Change Control Software

The 3 key challenges facing Generic Drug and API Manufacturers today in relation to change management are:

  • Assessing the impact of product and process changes across functions
  • Executing product and process changes with clear definition of roles & responsibilities
  • Identifying the right measures that drive the desired behavior, business performance and outcomes

By utilizing an automated Change Control solution Generics Organizations can meet these challenges head on. By conducting a detailed Impact Assessment and getting feedback from all parties involved, ensures that the implementation phase of the change will be more effective.

An effectiveness review at the end can ensure that the change control met its goals of completing the change as initially requested and all the supporting information is correctly captured. Change Control Trend reports provide a full 360 degree view on the patterns and trends that will help the organization improve its change control process.

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
- Reduce costly product recalls
- Reporting by product in dashboard format to review efficiencies and identify process improvement opportunities
- Manage change control efficiently for cost reductions
- Spend less time on audits, including Agency, Vendor, Client and Internal Audits
- Gain greater Control over your Supply Chain

Alternatively, check out this Change Control Process Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to Change Control Management.