Updated: Aug 18, 2019
Selecting a compliance management software, be it Quality Management System, Regulatory Affairs Management system, Training Management system, or Document Management system, is a crucial decision to the organisation, and can have tremendous impact on its ability to release products to the market while minimising the risk of noncompliance. Here are the aspects one must consider before selecting his weapon of choice.
First and foremost, your system of choice must comply with all the relevant regulatory requirements such as the FDA’s rule on Electronic Records/Signatures (21 CFR Part 11 aka Part 11) and the EMA Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems (aka EU Annex 11).
In general, these protocols define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It defines criteria for the use of e-signatures, the tracking of entire record and system history (i.e. Audit Trail), and forbid the deletion of data.
Most software vendors operating in the life science industry provide these capabilities, however process implementation must be done in a certain manner in order to adhere to these regulations. More on that below.
2. Business Requirements
It is highly recommended to understand the business processes you’re trying to digitize and define the key pain points in the way they are handled today.
When evaluating your future system, it is recommended to evaluate two main aspects; How well does the system meets the needs of a specific quality area, and the coverage of solutions the system provides to a variety of business processes.
Most software solutions nowadays are “loaded” with out of the box quality areas, and if needed can usually be customized to meet the specific needs of your business. However, the most advanced software can automate critical business steps such as proper document management, training management, and the automated correspondence with parties outside the organization, thus saving significant time and costs.
Moreover, it is highly recommended to look for a system which can handle as many processes and answer as many businesses needs as possible. Why? Well the first and obvious reason is to reduce costs; the more people and services you can provide using a single system, the less you need to spend on purchasing and maintaining multiple systems. However, there’s another reason just as important; choosing a wholistic solution will enable tracking of full processes from start to finish, thus providing a complete view of the issue. For example, it is quite common that a customer complaint turns into a CAPA which requires both the reporting of the issue to the relevant regulatory authority as well as an update to an SOP, which in turn requires the retraining of the team members to which this SOP applies. To some companies, the process I’ve just described can involve as many as 5 systems (CRM, QMS, RA, Doc Management, and Training Management) and therefore makes it almost impossible to have an overview of the entire issue. However, there are systems which can handle the entire process described above, thus fully accommodating the company’s procedures.
It is no secret that most compliance management systems are not very user friendly. Technology trends and solutions that have long been part of our everyday lives are simply absent from most of the solutions out there. It is something we take for granted from Facebook, Google, and other daily applications but have learned to live without it in the compliance management world.
There are several reasons for it, the first being the “Record” as the core building block of most systems out there. Records are the single instance of a process and follow its defined steps and enforced rules, and today’s systems have perfected the ability to define these steps and rules. However, this doesn’t say much about the usability of the system, and about how easy and intuitive it is to capture data and navigate within the system.
Another reason for the lack of innovation in the usability aspects of the compliance management software world is the common “consulting” business model, in which companies require significant human effort (paid by the hour) in order to implement the system and customize it for the customer’s needs. Therefore, many pain points of the customer and many of his needs are being met by “work arounds” done in the field by solution experts, rather than communicated back to the product team for enhancing the system and servicing all of the company’s customers (and if you think about it, companies have little interest in developing significant enhancements which might reduce their consulting revenues).
Regardless of the reason for the lacking usability of common products, a good compliance management system places the user in the center and focuses on making her daily work and her collaboration with other team members easier and smoother, including tools such as tasks and reminders to enhance her productivity, social tools such as chats, forums and polls to help her collaborate with other stakeholders in and outside of the organization, and even AI and data mining to help her finish her work sooner and at better quality. For a good compliance management system, the tracking of the “Record” and the enforcing of business rules are just the byproduct of productive user and good team work.
4. Decision Supporting
While productivity and collaboration are important for day to day activities, it is crucial to select a system which can harness the power of data that is gathered during daily business operations, and use it to support strategic, forward looking business decisions.
While all systems enable basic analytics, in most cases they require significant technological knowledge (and therefore significant consulting services) to generate meaningful business insights at the proper period in time when it is needed the most. However, a good compliance management system enables easy to use, drag and drop reporting capabilities no different than running them on an Excel spreadsheet.
Moreover, the system should suggest next steps and provide push business insights by employing advanced machine learning algorithms which use the power of the data collected to improve future performance.
5. Agility and Maintenance
Translating a business process into an electronic system is easy, and usually represent a fraction of the effort needed to implement and maintain the system. The total cost of owning a system includes its design, implementation, validation, documentation, as well as ongoing maintenance.
While systems from past generations were installed on-premise and required significant support in license management, load balancing, security, and general infrastructure costs, today’s systems are provided as cloud software which reduces significant costs and effort.
Nonetheless, today’s systems are still heavy on human effort (and therefore consulting services) when it comes to documenting system configuration as well as validating it, and therefore make implementing a new process or updating an existing one a very tiring exercise.
Companies will forever be in constant change, be it due to organizational reshuffles, regulatory update, entering new markets, expansion (organic or M&A), or simply implementing lessons learned. However, due to the complex implementation method and the heavy effort it requires, companies usually experience a lag between their ever-changing business needs to current system configuration.
Therefore, when selecting a compliance management system, one must look for a pure SaaS solution which enables agile process implementation and continuous system improvement by applying a risk-based approach and by utilizing automated tools to replace human effort where possible.
It is no secret that the highly-regulated industry of compliance management systems has been underserved by technology and traditionally provided poor User Experience and decision supporting tools but at the same time required significant human effort to implement and maintain them.
When selecting a compliance management system, one must select a system which provides the best process solution and user interface, covers the full range of the processes required, and enables agile implementation and maintenance, so that your team can focus on delivering better products saving more lives.
Author: Or Tzook, CRO @ Simploud.com