Effective quality leaders know that securing executive support and buy-in are key factors in successfully selecting and implementing an eQMS. Convincing skeptical C-suite colleagues of the strategic implications and costs of the current state can be challenging, especially in documenting both hard costs and intangible benefits/risks. It is necessary to speak in terms that they understand and appreciate, starting with Return on Investment (ROI).
Efficiency will undoubtedly be the most immediate and pervasive benefit of implementing an eQMS but the case can be made that the potential for ROI extends far beyond a cost savings. Below are five areas where quality leaders have reported business impact after implementing an eQMS.
Manual quality management systems are a drain on time and resources for the quality team as well as every employee involved in the various critical quality activities that the QMS supports, such as the development and approval of a document or assignment/management of training. Quality leaders have cited an average of 10 total hours required to implement just a single new document in their business due to the multiple meetings and physical ‘chasing’ for reviews and required signatures.
Automation via an eQMS system has been proven to reduce the number of hours required to implement a new document or training by more than 50% on average, a number that grows with complexity, size and geographic dispersion. A workflow that is managed digitally enables employees to sign off on new documents/ trainings from any location in the world. And collaboration on the review of the content can be managed in the software as well- reducing the number of physical meetings that would normally be required in a manual environment.
Faster time-to-market for new products and services
In today’s marketplace, compliance can be viewed as a competitive advantage for life science companies that want to navigate the regulatory process with reduced risk and fewer setbacks. Implementing an eQMS enables companies to proactively identify and mitigate potential compliance issues before regulators take formal action, reducing the chance of extensive delays resulting from investigations and failed audits. Businesses with robust eQMS have higher confidence ratings, enabling them to forecast and book revenue from new products sooner.
Streamline the audit and qualification process
Hosting audits can be challenging and present a clear and present danger to the business as a whole; unfortunately, manual tools make the audit process harder. The downside risks here could be loss of revenue (failed prospect or disappointed customer) or worse if connected to regulatory actions/fines. Innovator companies worry about the latter in particular, as delays eat into the limited window for protected IP status on new therapies. These results could translate into to devalued assets in an acquisition or merger upon diligence. The cost implications here are real and potentially huge.
Easy access to documents and data
Accessing critical documents and data is not just a need when hosting audits. Having immediate access to the documents you are looking for (a procedure or archived record) is compelling, especially if you need to prove that they have been controlled and preserved. In a business sense, what is the cost of losing a paper investigation or not finding the final, executed version of a manufacturing document? Moreover, having on-demand access to critical operating dashboards and data reports that you use to manage your employees and gain insights into at risk processes is indispensable in today’s business and regulatory climate.
Enforce compliance with defined procedures
GxP compliance mandates clearly defined processes as we march towards commercialization, and an ability to monitor compliance over time. Whether it’s timely execution of training or proven enforcement of a change control or CAPA process, the risk of not following a documented SOP can lead to day-to-day errors and costly, wasted effort chasing avoidable deviations/issues. Moreover the evidence of non-compliance can and usually does come back to haunt you in an audit.
Remember: ROI is critically affected by upfront capital outlays
The C-suite is focused on delivering shareholder value and innately see projects with high rates of return. And returns are very time sensitive-- so all other things equal, a project with lower up front costs but similar cash returns will always look better than the reverse.
A balanced/positive project has a reasonable upfront invested cost with tangible returns on a present value basis. So spending a lot up front for a small return will get rejected unless it is a strategic imperative. And it’s getting more difficult to justify shared costs of technology (e.g. servers) that may be part of delivering a chosen solution. Presenting reasonable investment relative to the tangible or strategic returns make for a compelling case for your executive committees.
Being intellectually honest about the true cost of ownership
Even the best RFPs have trouble discerning the difference in proposals some times. Doing this work up front makes it easier to manage objections or avoid obvious questions in the board room. It's up to the project team to gain a clear understanding of what's involved. Make sure to account for:
- All licensing costs now and into the future.
- Hardware or server costs and time-- even if in house. There is a cost for maintaining that equipment.
- What happens as the company grows over time?
- Validation costs-- can you do this in house? What is vendor providing?
- Training costs
- How easy will it be to roll out-- disruption can be very problematic
- Administration staffing going forward-- can we manage this ourselves? Do I need a dedicated/experienced FTE or consultant to do this?
- Cost of changes: How much configuration can I change on the fly with little / no cost?
- Helpdesk/support: What happens if I need to migrate more data/documents in future? How can I get help if I have a critical questions, especially during an audit? Is there an SLA-driven model for support?
- Cost of upgrades and maintenance: This is true for most all non-SaaS solutions, and it's particularly problematic. The hidden cost here is if you don't upgrade every year, is that a problem for you. In today's environment with shifting demands re validation/regulatory/privacy requirements, you can't afford to be stuck with an unsupported model or costly upgrade cycles.