Regulated Labeling

THE CHALLENGE OF LABELING WITHIN THE REGULATED LIFESCIENCES AND MEDICAL DEVICE INDUSTRIES

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.

Unlike general, non-regulated production labeling, this product information comprises a significant array of content, including indications for use, warnings, precautions, symbols, dosage, and expiration, in addition to manufacturing batch/lot data and serial numbers.

Each of these components of label content are critical, as any errors or omissions will directly impact efficacy and patient safety.
Which is why medical device and pharmaceutical labeling is highly regulated; both the label content, and the processes and systems used to design, print and check their accuracy.

The challenge for pharmaceutical and medical device manufacturers is these content components are not easily stored within ERP, enterprise labeling or document management systems, or if they are, they are often unmanageable and uncontrolled, necessitating manual processes.

HOW WE HELP WITH REGULATED LABELING

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.

These features encapsulate the industry best practices we have learned from our 15 years of clinical research and medical device labeling implementations, so new users can capitalize on the experience of their peers, to maximize efficiency and compliance.
Unlike enterprise labeling platforms, PRISYM 360 has inherent support for electronic records, electronic signatures and audit logging, simplifying FDA 21CFR part 11-compliance.

We provide PRISYM 360 as a SaaS platform, removing the complexities of the technical architecture’s design, support and validation, and enabling rapid service implementation and expansion. This is particularly relevant as pharmaceutical and medical device companies increasingly try to reduce their Time to Value from technology investments.

At PRISYM ID, we use GAMP guidelines in the design, implementation, and support of our products, because we know our customers must also, and this aids them significantly in validating their computerized systems are fit for intended use, efficiently and effectively.

PRISYM 360’s unique content features and best practices are essential in the design, approval and print/output of the highly regulated content required in pharmaceutical and medical device labeling and packaging in an efficient, compliant and low risk manner.

Our Offerings

MEDICAL DEVICE LABELING

Med Device Labeling - Regulated Labeling

Medical device manufacture represents one of the most demanding of labeling operations of any industry. As both product specifications and country-specific regulations change, assuring on-going label quality and compliance represents a clear operational risk.

PRISYM ID’s innovative content management features for creating, changing and printing medical device labels and IFUs provide the continued assurance of label quality and compliance.

CLINICAL TRIAL SUPPLIES LABELING

Clinical Trial Labeling - Regulated Labeling

Clinical trial supply labeling, performed either in-house or through CROs/CSO, is highly challenging; the complexity of Investigational Medicinal Product (IMP) and study protocol data, coupled with the extensive regulatory and language labeling requirements, create a content control challenge that ERP systems are unable to meet.

PRISYM ID’s unique clinical trial labeling content features and best practice provides certainty that clinical labels and booklets are produced accurately, efficiently, and compliantly, to support today’s complex, adaptive clinical studies.