Companies in the life science industry are helpful in improving the quality and standard of life. They have applications in health, agriculture, medicine, and the pharmaceutical and food science industries. The life science industry consists of many sub-sectors such as medical devices, biotech/pharma (including agro-biotech), diagnostics and even the healthcare IT (including telemedicine and bioinformatics).
The life science industry is a highly regulated industry. Companies have to comply with a myriad of rules and regulations across all aspects of their business.
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative. In that announcement, the FDA explained the Agency’s intent to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies. FDA encourages companies in the life science industry to implement modern quality systems and risk management approaches, to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).
In May of 2017, both the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulations (IVDR) entered into force. Although the FDA (USA) and the European Union take a leading role in defining the rules, local governments might sometimes demand slightly different or additional compliance requirements.
At Vivaldi Software we believe that every organization, small or large, deserves to have a highly-performing, user-friendly and above all GAMP5 & FDA compliant quality management system.
- Document Control (SOP’s, work instructions and other documentation)
Automate the everyday document management processes with built-in tools such as version control, the assessment & distribution workflow, digital archive and auditable history.
- Customer complaint, supplier complaints and internal deviations
Follow your complaints workflow process from initial registration through to final response. Manage customer resolution and ensure satisfaction.
- CAPA Management
Implement your corrective & preventative actions trough a compliant workflow process of plan, do and check.
- Incidents & Accidents
Vivaldi helps you to better track, investigate, and correct your EHS incidents to prevent or reduce the chance of recurrence.
- Risk management
Inventorize risks and embed risk management into your core Quality & EHS processes.
- Training and competencies
Manage all training data and in the central database of Vivaldi. Link competencies to training data, functions, roles and your staff.
- Management review and meetings
Centralize the records of your management reviews and meetings, including attachments and reports. Schedule and track linked corrective and preventative actions.
- Internal and external audits
Manage your internal & external audits. Ensuring your audit procedures are followed will enable confidence when facing any audits.
- Management of Change
Ensure that all documented changes are properly coordinated and executed. All related documents, CAPA's and activities are tracked.
Life science companies love Vivaldi Software.
Vivaldi Software has been developing Quality Management software and software for Regulatory compliance since 1995.
More than 75,000 users in the Biotech & Life sciences industry and other industries spread across more than 20 countries use our Quality Management Software on a daily basis
ISO 13485 Sessions - CAPA
In the ISO 13485 video series, Victor Wong from Vivaldi Software and Verlene Law from The Reg Consultants discuss the most important changes in the latest version of the ISO 13485 standard for the Medical Device Industry. In this video Verlene and Victor discuss the CAPA process.
ISO 13485 Sessions - Customer complaints
In the ISO 13485 video series, Victor Wong from Vivaldi Software and Verlene Law from The Reg Consultants discuss the most important changes in the latest version of the ISO 13485 standard for the Medical Device Industry. In this first video Verlene and Victor discuss the Customer Complaints.