Quality & Compliance
Safety & Vigilance
09 january 2023
Whether it is your first time selecting a publishing tool or you are looking to replace your existing one there are certain factors to consider before making the choice. First establish a list of what you are looking for in a tool. Every organisation has different requirements, depending on size, global presence, and the number of products they wish to market, and it is important your choice of tool reflects this.
The pharmaceutical industry is highly regulated, so the first thing to consider in the selection of a tool is its adherence to all regional regulations; all tools must be validated and recognized by each authority. Fifteen years ago, there were only a handful of tools to select from that met diverse regulatory criteria, however, today there are a plethora of suitable tools, with new options developed each year, making the selection decision increasingly challenging.
Most pharmaceutical companies have a global footprint and thus the tool selected must support the needs of all markets. For companies currently focused on specific local markets, it is important to consider if this will be their intent for the future; the choice of tool must be future proof and enable a company to move into different regions without the need to change publishing tools. Any switching of publishing tool brings a financial burden because of the time, money and resources needed to invest in the project. So, if you are choosing a tool for the first time it makes sense to consider the company’s future regional footprint to avoid any need to switch tools later.
What does it mean to have global footprint in selecting the correct tool? The answer to this question is straightforward, in that the tool should support submission to several different regions. It is critical to keep in mind that not all regions accept eCTD and thus it is essential the tool supports eCTD as well as ACTD, EAEU eCTD, NeeS and Paper. Within the eCTD category the tool needs to support the different regions and have specific templates as per regional requirements. Once you have shortlisted publishing tools that enable global presence, the next step is to understand the tools capability for transitioning across regions; it is important the tool has cloning features.
On shortlisting suitable publishing tools, it is essential you consider the tools’ compatibility with established company software. Interoperability is a particularly important aspect in selecting the right tool for your organization. Any publishing tool must easily integrate with other tools, including electronic Document Management Systems (eDMS), Regulatory Information Management (RIM), Storage and Submission Content Plan Systems. All publishing tools should facilitate seamless integration in a secured manner. If this a showstopper for you, do consider a end to end RIM suitesand select a provider that offers all the tools required as a bundle; this gives you the reassurance that integration is well covered.
Another aspect to consider in your choice of tool is flexibility. It is imperative to know and see how flexible the tool is, be it in its deployment, or during use. So, what aspects make a tool flexible? Tools available in cloud-based or on-premises models is one example of flexibility. Don’t forget that once installed there are strict validation requirements and depending on the tool selected you might have to be responsible for the validation in house. User interface flexibility is another aspect and do consider if an out of the box option is a suitable option. Alternatively, you will need to collaborate with the vendor to ensure they address all your needs in advance before moving further in the process. Another showstopper in this category is having the ability to review, comment and approve the published dossier within the tool. This functions differently depending on the tool, an example being a separate reviewing tool independent of the publishing one or an all-in-one option with the access being the limiting denominator. Since publishing can sometimes be fully or partially be performed by an external subcontractor, the tool preferably needs to be available remotely for ease of access and limit the need to export and reimport dossiers. For those looking for an alternative to their existing publishing tool, do consider the ease and flexibility of migrating existing data whilst maintaining validity. Technology allows you to save time and improves quality/accuracy through simple user interfaces. Do not settle for anything less.
Vendor knowledge, expertise and support is also a crucial factor. The person assisting with the deployment and integration needs to make the process seamless. They need to guide and support you throughout the entire process. Once the tool is deployed and integrated the vendor must provide around the clock support in the event of problems. Do ensure the contract is well defined in terms of support, training, on-boarding and financial commitment (no one wants to pay extra after the fact due to not considering hidden costs).
Partnering with the correct vendor can make the difference between success and failure, between efficiency and inefficiency. But recognising that finding the right partner is a time-consuming task, it makes sense to ask the help of a resourceful, expert consultant. Assisting companies with publishing tool selection and implementation is one of the services offered at ProductLife-Group (PLG). We can be involved across the entire process or only support specific parts. Our comprehensive, robust checklists help us identify the right vendor/tool for you and your organisation. We assist with configuration, implementation, and migration phases as well as supporting training. Finally, we provide crucial support with the writeup of user guides, SOPs and work instructions, and we provide engaging video trainings when needed.
If you are wondering where to start with choosing a publishing tool, talk to us and let us help you make the right decision. Also, if you wish to find out more about the services that we offer click here.
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