Regulated Content and Label Management
Specifically designed to meet medical device, clinical trial and pharmaceutical requirements
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REGULATED LABEL MANAGEMENT
The information that accompanies pharmaceutical products and medical devices is essential in ensuring their safe and effective use by patients and healthcare professionals. As such, this critical information is considered an integral part of the product by Regulatory Authorities.
PRISYM 360 delivers unique functionality to manage label content, the design of the content, as well as the processes necessary to request, review, approve and print / output regulated content for use in labels, inserts and packaging.
REGULATED CONTENT MANAGEMENT
For globally marketed pharmaceuticals and medical devices failure to adequately control the many, different combinations and variations of product information will result in regulatory non-compliance and potential product recall. To compound this challenge, there is a growing demand to deliver product information through digital formats and channels, including social media, in addition to traditional physical formats such as leaflets, inserts and data sheets.
At PRISYM ID, our innovative technologies can be used to control this product information as content ‘components’, such as indications, warnings, precautions, symbols, dosage and expiration, whether used in physical labels, inserts and packaging, or as electronic product information in e-labels, e-IFUs (electronic Instructions For Use) or online communications.