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The company that files the IND is wholly responsible for product outcomes and FDA compliance until that product is no longer on the market or the company is acquired. FDA compliance, with respect to regulatory filing activities as well as development and manufacturing, is under the jurisdiction of specific GxP mandates. The technical, review, and collaborative aspects of FDA compliance can be very involved and expensive. Costs increase significantly when companies use external contract laboratory and manufacturing organizations. All processes and templates must be agreed upon in initial build out or contracting. If manufacturing is housed in a separate facility or global locale, communication can become difficult due to time zones and foreign languages.
With so much riding on the ability to maintain compliance, MasterConrol software for managing quality control processes such as nonconformances, CAPAs, customer complaints, change control, and training?only makes sense.
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include:
|Batch Records||GCP Document Management||Document Control|