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.
The new ‘reality’ for life sciences companies requires some immediate changes to Quality Management Systems (QMS) in order to ensure that the company remains compliant including employees, vendors, and patients/ consumers. Below are some specific impacts that COVID-19 has already had on Quality organizations and recommendations regarding how best to manage them:
IMPACT: With social distancing and travel bans, on-site GxP audits and vendor selection visits are now being conducted virtually.
Paper-based and manual document management systems will be highly problematic in the current environment. Those companies utilizing a cloud-based eQMS with document management features will be able to provide limited access to the system to auditors and vendors, regardless of physical location. Quality managers and other company representatives will need to be prepared to host audits virtually leveraging a combination of video conferencing software and an eQMS document management solution that can be shared on screen.
IMPACT: With a heavy reliance upon remote access and a distributed workforce, information security practices and protocols are now being tested more than ever.
With employees working remotely and potentially leveraging insecure home networks and computers, information technology and security are at greater risk of exposure to viruses, hacks, and more. It is a good idea to re-issue IT security policies and training with additional context regarding telecommuting. From a quality management perspective, this brings to light your initial assessment of the security and p.11 compliance of your chosen solutions-- whether being accessed via VPN or open internet.
IMPACT: Business continuity plans must be put in place (if they aren’t already) on how to operate when systems, critical products/ services, physical locations or personnel may not be available.
When establishing a business continuity plan, consider the risks posed to your operation if your systems could not operate, your physical location is not available, or you couldn’t get a hold of critical products or services that fuel your operation. Also consider how personnel shortage due to illness, mobility issues, or other factors may impact your business. After assessing those risks, prepare appropriate backup plans to support the operation and mitigate the risk, to name just a few, it is recommended to consider cloud based computerized systems that will not depend on physical location, think about alternate vendors who can provide products or services, have a plan of cross training of personnel to accomodate for personnel shortage
IMPACT: Training must be conducted--and tracked- virtually for employees working remotely
During these times of continuous change and frequent updates to policies and processes (SoPs), it is critical that Quality Managers are able to easily manage and update their company’s training matrix virtually. By moving the training matrix to the cloud, it should be relatively painless to deploy a new training sequence to specific individuals, teams, or business units. And when a new employee joins the team, it is simply a matter of designating their role(s) in the system and an appropriate training syllabus and courses will be assigned accordingly.
It is no longer realistic to expect that physical documents or live, in-person training sessions where everyone signs a training sign-in sheet can be the basis for your training compliance program. By moving training to a web/cloud-based platform, businesses can ensure that everyone is able to access critical SOPs and instruction content wherever they are and can submit their signatures electronically from any connected browser.
How can we help?
If COVID-19 has impacted your Quality organization, the ZenQMS team would like to help. Please contact us today for a free demo and strategy session, customized to meet the needs of YOUR business.