UDI aims to reduce medical errors involving medical devices by:

• Providing a single, globally-accepted source for positive identification of medical devices
• Ensuring the adequate identification of the device through its distribution and use
• Providing rapid access to key attributes relating to the device
• Simplifying integration of information on device use into medical records
• Providing a means of added depth to patient and physician educational materials without adding greater complexity

UDI also aims to provide for more rapid resolution of device problems by:

• Making it possible to more rapidly identify devices involved in adverse events
• Providing for more rapid resolution of confirmed problems
• Provide a single, globally-accepted “key” that can be used to link and integrate existing government, hospital, and corporate data bases that relate to medial devices
• Meet other Federal agencies’ needs for a single, consistent means of identifying medical devices
• Reduce the costs of moving medical devices in international commerce

WHO IS IT RELEVANT TO?

UDI is relevant to any organisation working in or supplying medical device products to the US. Where can I find out more about UDI? Visit www.fda.gov for more information.

Prisym Medica Labeling Software:

PRISYM Medica labelling software is a purpose designed labelling solution for Life Science organisations that need to meet the FDA’s labelling regulations. Medical device companies can easily implement UDI utilising the PRISYM Medica Solution. PRISYM Medica is supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

First, you can’t afford to be random about random numbers. While it is not difficult to create a few thousand different numbers, the reality is that even in a particular batch you could need a hundred times that. Across multiple product lines and over a period of years it could amount to many million. Any solution must be scalable and sustainable.

The very nature of randomization means that numbers can be unintentionally repeated which would seriously compromise the reliability of your system and potentially endanger patient safety. Generating and managing unique numbers requires a highly robust and validated solution.

It is further complicated by the fact that you could have a serial number for one product that is the same for another product. This raises the most fundamental issue surrounding serialization. How you manage and administer number generating and allocation and what’s the best approach to keeping it both logical and simple?

Want to know more? why not download the entire white paper from PrisymID , also leave a comment below add your insight and your experience in this area, we love to hear from you….

• National Reporting and Learning Service
• National Clinical Assessment Service
• National Research Ethics Service

THE NATIONAL REPORTING AND LEARNING SERVICE (NRLS)

Aims to identify and reduce risks to patients receiving NHS care and leads on national initiatives to improve patient safety.

Through its national reporting system, the NRLS collects confidential reports of patient safety incidents from healthcare staff across England and Wales. Clinicians and safety experts help analyse these reports to identify common risks and opportunities to improve patient safety.

Feedback and guidance are provided to healthcare organisations to improve patient safety. These include alerts to address specific safety risks, tools to build a strong safety culture and national initiatives in specific areas such as hand hygiene, design, nutrition and cleaning.

The NRLS works closely with royal colleges, frontline staff and organisations, patient groups, strategic health authorities, other NHS bodies, academic centres and sectors beyond healthcare to promote patient safety.

Through its funding and monitoring of the three independent National Confidential Enquiries (patient outcome and death, maternal and child health, and suicide and homicide by people with mental illness), the NRLS can maximise the benefits of their in-depth research to better improve patient care.

THE NATIONAL CLINICAL ASSESSMENT SERVICE (NCAS)Supports the resolution of concerns about the performance of individual clinical practitioners to help ensure their practice is safe and valued.

NCAS does this through two closely collaborating aspects of its service. Its case management service gives expert advice and support to local healthcare organisations and their staff. Where necessary, this is amplified with specialist assessment of performance and support of local action planning to restore and assure safe practice.

NCAS also works with healthcare organisations to share its experience, with the aim of helping healthcare services deal effectively with performance concerns. This is done through the publication of themes, trends and results emerging from its work, and educational events.

NCAS currently provides a service to healthcare organisations throughout the UK and its associated island administrations, crossing both public and private sectors covering doctors and dentists and pharmacists.

THE NATIONAL RESEARCH ETHICS SERVICE (NRES)

Protects the rights, safety, dignity and well-being of research participants that are part of clinical trials and other research within the NHS. It also facilitates and promotes ethical research.

NRES protects research participants by maintaining a UK-wide system of ethical review via NHS Research Ethics Committees (RECs).

RECs review research applications and give an ethical opinion regarding their proposed participant involvement. Applicants include: pharmaceutical and medical device companies; healthcare professionals in the NHS; academic researchers including students; and prison health researchers.

RECs are entirely independent of research funders and hosts. This enables them to put participants at the centre of their decision making.

NRES has undertaken various initiatives to progress ethical research in the UK and always looks to build researcher and public confidence in the review service.

WHO IS IT RELEVANT TO?

The NPSA is relevant to any organisation supplying products or working in the UK healthcare market. To find more information visit http://www.npsa.nhs.uk/

Prisym Pharmacy Labeling Software:

PRISYM Pharmacy software is a purpose designed labelling solution for healthcare organisations, specifically developed to help you meet current compliance requirements including MHRA, NPSA and CLP. PRISYM Pharmacy is supplied with life-cycle documentation based on the GAMP V Model.

PRISYM Pharmacy allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging as well as data integrity.

What is pharmaceutical Serialization labeling?

Many different solutions are being trialled across the world, all focused on reducing the impact of fraud within the pharmaceutical industry. Most involve the application of a unique random identifier that can be verified at – various parts of the supply chain – point of issue to the end user.

Systems need to allow these unique numbers to be coded to the appropriate standard (GS1, RFID, DataMatrix) and then to be applied to the product quickly and efficiently, using existing technology where appropriate.

Label Printing

During production, when label printing or marking directly onto products, all print actions need to be automatically recorded including details such as who, what (batch, lot, GTIN and serialisation code), when and why are all written to a secure location on the server.

The security of both the client and the server is ensured by a combination of the operating system and application software. The security is well proven and documented as part of the system validation support services.

How Prisym ID can help?

Prisym Medica allows these unique random identifier numbers to be coded to the appropriate standard (GS1, RFID, DataMatrix) and then to be applied to the product quickly and efficiently, using existing technology where appropriate.

PRISYM Medica is specifically developed to meet the FDA’s current requirements and is fully supported by our own software life-cycle documentation based on the GAMP ‘V’ Model.

Working with Oracle Pedigree and serialization labeling Manager which can provide very high volumes of unique, secured and ‘intelligent’ serial numbers, Prisym Medica for Oracle can ensure that your business can meet the requirements for serialized products now and in the future.

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.

PRISYM ID and Oracle have joined hands to present a free webinar on Wednesday, May 12, 2010 addressing this very issue. Register today and also receive a free serialization whitepaper! “When serialization could be your answer to global anti-counterfeiting”

……… you can’t afford to miss this session!

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 those of you who are interested, the Oracle Life Sciences Forum will also be held in Princeton, NJ, USA on 7-8th April. 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 at prisymid dot com?

Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

PRISYM Medica enables you to:

• Implement one complete solution to fulfil the labelling process within your organization
• Meet the FDA and MHRA compliance requirements
• Realize GMP compliance by meeting the GMP’s guidelines
• Ensure complete history is maintained though the system by automatic revision and version control
• Build a three stage approval mechanism, reducing the opportunity for error to be present on label used in production
• Reduce duplication and easier to manage label designs with data driven printing
• Design labels for global use due to Unicode compliance
• Produce over 35 types of bar codes including GS1 DataBar, ITF14, EAN, DataMatrix, Code 39, Code 93 and QR codes

In addition, our thin client PRISYM Medica Web offers you:

• An Internet Explorer based solution which is quick to deploy and can be used ‘outside’ the organization for selected partners
• The ability for less validation effort than traditional thick client solutions, enabling faster rollout
• A proactive review and approval work engine which increases the accuracy of layout and data used on labels reducing the likelihood of product recalls

When designing and producing prescription labels, there are key elements which must be considered.

• MHRA compliance – For any prescription label, the correct information is vital to ensure patient wellbeing. Required information includes prescribed dose, route and frequency to be administered as well possible classification symbols/ pictograms, language requirements and supplemental information.
• Secure production – With prescription labels, accuracy is crucial. The healthcare professional administering the medication is accountable for their actions. If this role is delegated, the primary professional is responsible for all aspects of the administration, therefore controlling label production with individual user rights is essential to enable complete confidence during and post production.
• Ability to reprint and reconcile – Reprinting of printed labels needs to be quick and easy, however the reconciliation is fundamental. The ability to be able to track any reprints required for prescription labeling in an audit log against the original record is vital.

Why Patient Specific Direction?

One of the ways to combat these issues is via Patient Specific Direction (PSD). PSD is a written instruction for medicines to be supplied and/ or administered to a named patient. The prescription need to be instructed by a qualified and registered prescriber and include prescribed dose, route and frequency to be supplied or administered to a named patient. These can be instructions written in the patient’s notes, or a note sent to a treatment room for the administration of a medicine or a course of medicine. The treatment and administration should be documented and auditable.

The Solution – Painless Patient Specific Directions Labeling
To help support healthcare organizations, PRISYM ID has developed an off-the-shelf, ready labeling solution.

PRISYM Pharmacy allows you to design, review, approve, print, reprint and reconcile your labels and has purpose built user security, group security and secure audit logging as well as data integrity. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

For more information on how we can support you, please contact us.

Why is it Important?

GMP compliance enforces global quality guidelines for pharmaceutical and medical device manufacturers to follow. The development of automated processes has led to GAMP (Good Automated Manufacturing Practice) which provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It offers guidance on:

• Adhering to processes that will satisfy the regulatory requirements
• A scalable approach to GxP compliance through the complete lifecycle
• Driving towards a risk based approach
• Effective supplier relationships
• Use of existing documentation and knowledge
• Continuous improvement within QMS
• Quality by design
• Effective governance to achieve and maintain GxP compliance
• Helping bring down the cost of compliance

GMP compliant systems are within any organisation manufacturing and testing with pharmaceuticals and medical devices.  To find out more about the GMP standards and what is GMP ? Visit www.ispe.org for more information.

PRISYM ID has developed PRISYM Medica, PRISYM Pharmacy and PRISYM ClinTrial labelling software as purpose design labelling solutions for Life Science organisations and are supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

PRISYM software allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

To find out how Prisym ID Software can help you achieve your GMP compliance requirements leave a comment on this post or contact us … we love to hear from you …

PRISYM Pharmacy allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging as well as data integrity. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

PRISYM Pharmacy’s benefits include:

• Implementing one complete solution to fulfil the labeling process within your organization
• Meeting the MHRA compliance requirements
• Realising GMP compliance by meeting the GMP’s guidelines
• Ensuring complete history is maintained though the system by automatic revision and version control
• Reduce duplication and easier to manage label designs with data driven printing
• European symbol/ Global pictogram library for Classification, Labeling and Packing or Substances and Mixtures (CLP).
• Multi-language risk phrase/ hazard statement and safety phrase/ precautionary statement