Working in a GMP environment has always been considered one of those "hands-on" industries, though some functions and areas can be approached remotely though automation and telecommuting. One of those GMP areas is Quality Assurance and the management of the quality systems.
The on-site presence of Quality Assurance and the use of paper documentation has historically been the norm for many GMP companies, with on-site audits and face-to-face meetings to discuss KPIs, investigations, corrective actions, and other quality systems interactions. While there will always be the need for an on-site presence for Quality Assurance, many of the modern-day tools can greatly reduce the numbers and hours of Quality Assurance staff required to be on-site.
SGS runs a network of integrated life science laboratories across North America, Europe and Asia-Pacific, which are all USFDA registered as Drug Establishments and strictly adhere to the GMPs according to 21 CFR 210 and 211. As an international network, the teams regularly use electronic means of communication, such as Skype and Microsoft Teams to conduct meetings and communicating at global and regional level. These virtual meetings have proven effective in bringing subject matter experts together and to effectively resolve issues remotely.
With the recent events of the COVID-19 pandemic and the need for physical distancing, local on-site meetings and training sessions now also use virtual technology effectively, with employees on-site attending safely from their desks, and in compliance with the GMP regulations.
Electronic QMS Tools
Customer audits, GxP compliance, and regulatory inspections require that the Quality Assurance team to have strong oversight of the Quality Management System (QMS). Previously, use of paper-based systems records for investigations, deviations, OOS, Change Control, Audit observations and CAPA would have prevented the management of the QMS processes remotely.
A strong Quality Management System (QMS) has always been a high priority for SGS and in 2019, SGS' global life Science network embarked on the implementation of TrackWise Digital (TWD), an electronic tool which enabled Quality Managers and Supervisors to take a remote, yet in-depth approach to managing the QMS. This "out-of-the-box" TrackWise offering has the advantage of bringing all the benefits of the popular on-premise version into a fast-implementation and highly compliant digital cloud-based version.
With minimal configuration, SGS was able to leverage much of the system validation that was performed and documented by Sparta Systems, the developers of the TWD software. Being able to qualify and implement the TWD QMS system in this manner offered us the advantage to prepare our laboratories to effectively manage the quality systems remotely when the COVID-19 pandemic struck.
Quality Events for the management of deviations and OOS investigations make it simple to discuss root causes and plan corrective actions. Virtual internal and external audits are easy to maintain through review of electronic QMS data and scanned documents. The ability to run customized reports with filters to drill down to specific processes or key problem areas and allows for quick action as well as the implementation of more effective CAPA.
The use of bespoke dashboards provides a quick and effective way to get a remote snapshot of the QMS across the entire network, from any location across the world, and allows important GMP decisions to be made. Key stakeholders can collaborate by accessing the specific Quality Events from various laboratory sites, review trends and reports, and meet virtually to manage root cause and risks safely.
Onevision Digitalization Project
SGS is deploying a Document Management System (TWD DMS) and Training Management System (TMS) through the OneVision laboratory digitalization initiative, which includes plans for an Electronic Lab Notebooks (ELN) and instrument connectivity.
Looking to the future, additional modules offer our laboratories many possibilities for remote execution of the Quality Control and Quality Assurance processes:
- Management of documentation and controlled forms remotely
- Assist with the documentation system life cycle
- Remote personnel training through designated training coordinators
- Virtual management of laboratory audits and internal audits
- Off-site data review using a centralize team where both electronic data and regulated system audit trails can be accessed remotely
- Electronic signatures approval and automatic system archiving will streamline the process and bring a more compliant approach to data integrity
The COVID-19 global tragedy has forced all of us to work together to think out of the box to utilize current and new technologies to keep essential businesses like SGS operating at the highest state of quality and integrity. In fact, it has prompted the ingenuity of many in the industry to come up with remote systems that will forever change how the QMS and GMP processes will be managed moving forward into the future.
An Integrated Network
SGS's global network of quality assurance experts work with regulators across Europe, North America and Asia-Pacific, and in all aspects of the pharma/biopharma industry. By working with SGS, manufacturers can access high-level industry knowledge covering all regulatory standards.
Contact us for more information:
Global Head Quality, Business IT & Business Excellence
t: +49 173 371 8799
SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 89,000 employees, we operate a network of more than 2,600 offices and laboratories around the world.