Ensuring Safety and Quality for Medical Device Development During Pandemic
All over the world, businesses and even entire industries have been shaken by the impact of COVID-19. While the impact of the pandemic has been overwhelmingly negative in many areas, the MedTech industry has experienced an unexpected transition which has brought a whole new level of risk. The transition from in-office to remote work requires a level of care and detail in the regulated industry. Below we will identify which areas need a proper transition to ensure quality processes are maintaining a quality standard.
Areas Affected by Remote Transition
With a new reality upon us, teams including startups developing solutions for the healthcare and life science spaces will be forced to update their processes. Work performed “outside the traditional boundaries” will become more feasible and more common even for smaller companies. This starts with a new direction in how operations are handled by leaders in the following areas:
In comparison to working in a co-located space, distributed teams must perform regular functions in a completely new environment. Since employees cannot simply walk over to one another’s desks or office to check how projects/work is progressing, they must set aside time to communicate virtually.
Startups around the world have adopted video conferencing tools to ease the transition of remote communication. Yet, these digital solutions for communication can fall short and prolong workflows. Where there is lack in communication can come a lack in the ability to assure quality processes are being efficiently implemented in your product development and production. Extra precautions and due diligence must be taken to ensure quality in the regulatory space.
Communication is a crucial base for remote work and must be paired with the right tools to manage key deliverables. A starting solution is to implement a quality system that may solidify member tasks and responsibilities during remote transitions of work closing gaps in development.
Changes in Documentation
In an industry that enforces security through proper documentation, companies developing medical products must continue to efficiently deliver signatures and approvals despite the remote transition. If your team relies on paper, travel restrictions and delivery delays will make it difficult to get physical signatures.
Your team needs a centralized documentation system that can digitally organize any important documents and messages avoiding potential delays and reworks. Adopting a digital system that eases the obstacles of distance will grant your team more time and efforts for product development.
Shifts in WorkflowsUltimately, there are changes in workflows that can disrupt your product development. While paper and frequent check-in meetings are an obvious sign of manual processes being in place, inefficiencies also exist in the digital realm. For instance, managing processes through email or shared spreadsheets can still be cumbersome, slow, and inaccurate.
- The sequence of steps taken to fulfill a particular objective fueling your organization’s operations and solution.
A strong solution for revising workflow management during remote transition is by automating them. Instead of emailing a contract around for review and approval, your team can have everyone involved by using a quality management software that can grant digital access to the respectful members. Relieve yourself of the burden of:
- Finding who should be involved.
- Locating the right document version.
- Identifying the next steps.
Automation is Key
As you learned above, having a centralized automated system will further shape the quality standards of your processes during this unprecedented time. Without a Quality Management System (QMS), your team may fall short in making an efficient transition to remote work. Reviews and approvals should be a standardized and seamless quality process for your team slashing any communication errors despite geographic location.
Sierra QMS is a QMS for life sciences that will automate workflows and documentation and instantly increase the level of security your team needs to deliver a quality solution. Having the proper tools to manage your business during this time starts by centralizing all activities and tracking the progress of work to avoid setbacks. In a remote working environment, workflow automation makes all of this possible.
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