SOLABS’ Enterprise Quality Management Software will maximize your return on investment (ROI) by:
Business cases for EQMS software implementation are developed using a sub-set of these benefit categories:
Scenario: Your company is growing or anticipating high growth
In this case, it’s better to be safe than sorry. By implementing EQMS software, you will ensure that the software is well in place when you start to feel the impact of your organization’s growth. Implementation of EQMS increases operational efficiency by allowing you to handle increased volumes without the need for increased staff. Moreover, EQMS helps your organization avoid the risk of non-compliance by automating critical elements of your quality management system and ensuring that you remain in control of compliance requirements.
Scenario: Your company has a stable hybrid or paper-based QMS in place
This is the perfect time for an organization to implement QMS software. Implementation of EQMS at this stage allows the organization to take advantage of reduced cycle times and plan for a smooth implementation. For example, clients of SOLABS QM have reported reductions in cycle times by more than 50% following integration. Therefore, if your organization’s average cycle time for closing a change control prior to EQMS implementation is 100 days, consider the various impacts of reducing it to 50 days. This is a considerable, quantifiable benefit for your organization. Similar reductions been observed in document approvals, quality event reporting and investigations, translating into a fantastic post-implementation return on investment .
Scenario: Your company is virtual and deals with multiple external partners
Implementing an EQMS solution can be a great asset to virtual organizations. If your organization requires efficient collaboration with partners and monitoring of supplier quality, an EQMS is your solution. In many cases, clients of SOLABS QM collaborate on quality agreements, audit observations, CAPA actions and status reporting with partners. To accommodate their needs they create external system users with limited access to specific information and actions within SOLABS QM. Including partners for approvals and ‘sign-offs’ in your EQMS instead of having to physically send documents greatly contributes to cost savings. An added benefit is that this type of automation is environmentally friendly.
Scenario: Your company may be at risk of non-compliance with regard to certain aspects of its quality management system
Implementation of an EQMS is no longer an option. Avoiding non-compliance is crucial for Life Sciences companies. The company may not have a large budget allocated to implementing an EQMS—in this case, it’s best to favor a multiphase approach. In phase 1, limit your scope and focus strictly on the most critical areas. By doing so, your organization not only reduces immediate costs, but also reduces implementation time, ensuring your system is up and running before the risk becomes too real. For example, a good place to start would be complaints management, where a strong return on investment case can be demonstrated.
Source: New Research reveals that quality management delivers E90 billion to the UK economy, 26 June 2012, IRCA.
Pharmaceutical companies spend 6% to 15% of their gross revenues creating and managing documents, so any improvement in such document creation and management provides substantial gains and/or reduced costs to a company.
Many pharmaceutical companies would have a hard time defining quality strictly in terms of dollars. However, what everyone does know—without a doubt—is that poor quality can cost you millions in terms of a warning letter clean up or even a consent decree:
Source: How to Optimize Your Quality System To Ensure FDA and ISO Compliance, April 30th, 2013, JM Pickett.
Reduced cycle times for clients using SOLABS QM to manage Change Control Requests.
Estimate of yearly savings in time per employee:
*Searching, archiving, saving, retrieving, organizing, approving, circulating documents
