Archimedis is an aspiring pharmaceutical manufacturing firm with a promising product pipeline. To succeed with its global strategy, Archimedis developed a cost-effective and user-friendly software solution (QSpace) to manage all the GxP validation requirements across facilities, utility systems, manufacturing equipment, lab instruments and computerised systems. Realising the value QSpace can deliver to life sciences organisations, Archimedis has recently commercialised QSpace software. An insight by Duraisamy Rajan Palani, MD, Archimedis Healthcare
Archimedis is an aspiring pharmaceutical manufacturing firm. Having succeeded with domestic business in India and backed by promising product pipeline, Archimedis laid out a business strategy to enter the UK market. As a pre-requisite to entering the UK market, Archimedis was required to obtain MHRA accreditation (MHRA stands for Medicines and Healthcare products Regulatory Agency which is UK’s regulatory authority for healthcare products).
Strategy
To realise its global vision, Archimedis had to make a major overhaul across people, process and technology. With its young and aspiring leadership, Archimedis was able to attract talents who had worked in highly regulated pharma markets. Once the MHRA ace team was formed, people followed people. A stellar quality leadership is key in transforming an organisation to a higher level of quality and regulatory maturity. Archimedis was fortunate to have one. Archimedis quality leadership worked tirelessly in establishing a quality management system and ensured that people adhered to the same at all times. In parallel, factory modernisation effort was triggered, which included installation of new water purification system, renewal of air handling unit (AHU), procurement of manufacturing equipment and lab instruments. To ensure that the systems operated consistently, Archimedis also introduced digital practices for key business processes.
Challenges
As the regulatory requirements would insist every system had to be validated in accordance with applicable regulatory requirements before they were made operational. For instance, if a new lab instrument was installed, it had to be validated with objective evidence that the system would operate as intended and designed for (a process widely known as GxP validation). As a rule of thumb, any system that would impact patient safety, product quality or data integrity would be termed a GxP system and they would be subjected to GxP validation process.
So, on one hand, Archimedis was upgrading the facility with utility systems, manufacturing equipment, lab instruments, software and other computerised systems. On the other hand, GxP validation had to be planned for each new system and any existing system that historically lacked objective evidence.
If manual (paper-based) validation approach was adopted, Archimedis would not be able to scale rapidly. Also, such an approach would expose more compliance risks (such as data integrity concerns) than they addressed.
It became clear that a software system would be mandatory to control and manage the diverse GxP validation needs. But, Archimedis realised the available GxP validation software were either insufficient or required additional effort to make them regulatory compliant.
Solution and implementation
Archimedis designed and built a software system called ‘QSpace’ to address this challenge. Inspired by ‘Quality by Design’ principle, QSpace was built with three functional components – Process Governance Center, Project Space and Executive Insight Center. Validation process packages can be designed in the process governance centre. Each system would get a project space created from a process template. Within a project space, systems would manage their user requirements specification, functional specification, validation protocols, test cases, execution results, evidences and defects. Systems would also can create releases to allow for incremental evolution of systems. Executive insight centre gives ‘bird’s eye view’ visibility into systems quality and compliance health at the organisational level.
Due to its inclusive design, traceability is automatically built and maintained between entities. Regulatory reports can be generated in single click. With electronic signature and CFR Part 11 compliance, QSpace allows users to collaborate remotely through a configurable review and approval workflow.
In QSpace, an Intelligent Compliance Engine (ICE) actively manages compliance needs, while the end-users can apply all their focus on system quality.
Outcomes: Accomplishments, changes, lessons learned
QSpace is very user-friendly and hence users could get on board quickly and operate with high efficiency with a very short learning curve. Powered by advanced data visualisation techniques, minimalistic dashboard views reflect system quality and compliance at first glance.
Key value delivered by QSpace are:
- End-to-end GxP validation process automation (process design and adoption)
- In-process compliance to regulatory requirements
- Assured audit-readiness all the time
- Minimal dashboard that reflects system quality at the first glance
- High productivity and pleasant user experience
At Archimedis, QSpace became the central repository of all GxP validation assets.
Way forward: Future steps
Life sciences organisations thrive on scientific discovery and product quality. In taking a scientific innovation from lab to scale, computerised systems play a vital role. They infuse and catalyse process efficiency and advance products to the market. But, for the computerised systems to be deployed and to remain in operation, they should consistently meet the regulatory requirements, a practice collectively known as Computerized Systems Validation (CSV).
CSV is a cumbersome yet mandatory process in the life sciences industry. And it should be done for hundreds of regulated (GxP) systems that automate critical business processes like drug discovery, device design, formulation, laboratory, clinical, manufacturing, supply chain and post marketing surveillance.
It is imperative to maintain quality and compliance at the speed of business. This is exactly why Archimedis has commercialised QSpace for other aspiring life sciences organisations around the world.
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