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.
While there has been some debate about the security of data stored in the cloud, the reality is that there is a great deal of emphasis put on ensuring security with cloud applications.
The real question that you should be asking is, "Is your QMS at risk if it is not in the cloud?" The answer to that question is, "Absolutely." Why can that be said?
Paper-Based Systems and Business Continuity Planning
Organizations that use on-premise, paper, and spreadsheet-based quality management systems face a challenge when designing a viable business continuity plan.
An essential part of a comprehensive risk management strategy, a solid business continuity plan is designed to protect the assets and processes of a business in the event of a crisis or disaster.
Ignoring the necessity of a business continuity plan puts a company at considerable risk. At the least, a disruption in business processes caused by a disaster event may cause you to lose clients. At the worst, it could spell the end of your business entirely.
According to FEMA estimates, 40 percent of businesses do not reopen following a disaster. On top of that, another 25 percent fail within one year. These statistics underscore the seriousness of failing to adequately plan to protect your business in the case of disaster.
Last Wednesday, Ed Morris, from the Morris Group delivered an engaging webinar around a topic that is near and dear to many of us in regulated industries. Ed presented, "Is data center qualification still relevant?" to a group of customers and industry experts. In his informative and detailed presentation Ed dealt with these critical topics in a world that continues to march towards Cloud, SaaS and hosting. Some highlights included:
- GAMP V vs Reality
- What is a qualified Cloud environment
- GMP, ISO, IEEE and CFR Requirements
- What is a high risk data center?
Even if you missed it, you can view the webinar (or download the slides below)
Amazon Web Services was recently named a leader in the 2015 Public Cloud Storage Services Magic Quadrant report, and it has particular significance to those who depend on cloud technology. Here at ZenQMS, we want to share the report with you for a good reason. We rely on Amazon Web Services as our main infrastructure for our electronic quality management system platform.
As the cloud continues to dominate the software landscape and become more critical in regulated environments, questions arise over data center validation. Join us on Wednesday December 16th at 1:00pm Eastern as we join Ed Morris of The Morris Group to discuss what data center validation means in the age of cloud-based offerings and virtual server infrastrustures.
We spend a great deal of time focusing on data security in our applications, and picking the right infrastructure partner is a critical consideration. Forrester research just put out an updated analysis worthy of your review.