With travel bans and stay-at-home orders in place throughout the US and many other countries, life sciences companies are struggling to maintain GxP compliance under increasingly challenging circumstances. Employees are working remotely- and so are FDA inspectors and auditors. And new regulations are being rolled out frequently in hopes of expediting the drugs, devices, and vaccines supporting the treatment and prevention of COVID-19.
Amidst this turbulent moment in our lives, with a global pandemic threatening us and our loved ones directly, and the specter of the coming economic recession already making waves, it is important to acknowledge that the hard work of life sciences development and manufacturing continues. And while global regulatory requirements remain in place, many companies will be forced to stretch budgets further and possibly with fewer FTEs (due to cuts). And in a new complication-- teams will have to truly do more (or everything!) remotely-- manage policies and related training compliance, investigate deviations, manage change controls, host/conduct audits, sign/review documents, etc.
For those relying on manual systems, these conditions only exacerbate the problems you already know about in terms of scalability and inefficiency. Some teams were already down the path in acquiring a platform only to find new concerns voiced about large price tags from your executive colleagues and boards.
So now more than ever we reiterate two key points:
- An eQMS platform can really help you operate more efficiently and in a more compliant way (see the articles below):
- Acquiring and implementing an eQMS just doesn’t have to break the bank. Really.
Give us a call, and let us help you spend more of your capital towards what really matters-- developing to your next clinical milestones or delivering for your clients.
Auditing a vendor starts long before you actually step into their office to perform the audit. For example, one of the first things you should look for when selecting a vendor is how willing they are to offer customers access to their platform- that may include performing demos of their solution, providing a sandbox environment or free trial, and responding to questions/ inquiries.
Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. As Director of Quality, he led eQMS implementations from the ground up. Given Mr. Banerjee's deep experience in selecting and implementing eQMS solutions in the life sciences industry, we asked him to share some tips for those who are just getting started or in the midst of their purchasing decision.
An electronic Quality Management System (eQMS) is the key in today’s world for preventing quality issues that can have life or death consequences for patients. Companies with tremendous potential in the regulated pharmaceutical industry can fail badly if they do not implement the right eQMS. Yet organizations that easily implement automated systems for many other functions often do not have an adequate eQMS in place. This is usually because the need for an eQMS is not understood early enough.
Marken, a UPS company, is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments, and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 54 locations worldwide for clinical trial material storage and distribution.
I often speak to quality leaders and other executives who boast that their paper-based quality management system is “perfectly sufficient” to meet the needs of their business. I just nod and smile because I anticipate that I will be hearing from them (in a panicked state) in the very near future when they realize the limitations of a manual QMS.
When you think about it, a department, job function or role within a company can be easily be compared to working towards a degree with a specific major. At most any University or College, there will be requirements that apply to all enrolled students as well as courses that are required for specific majors. And for each course requirement, there are quizzes, tests, and papers that need to be written to pass that course.
ZenQMS, the leading provider of cloud-based quality management solutions for businesses that desire a simpler path to intelligent compliance, today announced its Summer 2019 release. This release reinforces ZenQMS’s mission to meet customers where they are in terms of QMS maturity and deliver all of the benefits of enterprise-grade software in a flexible, approachable platform.
A new employee starts on your team. An SOP is updated. A new training video needs to be rolled out company-wide. You’ll need to update your training matrix and training folders for every one of your employees. Every.Single.Time.