HOW TO ACHIEVE SIMPLE,

AFFORDABLE ENTERPRISE

TRACEABILITY IN THE CLOUD

The FDA and other government entities

are instituting traceability regulations for

pharmaceuticals and medical devices.

Supply chain constituents will need to be

able to trace chains of custody from the

pharmacy back to the manufacturer.

Emerging regulatory requirements in

global markets will include:

Unit-level serialization.

Point of sale verification.

Central government reporting.

Manufacturer-to-pharmacy traceability.

But rigid point solutions to meet these

requirements become costly and

unmanageable over time.

Why?

Because new requirements always

emerge and change.

So these supply chain constituents need

a DSCSA-ready, GS1-certified

serialization solution.

One that centrally manages regulatory

requirements.

One that reduces the cost and

complexity of compliance with

traceability laws.

One that meets the needs of their

organization.

Whether they have 1 million, 50 million,

or 100 million serialized items.

Whether they do business with a

handful, dozens, or hundreds of

partners.

They need to deploy a global traceability

and compliance solution via a private

cloud.

They need to eliminate the overhead

required to expand their current

infrastructure.

They need to leverage the economies of

scale inherent in cloud computing.

They need to expect 21 CFR Part 11

compliance, the FDA requirement for

data integrity and digital signatures…

…which assures better data security

and mature product offerings that

support good manufacturing practice.

And they need to maintain the highest

levels of security, reliability and

scalability in a single-tenant

environment.

With a global traceability and

compliance solution running in a private

cloud, they can:

Reduce costs.

Speed implementation and focus on

their core competencies.

Improve reliability and performance.

Take advantage of flexible processing,

storage, and deployment capabilities.

Easily expand their trading community.

Get immediate access to innovation, like

the latest features, patches, and

upgrades.

And there’s no need for high-cost

consultants or extensive IT resources.

Organizations can choose subscription-

based pricing to leverage the vendor’s

staff and infrastructure.

The software is already up and running,

so they can deploy it in their enterprise

immediately.

Customer design and data flows

leverage the vendor’s best practices and

management expertise.

And if their needs change, they can

switch to an on-premise model for closer

integration with other enterprise apps.

Or create a hybrid solution that perfectly

suits their business and technical

requirements.

To all supply chain constituents, the

message is clear: The time is now!

The FDA and other government entities

can introduce all the new requirements

they deem necessary.

And you’ll always be ready.

Click here to learn more now.