How does the proposed solution work within the scope of 21 CFR Part 11 and/or Annex 11?
Any electronic Quality Management System (eQMS) that is marketed for the Pharmaceutical industry will have built-in functionality to meet the requirements needed for compliance. However, if the solution is not designed for pharmaceutical companies, the question of compliance should be raised early in the selection process. An evaluation must be completed to ensure a compliant approach will be achievable and to determine whether it is sensible within the cost and time constraints of the planned implementation project.
If the Quality Management Systems that you’re considering are scoped for pharmaceutical industry, be sure to think about the validation cycles required for hosted or SaaS model solutions. Will your users be available for testing? Will the business be accepting of outages and down time to support regular deployments of new configurations? Who will be responsible to analyze and accept the defined risk for upcoming changes?
For any eQMS implemented for your business, the question of upgrades will regularly arise. Those solutions on the hybrid cloud or SaaS model will prompt a more urgent response to the question of validation as there are vendor release cycles to observe. The business will need a dynamic, responsive risk-based analysis and assessment of changes and quick turnaround of the validation/verification actions to maintain the validated status of the system. This is certainly not an impossible task as so many businesses use SaaS solutions, but it is an important area to evaluate and plan for when deciding which solution to choose.
What information and data does the business need the eQMS to manage? The various solutions offered can accommodate some, or all, Quality Management areas for the business. In most cases, the business can decide the extent of those areas that will be managed within the eQMS. Consider whether all existing Quality solutions should be incorporated into a single solution, or if the new system should start small and expand to other areas over time. Look to identify the processes with the largest pains in place currently; a clue for identifying those processes is to look for the overall time it takes for the records to close. Industry standards for Change Control, Deviation, and Audits will provide a benchmark for how well you are keeping to the schedule. If these quality management actions are regularly falling outside of these benchmarks, it could signal that the process needs some improvements, and those improvements can often be realized by implementing an electronic system for managing the events.
The ability to manage supplier quality is also something that many of the solutions offer. Either through an oversight process or by allowing the supplier to log on to your solution to create quality-related records – this functionality can help to alleviate some time-consuming processes in the business working with suppliers.
Another scope related question is that of the platform’s ability to support business areas that fall outside of the immediate quality-related focus. For example, Supplier Audits can often signal the health of the relationship with that supplier. Regularly failing a supplier during an audit can alert the contracting department, prompting updates to existing contracts or even termination of a contract, or suggesting qualification of an alternate supplier. Similarly, managing status changes for releasing batches of products can be automated to ensure that unreleased products or products requiring investigations remain on hold status.
Identify the departments and sites that will be involved in the process to implement, and most of all, in the use the future eQMS. The application might only apply to some sites depending on the actions taken at those sites, so it is better to avoid opening up too many new topics while you are just starting out. Also be sure to include stakeholders from the beginning so that they won’t be surprised with the finished product. Last minute updates to their processes or their migration activities can be a disaster.
What is the approach for transferring existing eQMS data and information? Consider that once you select an eQMS and are ready to start the implementation process – the ability to bring your existing data and records into the new system might be another decision point. There is always a way to accomplish this type of migration, it is a question of whether or not there is sufficient value after go-live. Some considerations include whether the system can easily accommodate existing records: is there enough metadata to support the base requirements in the future eQMS or will additional enrichment or system configuration changes be necessary to support importing this information?
In the event a new site is added to your company, how will the eQMS adapt to new processes, users, and data? Implementing a system to meet known requirements can be attainable, however if the system is not scalable or flexible to accommodate future business, you might end up in a place where you will need to select a new eQMS and repeat the process once again.
Also, what happens when you add a new product to or divest a product from your portfolio? Will it be straightforward to update the eQMS? Or will you need to allocate time and material to the efforts? How will this change affect the validated status of your eQMS? Just to list a few of the considerations.
4. Maintenance/Upgrade paths
When implementing any software solution, it is important to assign and spread responsibilities to make sure that none of your team members will be overloaded. Consider where the responsibility would lie for the software maintenance. Who will solve infrastructure issues? Who will maintain user access and group membership? Who will plan and implement the upgrades? What impact will upgrades and maintenance have on the business? What effect will the upgrades have on your end users? Who will train the users on new functionality? Who will decide which functionality to turn on or validate?
Last but not least, of course one of the top considerations for your financial team will be the cost of the solution. Even in this area there are multiple options to consider, the most obvious difference is a one-time license (with annual support engagement costs) versus a subscription model. Both models have benefits and drawbacks, so consider the following questions when evaluating:
- One-time License payment
– Are the user counts consistent?
– Does the business have resources available to support the infrastructure?
– Will the business users be satisfied with a less agile solution and patient for upgrades/improvements
- Subscription model:
– Will the validation resources be available to maintain the validated system status?
– Does the business prefer a more dynamic solution with new features released regularly?
– Does the business support training users on new functionality with the software releases?
There are quite a few factors to consider when selecting the most fitting eQMS for your business. Evaluating the benefits, risks, and on-going maintenance requirements for the available solutions is not an easy task. But defining the different considerations and evaluating the options available against a uniform set of criteria, can help your team to select the best fitted solution to enable your business to manage patient safety and product quality with a successful outcome all around.
About the author
Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.