Everyone is in belt-tightening mode, and companies in life sciences are no exception. Neither is the compliance function at these companies. And yet compliance teams, especially at small and medium companies, need to strike a fine balance: keep quality management costs under control without compromising on quality, given the massive impact of non-compliance in life sciences.
With this tension in mind, there are two key factors compliance teams should keep their eye on when assessing an eQMS:
Insist on Tailoring: Best practices are the obvious starting point for any eQMS. However, one size does not fit all, and the ability to tailor the solution is critically important, as quality management specifics differ from company to company and necessitate a high degree of nuance and exactitude. Ensure you can tailor the solution, easily and at no extra cost.
Ensure Cost Control: As anyone who has remodelled their home knows, it is rare to to get an accurate cost estimate from the contractor up front, often leading to projects that are far longer – and far more expensive – than initially planned and budgeted for. The same is true for companies implementing an eQMS. While the upfront cost of licensing is clear, the actual cost of the project – including the all-important implementation and validation – is unclear. For small and medium companies in particular, where the ability to accurately budget is so important, these costs can derail a project or come at the cost of another project whose funds are now channelled to cover the hidden costs of implementing and validating an eQMS.
So when assessing a new eQMS, companies should ask these three questions:
- Does the licensing fee include implementation costs?
- Does the licensing fee include validation costs?
- Are the ongoing system updates free of charge?
If the answer to any of these questions is no, you are likely getting into a home remodelling project with hidden costs that will run over budget (and schedule). In today’s turbulent market, you can’t afford to go over budget, but you also can’t afford to compromise on the quality of your system. Find a solution that can deliver both – a tailored solution with clear cost visibility, There is no need to compromise.