Biotech and Life Science News, Jobs, and Events for the BioHealth Capital Region

This article is a guest post authored by Gaurav Walia, M.S., Senior Global Director and Principle CSV/CSA and DI SME/Consultant, PQE Group

The COVID-19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical, and Medical Device industries as well as for companies researching, developing, and manufacturing medical prescription products around the world. 

In 2020 and 2021 (and, to some degree, continuing today) all processes were dramatically impacted by the pandemic as many employees, consultants, and others were restricted from physically working in the office or manufacturing facility, resulting in skeleton crews and largely remote workers. Critical processes throughout the development lifecycle of pharmaceutical, biotech, and medical device products were required to transition from in-person to virtual procedures and processes. 

And of course, the virtual programs and platforms, which were available but not as widely used prior to the pandemic, required time to be developed or enhanced to a point where they could be utilized properly for the important, and highly regulated, practice of bringing a pharmaceutical, biotech drug, or medical device to market. 

RELATED: Digital Transformation in the Life Sciences Accelerates, Set to Reshape Industry Across Next Decade

Small, mid-size, and even many large companies around the globe, each of which must audit internal processes and procedures, traditionally have small on-staff audit teams. The audits required are numerous and can range from materials and data integrity, software, and technologies to third-party vendors engaged with their organizations. The impact of the pandemic, which created a dearth of on-site employees, has made it even more difficult for these teams to accomplish these highly critical audits/investigations. 

As a result a paradigm shift has occurred with many of these companies, which are now transitioning from paper to electronics, advanced technologies, and Cloud data storage, all of which have their inherent risks. These risks can be severe and include damage from extreme weather (think hurricanes or tornadoes), machine breakdowns, and, perhaps most dangerous, cyber-attacks which can mean stolen data, hacked systems, and loss of proprietary data and financial assets. 

Backups of data and archives can help minimize some of these risks, assist in disaster recovery, and provide business continuity. New technologies such as Software as a Service (SAAS) and cloud computing are providing vital solutions. 

While these protections are essential, we must still proactively ensure our companies’ security as well as maintain its ongoing regulatory compliance with everything related to the development of a pharmaceutical/biotech/medical device product. 

While thinking about transitioning to virtual audits/inspections, it is important to identify any potential problems that might occur, identify solutions, and accomplish whatever remedies are required prior to the occurrence. 

In considering all of this, questions to keep in mind include: 

While virtual audits and assessments are not perfect and efficiencies are still evolving and being enhanced, it can be easier to accomplish them using remote technologies. You can determine when the audits and assessments will occur and who will participate. More auditors and experts from diverse corners of the world can be involved. Chat features can quickly accommodate questions and provide answers. 

When you have internal audits, third party inspections, or the FDA deciding to inspect your organization, being prepared will provide great advantages. Having designed, implemented, and executed virtual assessments, audits, and inspections with remediation for whatever issues were identified will be well worth your efforts. 

These virtual assessments should include:

Implementing a virtual audit/inspection process (especially during COVID) can better ensure your facility’s cleanliness and lack of contamination exposure. You can focus on different quality systems over time—perhaps audit five areas over one year’s time—but be certain to ensure all are in compliance with internal/regulatory requirements.  

Doing this can help you avoid FDA rulings such as a 483 warning letter, product recalls, or worse, a Consent Decree.  In the long run, all of this will save you time and money, maintain your company’s reputation, and help guarantee the successful development, approval, manufacturing, and launch of a product that will ultimately treat patients and save lives.

PQE Group’s highly professional subject matter experts can help your organization maintain full compliance in anticipation of a remote audit, assessment, or inspection. PQE offers expert support in preparing for internal audits and can help you with third-party (supplier) audits, vendor risk management (Technology, Software, and Cloud Vendors), inspection readiness, remediation to correct problems, data integrity, and more while utilizing new Smart Glasses (augmented reality technology) with proprietary PQE Group remote access technology to access data and systems virtually/remotely. 

PQE can provide your company the best means by which to share your data (via laptop, phone, or other devices/platforms) and determine how your data is controlled and accessed virtually. In addition, we can help you ensure your IT systems are safe from ransomware, hackers, and other cyber threats. By partnering with PQE Group, you can be confident that your company will maintain FDA (and other regulatory agency) compliance and your product can be safely developed and manufactured – even if done remotely.  

About PQE Group PQE Group is an ISO 9001-certified technology solutions and compliance consulting services company for the life sciences industry, providing global capabilities deliverable throughout the entire product quality life cycle.  Established in 1998, PQE has 30 offices worldwide and more than 1500 industry, subject matter professionals. PQE specializes in areas including Data Integrity Assurance, Digital Governance, Qualification and Engineering, Laboratory Excellence, Quality Compliance, Regulatory Affairs, and Third Party Audits. It also has a proven track record managing large multi-site projects as well as small, medium, and start-up pharmaceutical, biotech, and medical device clients. 

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