Maintain, Conduct and Manage Quality Processes in Your Natural Working Environment

Generica QMS solutions for Life Sciences Quality Compliance allow the quality team participants, managers, quality leaders, auditors, auditees, and outside consultants to maintain, conduct and manage quality processes in the natural working environment where they are the most comfortable– Email, MS Word, and MS Excel.
Generica QMS effectively incorporates the direct participation of all parties, including auditors, auditees and managers, into the entire process – from periodic assessment, through quality audits planning and audit conducting, all the way to remediation and, tracking audits results (observations and CAPAs).
Generica QMS turn inspections management, MOHs and customers, into an effective and easy process, where every critical inspection observation reviewed, checked, fixed and estimated at the site and corporate level. Finally, corporate, sites and external inspection became a one holistic quality operation.

 

List of Modules

• Quality Audit Management
• Internal Quality Audits
• External Quality Audits
• Auditors Management
• Suppliers Management
• Pharmaceuticals Co-Vigilance Audit
• Regulatory Inspection
• Risk Assessment & Trend Analysis
• Deviation & CAPA Management
• Change Control

Some Generica QMS customers use a single module, several use several modules and some use the full solution.

 

Features

Electronic Smart Objects

Generica QMS is based on KCS’ “Electronic Smart Objects” technology that enables users to convert “dumb” text into Smart Objects within the original Word, Excel, PDF or Email document. All quality management features and capabilities can be executed from the document or from the central management system. Generica QMS allows users to create, update, sign and receive quality auditing components (observations, audit overview, CAPAs, controls and other “micro content”) directly from the document. This capability reduces overhead, saves time, helps avoiding mistakes, and ensures that the management snapshot is always up-to-date.

 

Flexibility – An Off-of-the Shelf Product with Tailor Made Customization

Generica QMS allows for a quick and easy tailoring of its processes which results in both short and long term savings. Generica QMS produces an individual solution for each customer that still retains the requested QMS features. You can support existing processes or install a completely new system – Generica QMS allows you to use your legacy system, while smoothly transitioning to Generica QMS. Implementations are conducted by highly experienced and professional teams, including leading advisory services firms that analyze the organization processes and needs, recommend improvements, and implement accordingly.

 

Adaptability – Manage any Quality Compliance or GRC Processes on a Global Basis

Life Science customers typically expand the use of KCS’ solutions to cover most of their quality compliance challenges. Generica QMS can address other core processes such as SOX management, ERM, internal audit, security assessment and contracts management. KCS’ solutions can be used locally or across a global organization. This means significant savings on hardware and software costs, IT overhead, operational simplicity, training, and updates.

 

Quick and Easy Customization and Deployment

The entire customization process is completed while using minimal time and resources from you and your team. We employ an iterative-prototyping process, in which most of the work is done off-site, on our server. After only two or three iterations, the design is complete and we are ready to  install on-site, deploy, train and launch.

 

Audit Preparation and Execution with Checklist and Audit History

Generica QMS provides the use of databases with both universal controls (FDA, CE) as well as internal SOP controls for conducting your audits. With Generica QMS, every quality step starts with historical content (past observations, inspections, etc.) and up-to-date checklists. This feature ensures that you cover all your past fails and requested areas.

 

Why you should use Generica QMS

Easy Deployment

• Short and easy learning curve – no need to navigate unfamiliar sequences of pre-defined UI screens
• Saves time and money on training of employees and consultants

Ease of Use

• Conduct and manage quality processes in the natural working environment where they are the most comfortable– Email, MS Word, and MS Excel
• No duplication of efforts – all notes, reviews, procedures, responses, and reports can be done within the original documents
• Maintain process document templates for any key organizational process that allow for one-click inclusion of all up-to-date risks

Strong Tracking and Reporting Capabilities

• Audit project progress and results can be easily tracked in real time
• All relevant portions of an audit report are automatically sent to the relevant manager
• Generica QMS allows annual project planning, resource allocation and budget Vs. actual reporting
• Generica QMS ensures that all associated organizational risks are properly included as part of the planning and documentation of the process
• Generica QMS ensures resolution of findings, deficiencies, etc.
• Simple tracking of response status
• Significant reduction in project completion time