Document Management System
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Background
Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document control process. Document changes were taking an average of 50 to 60 days to complete. The company sought a compliant process with faster turn-around times.
RCA’s wealth of knowledge about our document management system & document control helped us speed up our process, halving the turn-around time.
Solution
Qualitest engaged Regulatory Compliance Associates® Inc. to improve the document change process. RCA quickly dove in to understand the document management software and current process to identify issues and areas for improvement. Together with Qualitest, RCA revised standard operating procedures to reflect the new process and embark on training with both users and management to pilot the new SOPs.
Result
The pilot of the new document change process was effective. The document version control also generated new feedback for further improvement by the client’s internal team. Qualitest incorporated the pilot feedback and rolled out the new process & document control system. Today at Qualitest, on average, document change takes place in less than 30 days and, in many cases, even faster.
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