Rob Harrison, Research Analyst, LNS Research
When an organization has determined a quality process improvement imperative and resolved to take a time-sensitive course of action by harnessing technology in the form of EQMS, there are critical elements that must be considered to ensure success. These elements relate specifically to meeting the timeline demands while guaranteeing the solution delivers the correct functionality in a secure and responsive manner without compromising user adoption and potential for improvement and expansion. In a recent Quality Management survey, LNS observed a significant shift in EQMS delivery preferences from traditional on premise to the cloud. This shift was particularly noticeable for medical device manufacturers as shown below. Many of these deployments have the goal of speed as a determining factor in their selection of delivery model.
Many medical device manufacturers find themselves in scenarios that demand timely action to improve quality management processes. Some are focused, self-imposed improvement objectives while others are driven by regulatory issues; a warning letter, or citation for example. The maturity of cloud-based EQMS solution offerings has proved an excellent way to meet the requirements of rapid deployment. Rapid EQMS deployments allow organizations to resolve immediate problems in a specific process like complaints or document management, and subsequently leverage this for future expansion into other less immediate but equally important processes like audits or supplier quality management. An organization looking to shift their QMS processes rapidly, whether from an outmoded, static paper-based approach or to consolidate from disparate databases and/or departmental data artifacts should, at a minimum, ensure they consider the following 5 components:
- Security & Governance
- Disciplined Scope & Validation
- Out of the Box Configuration & Best Practice Content
- Reports & Analysis
Security & Governance
As quality leaders and their delegates search for the right solution to meet their needs, they must ensure they understand their IT group’s security and governance policies. Input from IT is critical to ensure that options like a private cloud as opposed to public cloud, single tenant vs. multi-tenant, and appropriate monitoring and physical security benchmarks are met or exceeded. Beyond the cloud environment, off site backups and disaster recover procedures are also likely to be scrutinized. EQMS providers offer various levels of monitoring and managed services. Seek comprehensive, documented evidence of security and governance procedures so as not to delay or compromise the project with ambiguity or risk of security exposure. Deploying rapidly does not allow for this fundamental diligence to be circumvented.
Disciplined Scope & Validation
The driver for a rapid deployment is typically encapsulated in a narrow scope. Quality management is a pervasive set of processes that span the value chain. It is very tempting and easy to become the victim of scope creep in a rapid EQMS deployment. To avoid derailing the original objective, broader, longer-term scope should be considered, mapped, or included in selection criteria, but should not be part of the rapid deployment schedule/project. Subsequent phases are based on the success and results of addressing the immediate quality imperative. Validation is especially important for any quality operations that sit under the FDA’s regulatory oversight. Validation for cloud-based solutions should only demand the PQ element. IQ and OQ should rest with the vendor as a responsibility. Discipline in sticking to original scope is important so as not to inflate the overhead for validation efforts.
Slick interoperability by design is of great importance when selecting a solution to deliver in a rapid deployment scenario. For example, when addressing complaints management, corrective and preventive actions (CAPA) are a key component of the overall process. Knowing that these two distinct components of functionality work hand-in-hand in an intuitive and easily executed manner is a boost to the adoption and usability challenge, but also aids with initially maintaining narrow scope with provision for later expansion.
Out of the Box Configuration & Best Practice Content
Leveraging pre-configured workflows, business rules, and common roles and responsibilities is critical to success in rapid EQMS deployments. Building from scratch will take longer and regularly invokes decision loops that delay roll-out. To remain on track, leverage as much pre-configured or template content as possible and lean on the best practices a mature vendor with domain experience can offer. You must ensure you have the ability (without vendor intervention) to adapt where necessary, but that becomes part of the natural improvement cycle infused with user feedback and experience.
Reporting & Analysis
Give reporting equal functional status as capturing and managing data. Identify a baseline set of reports to include as part of your initial rollout. Having clearly understood the specific issues your rapid deployment is addressing, you will have reporting and intelligence demands front of mind. Use this to aid selection decisions and include reporting and analysis output as a deliverable of the implementation—not a second phase. The reporting and analysis baseline can be expanded as efficiencies are gained and newfound visibility into the process presents itself. With early success in the EQMS deployment, an organization should be prepared for the initial “push” type rollout to evolve into one that is pulled by the organization’s wishing to emulate the success across additional enterprise quality processes. The previous consideration of broader scope and interoperability will prove valuable from this point forward.
Strategies for Rapid EQMS Deployment
Free White Paper
EQMS automates and centralizes traditionally disparate business processes and technology. In this white paper, LNS Research explores effective strategies for rapid EQMS deployment.