During commercialization, manufacturing begins producing inventory as quickly as possible, so that, once regulatory approval or clearance is received, sales can begin immediately. Manufacturing team members also complete their process validations and manufacturing procedures, and - based on marketing sales forecasts - develop long-term purchasing plans. Training operators on new processes and equipment is also important during this phase. MasterControl Training software can facilitate this process and ensure FDA/ ISO compliance (both of which require documented evidence of training and competence). As full-scale production gets underway, the quality assurance team implements the quality plan and begins playing an active role in making sure that all components, raw materials, and finished goods are in compliance with device master record (DMR) specifications. The quality team also investigates nonconformance issues, CAPAs, etc. MasterControl reporting and analytics software can help in this area. Process Automation software can also help during the commercialization phase, by automating the management of nonconformances, CAPAs, product changes, supplier audits, and deviations.
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|Controlled Documents Managed in the Commercialization Phase||Collaboration Workflows in the Commercialization Phase|
For more efficient and effective training on SOPs, work instructions, quality systems regulations (QSR), etc., MasterControl provides:
To get in-depth detail about medical device commercialization phase, contact MasterControl representative today.