Generic Drug and API Manufacturers spend a disproportionate amount of time auditing themselves, their suppliers, and responding to audits that their customers and sponsors conduct of them. Audits are an important element of compliance and exist to ensure independent review of systems and processes to alert to conditions that may become future issues. By using the automated Audit Management Solution from QUMAS, organizations can ensure that all non–conformances, observations and recommendations are recorded, tracked, updated and resolved in compliance with the time lines expected by the auditor or as required by law. Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS Audit Management process, allowing for observations to be recorded, reported and tracked for closure with an action plan executed to the satisfaction of both parties.
Watch this webinar to learn How Generic Drug Manufacturers can Reduce Cost and Time to Market with a Global EDMS/QMS
- Improve Quality Control across the organization on a local and global basis
- Reporting by product in dashboard format to review efficiencies and identify process improvement opportunities
- Spend less time on audits, including Agency, Vendor, Client and Internal Audits
- Respond quickly to audit findings
- Gain greater Control over your Supply Chain