Go online: http://www.pharmaserialisation.com/Prisym
Call: +44 (0)207 368 9300
Email: enquire@iqpc.co.uk

What are you doing to make sure you have the required documentation?

Benefits of this Webinar:

• Learn what it means to be FDA 21 CFR Part 11 compliant
• Be aware of who needs to comply and what the classifications cover
• Gain awareness of the most common compliance pitfalls and how to avoid them
• Discover how software can aid your business when designing, producing and managing labels
• Understand how costs can be significantly reduced while gaining and maintaining strict compliance global regulations and standards

If the FDA knocked at your door, how confident would you be that your labeling processes comply with 21 CFR Part 11? Do you understand what is required and how these regulations affect you, particularly if your organization is split into multiple locations or if you outsource packaging and distribution? As the FDA cracks down on regulatory compliance it is essential that your label design, approval, management and production processes are secure.

The new challenges presenting themselves to the pharmaceutical manufacturing industry include the creation of unique serialization codes for individual products during the production process, the secure high-speed printing and verification of these codes, plus the subsequent efficient storage and retrieval of any of these millions of codes at any point within the lifecycle of a product and beyond.

Serialization is vital in the fight against counterfeiting. To support this strategy, so is the development of web-based labeling and management solutions that help in delivering secure and compliant printing for mass serialisation and data management to enhance existing production lines or provide a complete turnkey solution. Other benefits of serialization include the ability to track product movement throughout the supply chain to help improve efficiency. The need to comply with evolving regulatory and compliance environments, and build confidence in the efficient storage and retrieval of products throughout their lifecycle will become essential.

For further details please contact the PRISYM ID Life Sciences team

Several attendees commented on the quality of speakers and that the subject range gave them a lot of food for thought. A good deal of information was shared from keynote speakers representing the very best of the industry; particular compliments and mention was made of presentations from Hardeep Gulati and Robert Nientker, both from Oracle, Peter Houston of the specialist publisher, Advanstar Communications and an overall appreciation of the knowledge sharing presentations provided by industry thought leaders from companies such as Novo Nordisk, Pfizer and Novartis.

PRISYM ID’s demonstration was linked live to Oracle in Denver within which. Dave Taylor, PRISYM ID’s Product Manager, spoke about Prisym Medica and responded to the enquiries about Serialisation, 21 CFR Part 11 and Validated label systems in general.

A key contributing success factor of the event was the willingness of attendees to network and share experiences. The ‘buzz’ at the event was tangible and I dare say that the foundations of many new relationships were formed over the intensive two day event.

On a lighter note, PRISYM ID ran a competition in conjunction with Oracle for one of three bottles of Moet Champagne. One of three hundred unique, randomly generated 2-D barcodes could be found in all attendees’ information packs. The code would be scanned and if a match was found in Oracle’s Denver database, a winner was announced. One industrious attendee managed to present five packs to scan, obviously a very passionate Moet collector who unfortunately did not win on this occasion. Amazingly, the first person who did win a bottle was also the first attendee to enter. Congratulations to Kay Wefelnberg of UCB, thank you for participating and we hope you have enjoyed sharing your prize.

For further information and to register please visit: www.oraclelifesciencesforum.com

Why not add a comment or question here about the event, or send a message to us at info@prisymid.com

However, the software validation process can be extremely expensive and time consuming. Many companies employ full-time validation teams who are on a continuous global loop of validating and witnessing every computer system install and upgrade used in the production process – ‘the validation merry-go-round’. Validation establishes by objective evidence that all requirements have been implemented correctly, successfully and are traceable to systems requirements. Remember in the eyes of the regulators, if it’s not documented, then it’s just a rumor.

‘Reducing the Validation Merry-Go-Round – Lowering the time and cost of computer system validation while ensuring FDA compliance’ webinar explored how the validation merry-go-round can be dramatically reduced.

The topics covered include the following and focus around our web-based labeling product Prisym Medica:

• Thick and thin clients for labeling solutions
• How a web-based solution can augment an existing package
• Client and server based printing
• Software version control
• Capturing customer label approvals through web-based software

What are the determining features of a thick and thin client solution for labeling?

The tasks and the nature of their role – if you’ve got a user printing on a high-speed line, would you really want them using a web browser to do that?

Might it be easier to have some kind of front end or thick client which caches information from the ERP systems – if speed becomes an issue on the lines, then it may still be appropriate for a thick client or front end to be the type of solution utilized.

Similarly if you have a very small office and it’s in an area where network connectivity is weak – it may actually be easier to deploy a thick client solution there and have local audit servers just to be able to provide a ‘what happens if the network goes down’ rather than being completely reliant on having to connect out to a web server somewhere outside.

Equally in that scenario you could deploy a local web server and local data source there – but again it’s a question of what is appropriate for a specific situation? A scenario such as high volumes of printing, where an organization has everyone is in one site. That daf be great to use the web technology internally as you’re not reliant on anything outside of your own network.

Equally though, if you’re a highly distributed company, if you’ve got all of your regulatory users in the east coast, technical users on the west coast, maybe designers in Europe then being able to collaborate like this using the web may well make sense for that organization.

Is PRISYM MedicaWeb an augmentation of PRISYM Medica 5 rather than a replacement?

PRISYM Medica 5 will continue to be developed as a front-line solution, a flag ship product from PRISYM ID. We fully expect people to still take full server-client solutions. The way we’ve designed MedicaWeb is to be an alternative way to get into the same logic, business rules, data and formats as you currently can in PRISYM Medica 5.

Companies that have Medica 5 at the moment can deploy MedicaWeb and start the roll out process in a small way by deciding where this is appropriate for them. They’re not replacing their existing architecture – just a web server needing to be added to the network infrastructure and some additional licences ordered.

Some of our current global customers only want it as a web-based solution with no thick clients because they have an IT team based in the US and don’t want them flying all over the world to deal with IQs & PQs every time there’s an software update.

We’ve also got customers that just want thick clients. But for their suppliers and customers they want to extend the system out to them so they can use it. They are not able to install our software in their suppliers or customer sites but MedicaWeb gives them the ability to extend the approval process without requiring a software installation.

Realistically if you can get more people involved with the approval process, there’s less likelihood of errors getting through – improving patient safety.

Does MedicaWeb support both client and server based printing configurations?

The answer is we support both. It’s configured by server permissions as to whether a user can print to a local printer or whether the user can only print to a server printer.

From the server-side you have the ability to set up any number of printers the server can access, but if you’re a client in the UK and your server is based in the US it would make sense for you to print to a printer locally. That local printer doesn’t have to be directly connected to the local machine; it could be on the local network.

In terms of print speeds and quality – currently with PRISYM Medica 5 all of the print jobs get sent from the server to the printer. Now what happens when your client and printer are both in the same location is that you can send the print job from the client to the printer – obviously improving print speed.

How are new software versions rolled out and how tightly are they controlled?

Whether it’s installing a new driver, new functionality, customization which is typically where we get involved in the most, you install it on the server and it can be immediately available to all users. It would make sense that there would be standard operating procedures in place to control this though.

We can configure different user domains so user security can be controlled. If you are in the UK you can login to see the UK experience; if you’re in the US you can login to a different domain and see the US experience.

You also then have your supplier domain and they login and see something different, perhaps even branded differently from your internal sites.

So yes, it can be controlled tightly but the centralized nature of the system is its key strength.

How does MedicaWeb get customer approval on the system?

It’s one of those things we have fundamentally rethought with MedicaWeb. Saving a label as a new version and sending a picture to the customer to get their approval isn’t necessary any more. The customer can now be involved within the software so the customer can be part of the approval process, built in.

The customer can see the label proof you’ve designed in your software – the scenario is the same as if you’ve given your customer a copy of PRISYM Medica 5 and they open up a label as you have designed it on your screen which they can then approve. They can be part of the approval process that says, yes I agree or no I don’t.

Can we integrate with Active Directory for single sign-on purposes?

PRISYM Medica has a real time link to the Active Directory tree so when a new user is created within Active Directory, they’re automatically created within Prisym Medica. The credentials are synchronized and by default the new user is created with zero permission within the application – an administrator then needs to set the individual permissions of a user.

Each domain, be it internal users, suppliers or customers, has its own permissions and method for how it’s synchronized with Active Directory or otherwise.