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Strata Skin Sciences

Strata Skin Sciences, a medical device company specializing in innovative dermatological solutions, is FDA-registered and ISO-certified. Committed to maintaining the highest quality standards, they needed to transition from a paper-based training system to an electronic system due to FDA regulations (21 CFR). While their Carlsbad production facility housed approximately 40 employees, this represented only a third of their total workforce. In addition to the Carlsbad facility, other employees across different locations also required training, making manual tracking inefficient and prone to errors.

Case Study Reviews:

  • Inefficient Tracking: Training records were managed on paper, making it difficult to determine who had completed necessary training.
  • Compliance Risks: Manual tracking led to occasional lapses where employees were found to be untrained on required procedures.
  • Scalability Issues: The company lacked a centralized database for training oversight, increasing the complexity of compliance management.
  • Time-Consuming Processes: Managing a training matrix manually would require tracking thousands of individual training records, leading to administrative burdens.

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