How Agility and DevOps can Reduce Turnaround Time for Pharma
The Software Development Life Cycle (SDLC) has been transformed by Agile and DevOps methodologies for a range of industries. The pharmaceutical companies are taking an immense amount of advantage from AI, RPA, Automation, DevOps, and Agile practices. Pharmaceutical companies have to comply with CGMP (Current Good Manufacturing Practice) regulations enforced by the FDA, which ensures best practices for manufacturing and quality control facilities by following strict guidelines for their components. Industrial pharmaceutical and biotech companies use Computer System Validation (CSV) to make sure that their software and hardware components are in line with the regulatory policies and guidelines.
Pharmaceutical industry quality standards can have huge implications on the consumer and can also have lethal consequences in case of a mishap. CSV technology ensures that each component is consistent, reliable, and scalable across the development journey.
With global health awareness on the rise, and technology democratizing, pharmaceutical players are growing across various nations and are giving fierce competition to large scale businesses. Large enterprises are also going on a shopping spree to acquire smaller companies, which are disrupting the pharma market. These companies are using Agile methodologies to accelerate development, regulatory, and quality assurance methods.
Key drivers of Agile and DevOps
Discipline
The agile methodology requires self-governance, accountability and a clear road map for success. By having a progress road map and a ticketing system for code repository, a robust framework can be created for CSV records, and teams can measure their performance continuously.
Automation
The DevOps methodology makes the development process more operational and infuses automation in the deployment and development cycle. Automation can help in generating computerized checks and leverage automatic tests.
Risk reduction
The goal of DevOps is to provide seamless and regular software updates by making the deployment cycle more reliable, controllable, and accurate. In the manual process of testing, if there are various changes in software development, it can lead to long-term operational downtime and damage the reputation of the stakeholders.
Ownership
The Agile manifesto ensures that in the development process, ownership from a scrum master and project manager drives collaboration and accountability in the team. The quality shouldn’t be compromised while applying these two methodologies, and it requires internal momentum and support from stakeholders to deliver quality-oriented and compliant software continuously.
Agile Project Management makes CSV cheaper
The CSV procedure is time taking and expensive. CSV is a part of the testing process generally used in the waterfall development model at the end of SDLC. It is evident that agile practices can make the SDLC significantly shorter and reduce the cost and time of development, iterations, and fixing software bugs compared to the traditional waterfall model.
Using agile practices in quality assurance can shorten the sprints, efforts and reduce the overall risk of new bugs in the development process. With continuous iterations in each level of project management can significantly reduce the cost and time. The agile methodology provides easy discovery of issues and developers can immediately respond and improve their code rather than waiting at the time of release in the waterfall development.
Automation testing for pharmaceutical companies can help enterprises to achieve faster regulatory compliances through agile testing and use cutting edge technologies to overcome bottlenecks. DevOps allows companies to use various techniques in pharmaceutical processes, improve quality assurance, and how they approach CSV.
Regression testing is also an essential part of the automation testing and can make up to 75% of all software testing for a pharmaceutical company. By automation, organizations can boost their productivity and ability to regularly update the services without damaging their reliability, trustworthiness and ensure that all their medical applications and services perform excellently for the users without any downtime.
Agile provides a competitive edge
Pharmaceutical companies have a prolonged software development life cycle as the development, and regulatory clearances of medicines can take years. It takes years for the government to test and pass any kind of medical products and services in the consumer market. However, consumer products like mobile health and fitness tracking apps are driving faster development life cycles to provide seamless user experience and gain market share without having a clash with the industry’s strict regulatory requirements.
The sharp rise in organizational development and agile methodology in banking insurance Healthcare pharmaceutical and manufacturing is leading to business transformation and faster time to market. Pharmaceutical companies will continue to have a range of regulatory and policy demands from the government. Moreover, integrating DevOps in the development cycle is augmenting pharmaceutical companies through seamless development and delivery.
