C Cignus has more than two decades of experience in helping regulated industries streamline their quality business processes, establish electronic systems and manage compliance.
Whether you are moving from paper-based processes or implementing a new QMS, Cignus can help you select the best, most cost-effective enterprise QMS for your company. We provide industry best practices, standard templates and procedures for a rapid and effective implementation
Cignus Solutions dedicated team of industry experts and quality management professionals have more than two decades of experience developing and integrating enterprise QMS that lead to ISO Certification.
Cignus can accelerate the true Global Adoption process with effective roll out process to all sites across globe; create effective Video Training, local Work Instructions in different languages, site specific dashboards. We have a stock of predefined training materials, which will reengineered to suite the client needs.
We understand the differences in regulations and process variations for different functions in regulated space such as R&D, Biologics, Pharma, Commercial, CRO and can align to ISO 9001:2015, 13485:2016. We predefined processes that are compliant to industry specific regulations and aid rapid adoption.
In addition to our implementation division, our team of expert report developers and process engineers takes a holistic view on the reports usage and recommend effective techniques, design practices to maximize your return on investment. Cignus uses a proprietary report requirements collection template that ensures the reports’ quality and minimizes issues that interrupt data collection. We create Custom Dashboards, Trending Reports, and Operational Reports using Crystal Reports or Quality View tool to improve accessibility and provide crucial data when needed.
Our stock procedures and templates are prepared for specific functions in regulated space such as R&D, Biologics, Pharma, Commercial and CRO. Clients can purchase the complete set of procedures, templates and Forms for establishing QMS, standardization process or align to specific ISO guidelines. With the package, we will assign Customer Engagement Quality Expert for detailed walk through and can help in customizing according client specific needs
Our business process expertise includes in-depth knowledge of several key processes in QMS. Our process experts will identify and redesign processes and establish standardized workflows for Training, Change Control, Audit, CAPA, Supplier Quality and Complaints. Our procedure set shall include ISO compliant SIPOC and Process Flow Chart which will be utilized for QMS system design and implementation.
We have implementation experience with several small business CROs, R&D clients to EQMS Landscape. Our qualified consultants can analyze, design, and implement a paper and electronic QMS system according to your organization’s needs.
These are just a few of the following process improvement and tracking tools Cignus can create for your business: