if” your quality system will be audited. It’s a matter of “when.” InfoStrength takes the stress out of audits by providing an audit management software solution. Attain and maintain compliance by automating, streamlining and managing the audit process and meeting the demands of the auditor.

FDA Audits are conducted to ensure your business is operating in a way that supports the approved use of your products, as well as the maintenance and improvement of product quality and safety. Audits by sponsors and partners are conducted to ensure that you will be able to support their regulatory obligations.

InfoStrength’s reports help collect and track data to streamline the audit process by:

  • Identifying when a document was created, modified or deleted
  • Capturing changes made to a document
  • Tracking who made modifications
  • Recording date and time changes were made
  • Requiring the person who made the change to provide a reason for modification
  • Providing custom audit trail reporting with print, save and export options to meet the precise need of the auditor
  • Including 21 CFR Part 11 compliance features
Preparing for an audit is a daunting task. Add On-Call Quality Support to your solution to help you achieve a successful audit.

Contact us today to learn how InfoStrength can be your audit management software solution.

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