Generica QMS is used for managing company regulatory inspections, including Internal Regulatory Inspections (MOH), Customers Inspections and Other companies Inspections. The Corporate Regulatory Inspections module can be implemented as an independent solution or as an additional and integrated quality audits module.

Generica QMS regulatory inspection solution ensures that all inspections are always reviewed, tested and fixed across all the corporate sites. Managing inspections with Generica QMS improves quality and reduce risk by helping to avoid repeat observations and focusing quality activity where the regulators are focused. With Generica QMS inspection, company audits are done more efficient and more effective.

Regulatory Inspection in Your Natural Working Environment

The product brings Quality Compliance Audit Management functionality right into users’ natural working environment – MS Word, MS Excel, PDF and email, and increases user productivity while helping to ensure FDA Quality Compliance. Generica QMS includes pre-defined solution and best practice, but it can be customized to the company processes and needs.

Unlike other Quality audit solutions, Generica QMS does not require companies to make expensive shifts into new environments and does not require the employees to turn away from their natural environments in order to use Quality Audit System.

Features

To achieve full coverage of Regulatory Inspection, the following functionality is covered:

• Semi-automatic inspection document uploading (PDF, HTML, Excel)
• Inspections and Inspections observations management
• New inspections observations rollout and sharing
• End-to-End Gap Analysis – Review, Test, Fixed and Confirm
• Inspectors management
• Audit preparation based on past inspections
• Full search, statistic and trends
• Management dashboards & graphs (Management, Auditors, Site QA head)
• Periodic reports
• Powerful and flexible permissions