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Complaint & Corrective Action Software (CAPA) for Life Sciences

  • Life Sciences

Manage Complaints, CAPA, Adverse Events, Audits and Non-Conformances

i-Sight Quality and Corrective Action software enables FDA-regulated life sciences organizations to manage product complaints and corrective and preventive actions (CAPA) within a 21 CFR Part 11 compliant solution.

i-Sight Quality and Corrective Action software is ideal for medical device, pharmaceutical and biotechnology companies. As the leading complaint handling and corrective and preventive action management software , it provides the tools you need to meet regulatory requirements while improving products and processes.

i-Sight Complaint & Corrective Action software (CAPA) advantages:

  • Powerful and flexible: i-Sight can evolve as your operating environment changes
  • Customizable: i-Sight adapts to your terminology, workflow and procedures
  • Compliant: Secure application with complete audit trails and electronic signatures

i-Sight Quality and Corrective Action software is designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Additional measures such as document encryption and use of appropriate digital signature standards are employed to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.

Customer Story: Case Management Software for Medbuy

Canada's largest medical group purchasing organization, Medbuy, has implemented the i-Sight Complaints Management software package.

i-Sight enable’s Medbuy and its 300-plus member hospitals across Canada to reduce administrative expenses and increase the quality of patient care by providing a fast, efficient and cost-effective means of logging, tracking and resolving complaints arising from their purchases of pharmaceuticals.

Using i-Sight's leading-edge portal technology, pharmaceutical vendors will be notified automatically when hospital staff report errors in shipments, incorrect labelling, problems with packaging and other such problems. Vendor representatives will then be able to login to the portal and provide a resolution. At the same time, Medbuy, its hospital members and pharmaceutical vendors will benefit from real-time access to ongoing statistical information that will enable them to reduce the incidence of such problems in future.

Read the MedBuy Case Study Here.

Related Article: Valent BioSciences Chooses i-Sight Complaint Handling Software and Corrective Action Software
Feature List: i-Sight Case Management Software
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