Insights Blog Why Quality Engineering Has Become a Top Priority for Pharma Companies


Why Quality Engineering Has Become a Top Priority for Pharma Companies

Pharma companies face new technological (and regulatory) challenges these days, and more to come in the near future. This is how quality engineering is helping them adapt to this technological shift.

Pharma and quality engineering

The quality engineering processes of computerized systems, which encompass both quality assurance and control as well as validation & verification, has always been critical to the pharma sector. It has ensured that consumers are entirely insulated from any harm caused due to poor quality processes within the industry. This process also drives QA testing engineers in the pharma companies to work towards improved operational efficiency and reduced costs.

New technological developments have always positively impacted how quality standards are maintained in the pharma industry. A 2021 report also reiterates the same and highlights how AI, Big Data, Robotics, IoT, Cloud Computing, etc., are disrupting the existing tech space in the pharma industry and aiding in increasing the overall efficiency of the pharma sector.

However, to function effectively and aid the pharmaceuticals sector, most of these technologies need to pass through the software quality assurance process.

Here are some pointers on each technology to briefly explain this technological shift in pharma and the essential role that QE (Quality Engineering) plays in it.

Regulation and compliance

The pharmaceutical, healthcare and medical devices industries are highly regulated and audited, making compliance a major risk for all operations. Software applied in the manufacturing and quality control of pharmaceuticals or the documentation of these activities is judged against quality expectations set by government agencies, such as the U.S. Food and Drug Administration (FDA), where the intent is to prevent the distribution of potentially hazardous drugs that were adulterated or mischaracterized by incidents that can be traced to faulty software. Data integrity is also a major concern, with systems implemented in manufacturing, quality control, and enterprise systems.

Companies in these industries need extensive, proven, compliance expertise, reducing risks, and giving them a competitive edge with expert services, including:
– Setup of quality systems
– Computerized system validation
– Data integrity compliance
– Quality engineering across all types of software

Cyber security

Cyber Security is a relatively new issue in the pharma and medical world, with new regulations constantly updated. This is more apparent with systems moving to the cloud, mobile applications and IoT devices becoming common place.

This field requires a very high level of expertise usually not found within non-specialized IT organizations. These systems often manage sensitive and private information relating to individuals or patience that makes them particularly attractive targets for hackers, which only highlights the importance of pristine cyber security measure in the pharma and medical industries.

A great deal of innovation is required to maintain cyber security in the pharma industry. On top of traditional PEN testing, shift-left cyber security testing is essential in order to enable pharma and healthcare companies to automate cyber test cases and perform cyber security testing at a much earlier stage, which greatly reduces the cost impact of cyber security in these sectors. By finding cyber vulnerabilities early, and automating the cyber testing process, the risk associated with fixing these vulnerabilities are massively reduced providing financial, legal and reputation safety.

Internet of Things (IoT)

IoT has created a technological stir in the pharma industry with its seamless device integration, remote monitoring, smarts sensors, etc. This technology has also resulted in a paradigm shift in the software quality assurance process for the pharma manufacturing and delivery channels.

Be it usability, compatibility, cyber security, data privacy or performance testing, QA teams employ IoT-based new approaches to improve efficiency, accuracy, security, and productivity. Additionally, IoT testing plays a vital role in validating IoT integrations, operations and service delivery pertaining to the pharma sector.

Big data

Being a research-oriented and data-driven industry, most of the innovations in the pharma sector require the support of Big data. However, streamlining a massive amount of heterogeneous unstructured data can be both complicated and exhausting. So, this is how big data testing comes into the picture to ensure precision and better service delivery for the companies.

For the pharma sector, big data testing also makes sure that large volumes of data are analyzed, cleansed and integrated efficiently. With big data testing, businesses can optimize quality data management & deployment for a superior decision-making process.

However, this software testing process requires excellent understanding and tremendous technical expertise of advanced QA tools. Hence, instead of going ahead with big data testing in-house, pharma companies prefer to seek guidance from experienced technology assurance service providers.

Cloud computing

In the pharma sector, data collection and storage are areas where the importance of cloud technologies materialize. Be it clinical trials where volunteer registration across the globe needs to be managed on a real-time basis or the ever-changing drug compliance regulations of different countries; cloud services ensure smooth operations for pharmaceutical companies.

Avantgarde cloud-based software testing is also used for validating every process in the cloud, from cloud migration to cloud deployment and management. However, not every pharma business is well-versed with tools to ensure a smooth cloud migration or integration. This is where business assurance providers who are experts in every aspect of cloud testing contribute to making data management in pharma simpler.

Advanced analytics

The pharma sector primarily focuses on drug manufacturing, which is why patient data analysis is the key to every decision. In this regard, advanced data analytics help pharma companies get unique insights into any specialized drug’s effectiveness.

Such technology of advanced analytics also helps in quality assurance in the pharmaceutical industry. It eases the monitoring process with predictive analytics, data mining and forecasting. Furthermore, this advanced analytics aids QA testers in getting precise results during the quality engineering process.

AI-enabled services

The pharma sector has started taking baby steps towards implementing AI in pharmaceutical software. From identifying the right candidate in clinical trials to predicting an epidemic, AI & ML have brought about a transformational change in the pharma industry.

The quality engineering cycle in the pharma sector has also been hugely augmented by the capabilities of AI and ML algorithms in its software quality assurance process. AI-enabled testing in pharma has made the software testing process smarter and more efficient as it has removed bias and instilled full transparency into the system.

Moreover, using ML models, software testing facilitates effective drift detecting and monitoring of feedback loops. As a result, pharma companies can use such ML models to focus better on personalized treatment and digital therapeutics. However, not every pharma company possesses such specialized testing expertise, which requires seeking guidance from experienced software testing service providers.

The way ahead

Even with such emerging technologies on board, the pharma sector faces many challenges such as targeted drug delivery, super customized therapies and easy compliance. Most of these concerns can be addressed by proper implementation of technology into the quality assurance process. However, with a proper QE approach, businesses make these technologies more efficient and productive.

Qualitest provides advanced business and technology assurance services and uses the power of AI and Automation for faster and more accurate QE. Speak to an expert at Qualitest to improve the business processes at your pharma company.

quality engineering free assessment