In this second post, we focus on the life sciences space where ComplianceQuest has deep expertise from a quality and compliance perspective.
Over the last few years, we’ve worked with close to 100 enterprises in the life sciences space serving users in over 800 locations around the world. We’ve played a key role in automating various quality and compliance processes including document management, audit management, CAPA, complaints, risk, supplier and training.
From medical device and pharma companies to emerging biotech inventors and digital health startups, we’ve served a range of clients including startups, SMBs and Fortune 1000 firms.
The Macro Trends
Our experience in this space has helped us spot the following big trends in Life Sciences:
- Unlike in many other sectors, regulatory compliance (FDA 21 CFR Part 11, FDA Software Validation, ISO 13485, PMDA, TGA, for example) is a dominant factor for success. In fact, winning on compliance can act as a game-changer.
- According to a study by Deloitte, historically, life sciences companies have carefully tracked risk metrics of compliance parameters based on current data. But with the advent of AI & Data Analytics, the role of predictive analytics in compliance risk mitigation is going mainstream.
- The market for Software as a Medical Device (SaMD) is growing tremendously and these software-first companies have to get used to the process of regulatory approvals & other compliance-related processes.
- Strong and proven supply chain capabilities, with clear supplier metrics is more crucial than ever, especially with global supplier partners.
- Closely tracking variations of regulatory frameworks in multiple geographies is a key challenge.
- Life Sciences companies need different EQMS solutions in different stages of their journey. In the pre-approval phase, document, audit, inspection require greater emphasis, and post-approval, one needs greater focus on supplier, complaint management, training, etc.
- The upcoming implementation of the Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) will be game-changers for this industry
- And finally, life sciences companies will have to over-focus on quality and compliance processes not only to meet necessary regulations but to derive significant competitive advantages in terms of quality, efficiency, brand and speed.
The Role of an EQMS in Life Sciences
Even as these trends become a reality, what is the fundamental role of an EQMS from a quality leader perspective? The quality leader is looking at deriving the following impact from using an EQMS:
- Ease of Implementation & Data Migration
- Drive Efficiency & Automate key quality and compliance processes
- Scalable solution, as the business needs/scale of operations change
An EQMS like ComplianceQuest built and run on the Salesforce.com platform will work with quality leaders to deliver the following experience:
- Kickstart digital transformation of quality and compliance with a set of solutions relevant for your context. For example, a life sciences startup in the approval phase will focus on document, inspection and audit processes. In the scale stage, one may focus more on complaints, risk and supplier solutions. A cloud-based, customizable solution like CQ can make this happen with ease.
- Ensure the EQMS integrates with your other software systems, ensuring seamless flow of data across the “supplier-internal processes-customer” lifecycle.
- Safety is one of the most crucial aspects in life sciences, arguably much more than most other industries. Your EQMS must be well-equipped to ensure all safety-critical metrics are tracked through a custom dashboard & reports.
- Rapid innovation is now a constant in life sciences and companies have to keep pace with emerging technology and regulatory changes. Predictive analytics using key data points tracked on an EQMS are extremely critical.
- An EQMS can play a pivotal role as companies gear up for new product launches, ensuring quality and compliance parameters don’t delay the release date.
- The CQ EQMS can help life sciences companies with a range of solutions including audit management, change, CAPA, document control, equipment management, to name a few.
Overall, a real-cloud based EQMS drives efficiency and productivity while reducing complexity of operations, in a sector that is seeing rapid change, innovation and progress.
Request a demo and we can share more insights of how ComplianceQuest has delivered digital transformation and automation for several life sciences ventures around the world.
Write to us at firstname.lastname@example.org for a demo.