In a recent survey, 43% of responders were not confident or were unsure as to whether their current labeling solution would do everything required beyond 2015. With regulations such as 21 CFR Part 11 to comply to and others coming to fruition including FDA UDI, medical device manufacturers whether large or small need to be change.
74% of manufacturers stated that the key driver to make changes to their labeling process was ensuring regulatory compliance, yet 62% would find it difficult to assess the impact of making changes to their system. Time-lining when and how to make essential changes to stay compliant with regulations while keeping the production line rolling is a tough balancing act, but it can be much easier if you have expert advice and support on hand.
The need to meet specific labeling regulations with complete label lifecycle traceability of every product is increasing. PRISYM ID recognizes the need of providing not only the right software but as importantly the right professional services team that has a full understanding of the unique constraints of labeling compliance; guiding you through implementing, advising on adhering to regulations, and how to document that your organization is compliant.
Change management in labeling compliance has become simpler, giving you the confidence to have an open door policy with the FDA.