![]() Within a project space, systems would manage their user requirements specification, functional specification, validation protocols, test cases, execution results, evidences and defects. Each system would get a project space created from a process template. Validation process packages can be designed in the process governance centre. Inspired by ‘Quality by Design’ principle, QSpace was built with three functional components – Process Governance Center, Project Space and Executive Insight Center. But, Archimedis realised the available GxP validation software were either insufficient or required additional effort to make them regulatory compliant.Īrchimedis designed and built a software system called ‘QSpace’ to address this challenge. It became clear that a software system would be mandatory to control and manage the diverse GxP validation needs. Also, such an approach would expose more compliance risks (such as data integrity concerns) than they addressed. If manual (paper-based) validation approach was adopted, Archimedis would not be able to scale rapidly. On the other hand, GxP validation had to be planned for each new system and any existing system that historically lacked objective evidence. So, on one hand, Archimedis was upgrading the facility with utility systems, manufacturing equipment, lab instruments, software and other computerised systems. 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. 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). To ensure that the systems operated consistently, Archimedis also introduced digital practices for key business processes.Īs the regulatory requirements would insist every system had to be validated in accordance with applicable regulatory requirements before they were made operational. 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. Archimedis quality leadership worked tirelessly in establishing a quality management system and ensured that people adhered to the same at all times. A stellar quality leadership is key in transforming an organisation to a higher level of quality and regulatory maturity. Once the MHRA ace team was formed, people followed people. With its young and aspiring leadership, Archimedis was able to attract talents who had worked in highly regulated pharma markets. To realise its global vision, Archimedis had to make a major overhaul across people, process and technology. 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). Having succeeded with domestic business in India and backed by promising product pipeline, Archimedis laid out a business strategy to enter the UK market. ![]() ![]() ![]() An insight by Duraisamy Rajan Palani, MD, Archimedis Healthcare Duraisamy Rajan PalaniĪrchimedis is an aspiring pharmaceutical manufacturing firm. Realising the value QSpace can deliver to life sciences organisations, Archimedis has recently commercialised QSpace software. 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. Archimedis is an aspiring pharmaceutical manufacturing firm with a promising product pipeline. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |