Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation. Over time the traditional validation activities have become centered on documentation, which has increased tremendously and led to additional quality issues.
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Until recently, the FDA has remained silent on the issue of adapting electronic systems to manage the validation process.