Last week’s event and conference provided a great opportunity for those engaged in the manufacturing segment of the pharma industry to come together and share best practice. It was good for us to be there too. The opportunity to listen to what others are saying across the industry keeps us here at Kallik appraised of what’s foremost in the minds of our customers.

It wasn’t surprising that regulatory related topics featured strongly in discussions at what was an interesting and informative event last week. Both the impact of Brexit and Serialisation are clearly hot topics across the industry. Unsurprisingly so, as taken separately they both create major challenges and uncertainties for the industry. Taken together, some might be wondering whether life couldn’t get any harder. With the UK planning to leave the EU two months after the FMD comes into force in February 2019, the whole of the pharma supply chain right from regulatory affairs to contract manufacturing in packaging has some work to do to ensure continued compliance

Two things are for certain however – Brexit will happen and so will the EU FMD. Neither of these is going to go away, so if we’ve not yet started thinking about how to respond, we need to get started very soon. If we leave it much longer, there is a risk that the plethora of point solutions associated with managing regulatory driven content, labelling and artwork creation and packing and print production will increase to the point that it becomes economically unsustainable.

So where does labelling and artwork fit into the big picture here? Well, the first consideration is that having multiple systems and processes hosting labelling content used for regulatory submissions, artwork creation and serialisation data is most likely to be inefficient and prone to error. The second point is that it is very hard to prove compliance when you have to extract and collate information from multiple systems and consolidate this into a single audit report. Thirdly, why choose a discrete physical solution for integrating variable manufacturing data with core labelling content when you can do this up in the cloud electronically?

Here at Kallik, you might have heard us talk about taking a connected approach to artwork and labelling. With Brexit and Serialisation looming on the horizon, embracing both these as an opportunity to create a more open, flexible and sustainable approach promises an easier future for all.

Are you compliant? That’s a question that keeps regulatory affairs executives up at night, particularly in light of increased responsibilities and prosecutions. Where this question becomes even more difficult to answer is with Labelling, since this is an area that traverses so many parts of the enterprise.

Among the factors regulatory affairs must contend with are that very few organizations have complete oversight and most struggle with highly disconnected processes. For example, during the approval process for any Labelling asset, information will likely be sent around the organization in emails or in email attachments. This might consist of a phrase on a label or package, a piece of artwork or a translation required to meet local market regulations. And it’s not easy to trace that information and demonstrate where it originated when it’s managed in such a haphazard way.

Another issue with maintaining oversight is that the vast majority of Labelling activity is driven by required changes. In fact, companies we speak with say changes account for between 75 and 90 percent of their Labelling activities, and most of these changes are regulatory related — because of new legislation or localized symbols or label changes to gain approval for entering a new market. So while the product itself has few or no changes, the Labelling content is constantly being updated and changed.

With so many changes to manage and information coming from multiple stakeholders, it’s difficult to know whether you’re working on the latest approved version, or even if everyone is working from the same version. Changes made locally are often not reflected back upstream, increasing the chances of having multiple uncontrolled versions of the same artwork. It’s a classic problem — how do you know whether you have the latest version? What is the version control process? And who has signed off on the document?

Ensuring Traceability
Compounding this lack of visibility is the demand for greater traceability in light of a heightened focus on patient safety, as well as growing concerns over counterfeiting. If problems arise with products leading to product recalls, such as the breast implant crisis in France a few years ago, being able to trace a product through accurate Labelling is crucial.

If it turns out that you are working on the wrong version and the label that gets onto the market doesn’t have the latest regulatory information or you don’t have proper oversight of that label, you face serious ramifications. For example, your product might be at risk of recall, delayed entry into new markets because of noncompliance with local legislation, wasted time and resources from having to scrap incorrect labels, brand damage, fines, and of course loss of time and loss of revenue.

While you may very well be compliant and your label may meet the various regulatory requirements, the real issue is lack of insight into your Labelling processes. In other words, “you don’t know what you don’t know.”

In my next blog, I’ll explore how you can address these challenges to ensure consistency, oversight and transparency.

Learn more about Labelling by downloading our white paper, “Connecting the Dots Across the Labelling Life Cycle.”

– Labelling content management leader Kallik has produced a new guide on how to plug the gap between ERP and PLM when it comes to packaging, artwork and labelling management workflow

Tamworth, UK March 23, 2015 – Labelling content and artwork management leader Kallik has announced a new whitepaper to help businesses, from consumer goods to closely-regulated industries, become more integrated in their packaging, artwork and labelling management processes.

The paper’s insights, based on dialogues over the course of many years with the Kallik customer base, as well as its network of integration partners, highlights how in some parts of the packaged goods sector, there is a ‘crack’ in the system – a gap left between core ERP and PLM systems when it comes to packaging, artwork, and labelling management workflow.

This is a growing problem, as businesses need to connect the data in the ERP system and the data in the PLM to the artwork management side of the system so as to have a properly unified, single source of truth for all their product information.

And as labelling content  and brand identity become a greater priority – due to a combination of rising customer choice and tightening international compliance strictures – this breach in integrating key processes is becoming less and less tolerable.

One Kallik AMS packaging, artwork and labelling customer, for example, has realised a 40% improvement in turnaround due to saved time and errors by using the Kallik system to bridge that crucial ERP-PLM gap.

The document goes on to explain that a new generation of business software systems offer better performing alternatives to the large monolithic ERP systems of old, with a major breakthrough being more use of Open Source and Agile development techniques, which offer superior connectivity.

The paper also offers practical advice on how to manage an integration project internally, as well as case study-based ROI analysis on how to maximise benefits.

Neil Gleghorn, Chief Executive Officer of Kallik comments, “This resource is good news for business leaders in the regulated and packaged goods industries, who will find it a useful reference tool for making integration go a lot smoother.”

Kallik has a proven track record of working in regulated industries, offering integration solutions that use a data-centric approach to labelling creation and management.

The paper, ‘The Integrated Enterprise,’ is available to download at:

https://www.kallik.com/wp-content/uploads/2015/01/Kallik-Integrated-Enterprise-Whitpaper.pdf

About Kallik

Kallik is a global provider of software solutions that simplify complex artwork management, generation and approval challenges for regulated industries. Kallik’s systems help these organisations to reduce the risk of product recall, guarantee product and brand consistency, mitigate risk and reduce costs. Based on technologies using a structured data-centric approach, Kallik’s solutions leverage and repurpose content to automatically generate artwork, which enables businesses to remove duplication, track content and rapidly change messaging to respond to new market and regulatory challenges.

Formed in 2001, Kallik’s founders and senior management team have a rich heritage in the packaging and labelling industry. The flagship AMS360™ Automated Artwork Management solution was devised based on this insider knowledge of the sector and today underpins the businesses of companies including Sealed Air, Estee Lauder, Coloplast, Integra, Mary Kay and Unilever.

More at www.kallik.com or follow us on Twitter @KallikAMS

 

PR Contact

Carina Birt

PR for Kallik

carina@sarumpr.com

+44 1722 322916

 

Tracey Edwards Quality Assurance Kallik– Seasoned compliance manager Tracey Edwards comes on board to ensure Kallik meets exacting quality assurance metrics –

Tamworth, UK: March 16, 2015 – Labelling content management leader Kallik is delighted to announce the appointment of Tracey Edwards as its new dedicated quality assurance manager.

Tracey will be responsible for extending the British tech SME’s ISO9001:2008 internal quality management system (QMS) and TickIT plus compliance.  As well as leading on-going drivers for compliance with national and international standards and legislation.The new role is also expected to involve close interfacing with external auditors plus ensuring the execution of corrective/preventative action and compliance with service level agreements.

Tracey brings a CV steeped in compliance professionalism to the newly-created position, having extensive experience on both sides of the auditing fence.

Her 25-year plus exposure to pharmaceutical regulations GLP, GCLP, GMP is a major asset for Kallik, including as it does over two decades at AstraZeneca encompassing 12 years of MHRA & FDA audit inspections, as well as a number of years as  a  global quality & compliance manager at with Johnson Controls (JCI)  Integrated Lifescience.

Tracey sees her mission as applying her extensive industry knowledge to take Kallik’s entire quality management approach to a global leadership level.

“Kallik takes compliance very seriously, putting quality solutions and services at the heart of the business,” she said.

“Kallik’s passion for both its solution and customer service is infectious, so I’m looking forward to working closely with the team and will enjoy the challenge of working on all aspects of compliance.

Tracey adds that her ‘mantra’ is Ruskins’ statement that, ‘Quality is never an accident; it is always the result of intelligent effort’ – and that in her new role, “I know no-one at Kallik will disagree.”

Neil Gleghorn, Chief Executive Officer of Kallik added,  “Tracey’s hugely impressive compliance and auditing experience and solid track record in regulatory campaigns at international manufacturing organisations, combined with our own commitment to quality, will meet our customers’ needs and without question help our business overall.”

About Kallik

Kallik is a global provider of software solutions that simplify complex artwork management, generation and approval challenges for regulated industries. Kallik’s systems help these organisations to reduce the risk of product recall, guarantee product and brand consistency, mitigate risk and reduce costs.

Based on technologies using a structured data-centric approach, Kallik’s solutions leverage and repurpose content to automatically generate artwork.  This enables businesses to remove duplication, track content and rapidly change messaging to respond to new market and regulatory challenges.

Formed in 2001, Kallik’s founders and senior management team have a rich heritage in the packaging and labelling industry. The flagship AMS360™ Automated Artwork Management solution was devised based on this insider knowledge of the sector and today underpins the businesses of companies including Sealed Air, Estee Lauder, Coloplast, Integra, Mary Kay and Unilever.

More at www.kallik.com or follow us on Twitter @KallikAMS

PR Contact

Carina Birt

PR for Kallik

carina@sarumconsultancy.co.uk

+44 1722 411150

By Ashley Goldie, Sales & Marketing Director, Kallik

There are two things you need to know about CLPthe European Union’s rolling programme to harmonise the way we tell consumers and users about the contents of the products they are about to buy from us:

One, the ticking of the clock to be all set and ready for this should be getting louder and louder in your ears. Basically, you need to be done and dusted with this stuff by the end of May next year – leaving you eight clear months to be ready.

The second thing you need to know about CLP: it’s not just an artwork change.

It is looking to shape up to be a labelling size change, too – perhaps necessitating up to 30% bigger areas to display all the new stuff you need to.

Which, if you haven’t planned for it, could present you with some nasty surprises and last minute issues come May 31st 2015.

We have been working with customers on CLP for some time at Kallik – but the scale of change people are reporting back to us that is required here is genuinely surprising.

In fact, we are so concerned about the scale of the CLP work which organisations in not just the chemicals area, but in many sectors need to do, that we are running a special educational webinar (click here to register: https://www1.gotomeeting.com/register/296033369)about it next week that we’d encourage you to attend.

We know that many people are aware of this key Classification, Labelling and Packaging EU regulation, which is the way Europe is going to get on the same page of the book as the GHS (Globally Harmonised System), the UN’s internationally-agreed standard way of creating a common global way for organisations to communicate on the potential hazards of chemicals. You are probably equally aware of how CLP complements another key EU regulation, REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals.

In the seminar we are sharing some genuinely new information with anyone involved in compliance around packaging and labelling that’s coming back from the front line: it’s a bigger job than we thought.

Every part of your supply chain

Let’s explain why.

There’s a lot of new stuff that’s coming in. Briefly, these are new classification criteria for hazards, new symbols (pictograms) to show what hazards could be and a set of new risk and safety statements.

So in the first category, think toxicity, skin or eye irritation warnings (as well as many more); in the second, you need to be getting your new red diamond border graphic to contain things like the exclamation mark if your product contains a chemical deemed to be capable of causing harm; and in the latter, you need to not just be changing/adapting the risk statements you may already be using, but also feeding in the new approved precautionary statements which you need to be putting on what you offer the trade or the public. (All of these changes need to be applied to products labels, packaging and safety data sheets.)

Now this is where it starts to get more onerous. One, the EU has lowered the barrier for how big the quantity of chemicals needs to be in a product for it to trigger the need for a CLP update. So, first off, check that products you haven’t had to cover under this don’t now fall under the ruling.

Second, while the large companies in the chemical sector are on top of this, we use chemicals in so many parts of the economy now – not just industry but the consumer space, too – so that if you are in personal care, or in DIY/household, or the medical devices space, or in the cosmetics world, there is a high chance that you offer things to the market that are going to be CLP-impacted.

And, even if you are aware of all this and don’t need to start from scratch, we are genuinely being told by first adopters that CLP means not just new symbology, but new and more words and information needing to be displayed.

That potentially means larger labels –that all have to include the right symbols and phrases.

And they all have to be on the shelves or in your supply chain by 1st June next year.

Let’s work through this in good time

You really do need to start looking at this.

And the sooner the better really is going to save you possible time and money hassles as we move into 2015.

Please – take advantage of the webinar (https://www1.gotomeeting.com/register/296033369) next Tuesday September 23, at 2.00-2.30pm BST, and find out what you do or don’t need to do to meet the CLP challenge!

By Ashley Goldie, Sales and Marketing Director, Kallik.

Today’s blog is all about a brilliant resource on the Web which we think you could get a lot out of.

Swiss pharmaceutical company, Roche has put up a short video on YouTube (called ‘UDI – How a barcode contributes to patient safety’) which explains everything you need to know about Unique Device Identification, or UDI, a regulation that’s been pushed through by the US Federal Food and Drug Administration.

We’ve talked a lot about UDI in these Kallik blogs (e.g. ‘Could Hassles Like UDI Actually Be Blessings In Disguise?’) as we think UDI is a huge challenge for the medical devices sector. That’s because it will have a big and beneficial – if challenging to begin with – effect on patient acceptance with devices from the safety point of view.

I’ve taken a couple of minutes to summarise the video to help work out what the main points are: we hope you find it useful.

“Hi, I’m the new UDI barcode. Soon you’ll be able to find me on all medical devices such as instruments and diagnostic tests.

“Now, you’re probably wondering what that acronym means. UDI stands for unique device identification. In the future, every medical device and diagnostic test across the globe will have to be identified uniquely. This is the result of a new legal regulation that offers a lot of benefits.

“This is how it works: A barcode like me will be present on the packaging of every medical device and diagnostic test. When you scan me, you will immediately get product info like item number, batch number and expiration date.

“I am also able to link you to a global database that contains additional product information. For example, safety information, regulatory status, storage conditions, allergy information and my manufacturer’s contact information.

Entire shipping history

“So the UDI system consists of me, the barcode, and the database where the additional information is stored. You can also use me to track the entire shipping history of the product.

“Come and join me on my journey! My journey through the supply chain begins at Roche, the manufacturer. Here, I am printed onto the medical device or diagnostic tests packaging. At this point, all information about the product is already in the global database. Hidden inside me, there is also a global trade item number – GTIN for short. It comes from a globally uniform range of identifiers that standardises all item numbers so every product of the same model has the same number. This makes the reordering medical devices or diagnostic tests easier, because they can now be uniquely identified by their GTIN number.

“The GTIN also makes my journey super easy to track. Whenever I am scanned somewhere along the supply chain, for example by a shipping agent on my way to the hospital, this info is saved right up to the lab or clinic where the product is currently located.

“The UDI also helps to tackle the issue of product counterfeiting. Patient safety is, of course, top priority and the UDI helps here too. For example, if there is a product issue the devices and diagnostic tests that need to be recalled can be easily identified.”

The video then ends like this: “I help make important information easily accessible, contributing not only to compliance and efficiency, but also to patient safety. I must admit, it all makes me quite proud. UDI – Unique Device Identification.”

I agree! What do you think?

 

Kallik has launched a new resource centre for medical device companies having to deal with changes in regulations.

The medical device sector is used to dealing with legislation and meeting tight compliance demands. Nonetheless, it’s currently facing a perfect storm of compliance changes for which manufacturers need to be prepared.

The US Food and Drug Administration (FDA) has now issued a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act. The Year 1 deadline is24 September 2014 and it is expected that similar regulations will follow in Europe and then the Rest of The World.

Kallik’s customers are already addressing these challenges and are sharing their experiences in The Kallik Medical Device & UDI Compliance Resource Centre. The centre includes case studies, news stories, blogs and webinars – all designed to help those affected by the changes understand and navigate through the UDI compliance maze. Bookmark this page and keep checking back for updates.

By Neil Gleghorn, CEO and Founder of Kallik

For many of the people Kallik works with, these are the most dreaded words in the English language:

Product recall.

And with good reason. Obviously I will not reveal the name, but we have been working with a major North American organisation that had to do just that. Its local regulator requested that it get its labelling in order and fix the issue.

Which it did – or thought it did. It obviously hadn’t, as it had to issue a second product recall a month later. And a third a month after that.

By this point, the regulators weren’t happy at all. They decided they couldn’t trust anything the company was putting out and demanded that every single product got looked at.

An unbelievable 13 product recalls later – with each one costing at least one to two million dollars – and at the cost of hundreds of man-years of effort, the problem was at last solved.

But it nearly killed the company.

Potential for problems

Product recalls can really damage your company’s financial health, as our customer found out. It is in a much, much better position now, after its head of legal got us in to root out labelling problems at source. Only a few months ago in April of this year, US car giant General Motors’ bottom line was severely dented by a $1.3bn charge related to a major product recall, for example.

Meanwhile, in the medical device field, product recalls look set to rise. We are all gearing up for the ability, with UDI to be able to do what General Motors had to do – get back every defective ignition switch. But we’re not there yet – which is potentially very bad news for any woman who’s had a breast implant if their supplier announces something similar; just how are we going to track every one of them down?

UDI will help. But in terms of the wider market, companies are moving to business models that in themselves make labelling more complex. They are expanding their international presences and building new markets – but also reducing manufacturing sites and moving more work off-shore. That means that the number of products and the number of local markets they are looking to serve increase at the same time – a recipe for potential tracking disaster if they don’t get everything right.

What experiences like our customer (and, I’m afraid, far too many others) shows is that getting labelling correct, consistent and easy to change if needed is the absolutely best basis for safe operations.

A range of negatives

I say ‘safe’ deliberately. I don’t want to labour the point, but product recalls deserve the fear they provoke. You’re looking at a range of negative impacts, not just financial short term, but financial long term; you might lose partners, you will alienate parts of the market that may well never come back, you will have to bear the cost of not just collecting the faulty product but disposing of it (safely) and replacing it with (correctly labelled) new items.

Don’t wait until these crises happen. Get on top of this issue as early as you can – look to build an environment that can deal with any of the demands of a regulator, in the way that is most cost-effective for you.

 

 

 

By Neil Gleghorn, CEO and Founder of Kallik.

To conclude our run of case studies of firms that have worked with Kallik to achieve two powerful, inter-related benefits: get up to speed for all things compliance, especially the imminent UDI legislation out of the States and improve labeling processes at the same time to achieve greater internal business efficiencies.

We’ve told you about a great Danish example (‘Using Compliance To Your Advantage – 1: Coloplast’) and a great US example too (‘Using Compliance To Your Advantage – 2: A US Life Sciences Leader’). I want to briefly, please, now turn to another Kallik success story – a German firm that is one of the world’s leading suppliers in casting, bandaging, wound care and compression stockings.

Why? Because this company is yet another manufacturer that’s taken a centralised, automated approach to label artwork management as a way to prep for UDI compliance.

Like the other customers discussed, it’s done that by going for the award-winning Kallik artwork automation solution to streamline the way it manages labelling for more than 14,000 different product lines – many of which have secondary and indeed tertiary packaging requirements.

Previously, the content for individual packaging was treated as its own artwork job – a process that involved the manual collation of input via phone calls and emails from global marketing, packaging development, product development, scientific and regulatory affairs, quality management and external sources. As a result, typically it would take up to 10 go-rounds to get artwork content approved.

The Kallik system saves artwork coordinators having to ‘reinvent the wheel’ each time they need to update content, or create new labelling from scratch. Routine amendments to packaging artwork can now be done without the need to involve an agency or design team. Cycle times are being reduced substantially too – from one to two weeks to prepare simple artwork, to one to two hours. Quite an improvement, I’m sure you will agree!

Meanwhile, compliance with all sorts of requirements – including UDI – is much easier to manage. “What stands out about the Kallik system is its completeness,” this company has told me. “Given the rate at which regulation can change, the level of control provided by Kallik is vital.”

A full toolkit to help you do the same.

A great case study. But what is the real significance of it – and the other two engagements that we have talked about?

As stated, last September the European Commission introduced new measures to restore patient confidence in the medical devices sector in the wake of the PIP breast implants scandal. Among the new codes are clearer labelling (down to individual product level), while manufacturers must be able to prove they have up-to-date procedures that describe all the processes that ensure regulatory compliance. This has been put in, of course, to help us all as consumers – but in practical terms it means manufacturers must first get the internal controls right, and then be able to show the measures they have taken.

Dealing with Brussels and UDI is therefore going to take work. The good news is that Kallik provides a full toolkit as well as comprehensive migration support services to help medical device manufacturers through the entire journey – as you strive to tick regulatory boxes and as you look to achieve a good payback from investment in tightening up your internal processes around content creation and labelling.

To sum up: tempting as it might be to rush down the pure UDI box-ticking route, this is a false economy. UDI is not the only new regulatory requirement on the agenda – which means a point solution just to tide you over will only lead to a lot more duplication and work in the long run, without any real payback.

So why not look at a fresh approach to compliance that involves working from a single approved set of master data that can be reused and repurposed with minimal effort, under strict central controls but with maximal payback?

It is only with this kind of transformation to internal processes that companies can hope to turn UDI and other regulatory requirements to their advantage.

What do you think?