“Transforming the conventional compliance system/processes to cloud-based quality management solution”
For life sciences companies, quality is not just a buzzword but a foundation upon which organizational success is built. It goes beyond the absence of defects, it is a commitment to precision, compliance, and the relentless pursuit of safety and efficacy in products and processes. In its essence, quality means delivering products and services that consistently meet or exceed the expectations of industry regulatory standards, customers, and patients. In this ever-evolving industry, understanding and embracing the true meaning of quality is a strategic imperative that paves the way for innovation, reliability, and the goal – of improving and safeguarding lives.
The need for more seamless end-user adoption and a more efficient QMS is NOW!
Life sciences operations like R&D, clinical trials, manufacturing, supply chain management, regulatory affairs, and IT operations, have a growing need for an improved Quality Management System (QMS). As companies adopt more contemporary strategies for quality management, regulators are highlighting the importance of incorporating quality metrics like compliant rate, on-time delivery, CAPA effectiveness, SOP Deviations, change control, Audit findings, and Regulatory & training compliance into daily operations. Companies have an inherent need for a quality-oriented problem-solving culture, which involves minimizing process variability and annual cost savings amounting to millions of dollars.
Challenges with traditional (or) conventional GxP Compliance management systems
· Documents are generally spread across multiple different EDMS programs.
· No defined SOPs/Processes for managing Quality documentation.
· Disconnected SharePoint libraries and sites.
· Quality documents usually exist in redundant files and several data formats.
· Challenges faced in the user adoption, access to individual files and their processes.
· Lack of a precise learning management system
· Differences in the Workflows & SOPs varied by sites & geographies.
The best approach to address this problem is by establishing consistency, standardization, alignment and bringing harmony in quality data and processes.
One platform, One data and One governance
Moving from disconnected legacy systems to the cloud is a mindset shift.
Every company in the life sciences industry will have its unique set of processes throughout its sites, labs, and offices across all the global divisions. Partners like us add value to standardize all quality documentation using a unified set of data and formats by eliminating several outdated in-house systems as well as traditional EDMS programs by bringing all of these under a unified cloud-based Quality solution.
The in-house content management competency includes special features such as collaborative authoring, use of templates, process navigator capabilities and designing enhanced periodic review workflows for the QMS will improve user experience and adoption.
Governance becomes simplified with data and documentation in one platform by making it easier to access and control the SOPs. This promises any organization to move business-critical flows and GxP process documentation on the unified platform to make systems validation implicit.
We at SMART IMS strongly believe and encourage the industry to focus on the idea of having one platform, one data and one governance. If your business comes from a digitally scattered ecosystem, join us in this quality revolution where we bring data, documents, workflows, CAPA (Corrective and Preventive Actions), and Risk management procedures all under a single cloud implementation.
This is just the beginning.
The value addition doesn’t stop by having you transition over to a cloud-based solution. It extends and includes consulting and professional services focused towards integrating multiple disciplines and verticals of your organizations. We also ensure a reduction in the response time of your user clientele to adapt to the new quality solution offered by our extensive end-user learning management system.
Partner with us and embark on this journey of revolution in regulatory and quality compliance. Connect with our experts today!
