Artwork Management Systems

Transcription

1 Artwork Management Systems How to source the right software for your organisation A buyers guide on how to source the right software for your organisation. by Mark Ennis The Perigord Group

2 1.0 Introduction Right First Time artwork and packaging can be crucial to entry into a new market or indeed the overall commercial success of a drug or pharmaceutical company. It has been well documented that the costs associated with pharmaceutical packaging can represent up to 70% of the cost of the finished product. In addition industry experts estimate that between 35 to 40 percent of all pharmaceutical product recalls are attributed to packaging and labeling errors and omissions. In fact, a recent report by AMR Research revealed that in a six-month period last year, the Food and Drug Administration statistics include 455 product recall notices, 51 percent of which were because of mislabeling, and 13 percent were because of faulty packaging. In terms of artwork and packaging, expanding global markets mean pharmaceutical companies need to deal with localization issues such as language, cultural and regulatory requirements. The scramble for entry into the pharmerging markets, a phrase coined by market intelligence organisation IMS Health to describe emerging pharmaceutical markets, has also offered up some unique challenges. Artwork Management Systems, AMS have a crucial role to play in delivering Right First Time artwork, creating efficiencies and helping to introduce new drugs and establish a foothold in new markets. The question is how do you source software, which will offer a perfect fit for your organisation, your standard operating procedures, your markets, vendors and stakeholders. The purpose of this guide is to help plot a logical path towards choosing the right solution. 2

3 2.0 Defining your requirements Defining your requirements is crucial and probably the most important step in choosing software. We recommend including all stakeholders in your artwork production function during your research. This may sound like pretty fundamental question, however have you clearly defined why you need to source an Artwork Management System? For some organisations the investment required versus the achievable results may not stack up, however for others, sourcing an effective AMS can be a game changer in competing for market share. Case study example A fortune 500 global pharmaceutical company with a diverse and complex portfolio of products had an artwork change request process which typically took 18 days to complete. Perigord Group developed a GLAMS solution, which was configured and installed within the company. As a result the process was reduced from an average of 18 days to 3 days. All paper forms were integrated within GLAMS. The market office kicked off the process and then it instantly moved on to the next task owner. All that Glitters... Features tip - It is understandable that software vendors will communicate and upsell the unique features of their particular software to the very best of their ability. While additional functionality can be very helpful, it s very important for the purchaser to remain focused on sourcing and meeting their core requirements. Saas or Installed? There are multiple considerations when determining the correct platform for a solution. SaaS systems deliver online access which could be crucial in effectively linking multiple offices and vendors. Alternatively do you have the internal capability to manage an installed solution? What level of integration is required with existing system? Quality Systems? What exact requirements will your regulatory department have? Will the software require validation? The requirement for shipping paper forms was eliminated which instantly reduced the process by 4 days. GLAMS utilises alerts and in this configuration all stakeholders received alerts when their tasks were due for completion. In our case study it s clear that the organisations primary goal was to reduce the turnaround time for artwork change requests, thus radically reducing time to market. 3

4 Organisational Goals The most important step in defining your requirements is to document your organisation s overall goals. To do this we recommend working with all stakeholders to develop a list of reasons why you need the software. This list can then be used to help define your organisation s goals. Requirements Once you have defined some primary goals the next step will be to develop a specific list of requirements for the solution. Breaking down your organisation s goals and working with all stakeholders will help you to develop a comprehensive list of requirements. For instance, if the primary goal is to improve collaboration between stakeholders in multiple global locations a SaaS based online solution may be a requirement. The regulatory department may have specific requirements around your approval process, which would necessitate specific features and configurable workflows. There may be specific integration requirements with existing systems. For example, the procurement department may need the ability to issue a purchase order number for each and every job via the system. Example Requirements Workflow - Does the process to be automated by the software application already exist? If so is it documented? Saas or Installed - Will the production team require remote access to your artwork assets and files? File Types - What file types will the solution need to manage? Users - How many internal and external users are likely to use the solution. Integration - Will the solution need to communicate and share information to other systems within the organisation. If so you need to document the exact requirements? Storage - Will the system store your artwork assets and what search capability will you need to retrieve assets. Automatic Artwork - Will there be any automatic artwork capability required? Approvals - Will the AMS need to manage your approval process? 4

5 3.0 Researching options Creating a shortlist of potential vendors is a reasonably straightforward task, all be it time consuming. At the outset it s probably best to develop a comprehensive list of vendors based on their capability to meet your requirements. We recommend using a spreadsheet which will facilitate comparison of features between vendors. Much of this information can be gathered from their web-sites or marketing collateral, alternatively a straight forward Request For Information could be issued. Once developed, applying key industry specific questions will help the short listing task. Key Questions What % of the vendors revenue relates to work within the Pharmaceutical & Health-care industry? Does the vendor have a dedicated Pharma software team What quality and software accreditations does the vendor have and are they compatible with your organisation s requirements. Can the vendor provide references for similar solutions within the pharmaceutical industry? Can the software be validated. Does the vendor supply a validation pack? How complex will the configuration & implementation stages be? 5

6 4.0 Selecting the right solution Software Demos Following all your diligent desk research it s good to get some actual hands on experience and drill down into exactly how a product could fit your requirements. A word of warning at this point, live demos can often be staged by the vendor and therefore it s important to clarify what functionality outlined within a demo environment is available in the current release. Asking the vendor to create a sandbox environment of free trial will enable your team to consider the product in more detail. We would also recommend including stakeholders, end users during this evaluation stage. Developing a simple scoring matrix for each demo will help shield you from being blinded by ground breaking features which will divert attention away from your actual core requirements. References - What do existing customers say? In any request for information ask for references, which are relevant for your organisation. For example, producing software for the pharmaceutical and health-care sector as opposed to the FMCG and Information technology industries is a significantly more disciplined process. The need for compliance, quality standards and validation is of the upmost importance, therefore a reference for an Artwork Management System developed to manage the packaging output of a software firm may not offer a true picture of the vendor s pharma knowledge and experience. The True Cost, Apples for Apples When it comes to choosing software, comparing apples for apples is not always as straightforward as it sounds. Vendors will understand that the cost of a solution is generally the biggest determining factor when purchasing software. Many vendors will offer a lower base licensing costs and then price features as a separate add on. In addition to considering pricing features it s important to seek clarity for costs such as support, training, maintenance and implementation. Don t be afraid to ask in depth questions around the true costs of the system, service levels, implementation etc. 6

7 5.0 About The Perigord Group Founded in 1976, the Perigord Group now provides high quality, cost efficient artwork services to many leading pharmaceutical & health-care companies. Based in Dublin, and with artwork production hubs in Dublin, Connecticut & Singapore and support offices in Sacramento USA, Christchurch New Zealand and Sao Paulo Brazil, the group employs 120 people. Our pharmaceutical and health-care customers now account for in excess of 75% of our annual revenue and our ability to continually deliver Right First Time artwork has been essential to our growth within this sector. We are the only Artwork studio and software development company in Ireland to have attained PS9000:2011 We Understand Pharma Producing artwork for the pharmaceutical and health-care sector as opposed to the FMCG and Information technology industries is a significantly more disciplined process. The need for compliance, quality standards and validation is of the upmost importance. Over the last decade, the Perigord Group have invested heavily in the development of Pharma technology, training, consultancy and process knowledge. 7

8 The Perigord Group