Managing Medical Quality in a High Stakes, High Standards Environment

Breakthroughs in medical science can enhance quality of life for us all. Especially when lives and livelihoods are at stake, it’s critical to get promising medicines and medical devices to the masses, fast.

Challenge: Meeting Government Standards in a Timely Manner

Regulations from such agencies as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are designed to assure the quality, safety and efficacy of these drugs. Yet, for medical device and pharmaceutical companies, meeting national and international government standards is an onerous and time-consuming Task.

Efforts to adhere to government regulations can cause strain on organizations’ financial and human resources. Furthermore, such quality issues as medical device defects and drug contamination could put pharmaceutical and medical device companies – and impacted patients – at risk.

Solution: Quality Data Management Software

To protect patients, as well as their brands, medical device and pharmaceutical companies are turning to quality data management software solutions. Among them is Quality Data Assurance (QDA) from ASI DATAMYTE.

Quality data management solutions like QDA make it possible for medical device and pharmaceutical companies to achieve faster drug and medical device speed to market, and fewer on-the-job headaches.

The best quality data management solutions include a robust suite of modules and tools that work in a stand-alone or fully integrated manner. This way, medical device and pharmaceutical companies can purchase the modules they require right away, and easily add modules as their needs evolve.

For example, medical device and pharmaceutical companies use the QDA Laboratory Information Systems Solution (LIMS) module to connect and integrate their laboratories with production operations to reduce data-input error and get information in place where it’s required throughout either their LIMS or, if in use, their entire QDA system immediately. LIMS also allows users to plan and automate tests according to required standards; support lab personnel with instructions, documentation, and the creation of certificates and reports; and compare results among all applicable labs and production lines at once. The functionality of LIMS ultimately helps medical device and pharmaceutical companies reduce paperwork, errors and uncertainty throughout manufacturing processes, while optimizing workflow.

In general, quality data management solutions and the modules within should allow medical device and pharmaceutical companies to perform the following functions, to name a few, when planning and implementing large medical device and drug development projects:

• Meet detailed quality specifications in an efficient manner

• Verify suppliers and their incoming product quality quickly to ensure safety

• Identify issues and risks early on in the planning process and immediately throughout production

• Access and update data, documents and forms in real time

• View compliance checks and mandates on command

• Integrate reporting and administration functions with ease

• Achieve data accuracy, traceability and regulatory compliance

Conclusion: Quality Data Management Software Enhances Medical Device and Drug Speed to Market

Medical device and drug safety and efficacy is a top concern among medical device and pharmaceutical companies, and the government agencies that regulate them.

Compromising quality for medical device or drug speed to market puts companies – and patients – at risk.

Quality data management solutions, such as QDA, help medical device and pharmaceutical companies reduce the time and effort it takes to get safe and effective medical treatments to the marketplace, and – most importantly – to the patients who need them most.

For more information about QDA, visit our product page or contact us today.

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