FDA Compliance

Solutions by MasterControl for the Challenges Involved in Sustaining FDA Compliance

Attaining FDA compliance can be a challenge in itself, but sustaining compliance year after year can be overwhelming. Life science companies can no longer rely on paper-based or partially automated systems to manage their processes or documentation. This is particularly true for companies that have facilities at more than one site or use contract services. When it comes to FDA compliance, a centralized electronic system is just no longer optional.

FDA Just Called! Now What?


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MasterControl's Document Control, Document Management and Process Management for FDA Compliance

MasterControl provides document management software (MasterControl Documents), compliance software and eProcess Automation software (MasterControl Process). Together, these solutions can help companies sustain FDA compliance year after year.

Consolidating your documents into one centralized repository via MasterControl's document management application makes it easy to locate and retrieve documents. It also organizes all documents related to quality processes such as Customer Complaints, CAPA and Training.

MasterControl's eprocess automation software is the basis for automating manual processes. The eprocess solution involves circulating a form electronically for task performance, approval and signoff. When you multiply by 20 or 30 the impact that a single form-based process can make, you get an idea of how it can enhance both efficiency and FDA compliance.

FDA Compliance with Document Management Applications for Small Life Science and Tech Companies

If your company is looking for a document management application that is reasonably priced, takes care of validation, and assures FDA compliance, learn more about:

  • MasterControl GCPDocs Spark Document Management Software (for Pharmaceutical and BioTech companies)
  • MasterControl DHF JumpStart™ Design Control Software (for Medical Device companies)

For More Information on FDA Compliance Solutions

For more information about your MasterControl options and FDA compliance and approval, please feel free to contact a MasterControl representative.