Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions
Time waits for no one. No one is more aware of this than companies that cater to the world’s growing health care industry. These organizations walk a fine line every day between producing life-altering solutions as quickly as they can conceive of them, and doing so in full regulatory compliance and to 100-percent quality.
Life Sciences companies today are performing this balancing act between productivity and quality amid myriad growing pressures from customers, suppliers, and regulators, as their operations are having increasingly global impact. When you sprinkle risk management concerns and reputation management into the operations mix, the pressure grows even stronger.
Fortunately, with the help of enterprise-wide quality management software solutions that align with their operations, manufacturers are able to maintain a strong, steady grip on their product quality without compromising productivity.
But what about putting an actual solution in place? When the time comes to implement a quality management system (QMS), what matters more: need or speed? Is it more important to stand up a system quickly and target a rapid implementation, or is it better to take things more slowly to make sure it’s done right? The truth is, both are equally important, so the challenge is to adopt an implementation strategy that addresses both.
The Time for Rapid Implementation is Now
Once they select the right QMS solution to meet their needs, Life Sciences organizations can’t afford to wait months or years to begin seeing the value of the investment. Whether quality goals are driving the implementation timeline or the need to quickly demonstrate compliance to regulators, savvy companies can employ a quality management system quickly AND properly… if they do it the right way.
To start the wheels running at maximum velocity, without sacrificing quality along the way, there a few considerations to keep in mind.
1. Avoid Mental Overload. Lean on your QMS Solution Provider.
Before implementing any enterprise-wide software system, a company needs to have a clear vision of its expectations of that system. If the goal is to be up-and-running in a compacted timeframe, the implementation checklist can be downright intimidating. But it doesn’t have to be. To avoid mental overload, and potential quality slips, it’s critically important to take one thing at a time. A top-notch software firm will take the walk with you through the checklist.
Here’s what you should anticipate along the way:
- Make clear the high-level objectives and requirements of the system you chose to implement. During this first step, your solution provider will develop a statement of work, allocate resources to your implementation, and establish an agreed-upon project timeline.
- Bring your Quality and IT teams together with the provider’s team to make sure everyone has read the playbook and is on the same page from the outset.
- Clearly communicate your company’s solution requirements – what do you want your QMS to look like? – then evaluate any design options presented by your provider to determine the best design to meet your objectives.
- Rely on your provider to do the heavy lifting of building your solution according to your requirements and industry best practices.
- Reunite with your provider to test out the newly built solution within your actual working environment in a Conference Room Pilot to ensure that the solution works as designed and meets your requirements.
- Finally, together with your provider, initiate production deployment and look to them to lend support until you’re confident you’re securely on your way.
2. Consider the Comfort of the Cloud.
Another thing that will save you time is a QMS that runs in the Cloud. Because it is delivered via the Internet, it completely eliminates the time required for the system’s installation and setup at your facility. A good cloud provider should offer adequate implementation assistance for configuring and validating your application so your users can be up and running quickly.
Additionally, a cloud that meets stringent industry and regulatory standards by offering advanced security features and data privacy protection, will do wonders for your confidence in your system’s quality competence. If possible, also look at finding a Cloud with scaling capacity that will allow you to expand quickly and address your growing business needs over time. In the Cloud, you can be sure you’re meeting the needs of a mobile or decentralized global workforce.
Remember that operating in the Cloud also means you don’t have to be hands-on with day-to-day operations so you have time to focus more on enhancing your overall quality and compliance processes and less on the technology that manages them.
3. Offer Training and Support to Ensure Continuous Improvement.
When continuous Quality is the goal, you don’t want either the need for a QMS software solution, nor the speed at which it’s implemented, to confound your organization’s staff. As such, training and support is mandatory if you want to empower employees to work with the system. Even more so when you undergo a rapid implementation for QMS. Just as you should walk alongside your solution provider to stay on the same page of the implementation playbook, you should ensure your entire team is on the same page at all times, post-implementation.
Involve them in each step of the deployment, and offer ongoing training, to encourage continuous, active engagement with the system. If you’ve selected a solid QMS provider, they are going to provide you the training materials and support needed to be up-and-running quickly and for the long haul.
Don’t Delay Entering the On-Ramp to Quality
Once you’ve made your case for a QMS rapid implementation, these considerations should help feel confident that you’re making the right choice. At no point should you have to sacrifice quality for speed. In fact, the more quickly you’re up-and-running, the sooner you’ll reassure your customers and industry regulators that providing quality products and services is your organization’s number one goal.
SmartStart: The Smart Path to Enterprise Quality Management
SmartStart delivers EQMS to your team in just 30 days. SmartStart is the same SmartSolve® solution deployed on-location at customer sites. Download this data sheet to learn how SmartStart can deliver EQMS success to your organization.