Lean-Q Quality and Compliance Management Software
What's in Lean-Q
Lean-Q is a trusted brand for quality management software application. Lean-Q application has strong electronic capability of initiating, managing and controlling quality management investigations such as Deviation Reporting, Product Complaint Management, Change Control Management, Laboratory Out-of-Specification Investigation, Corrective and Preventive Actions all in one easy to use interface. Lean-Q also has the ability to raise interim report whenever necessary.
Lean-Q system automates identification, investigation, mitigation and prevention of high-risk events through integration and collaboration.
Lean-Q offers the best industry practices in quality management and uses the best in class integrated modules to measure and manage quality and compliance processes and execute organizational change.
- Six integrated investigation modules with sophisticated Administration panel
Product Complaint Management Change Control Management Laboratory Out of Specification Investigation Corrective and Preventive Actions
- Low cost and efficient software alternative for small and medium size GMP manufacturing enterprise
- Effortless installation for Windows Opearating systems. Just Download and use in the next minute
- FDA, 21 CFR Part 11 compliance for Electronic Signature and Electronic Records
- GMP compliant software with strong built-in validation rules
- Designed to comply with good documentation practices (GDP)
- Save time - save money - Less work. No more paper based quality investigations needed
- Electronic tracking, trending and reporting of quality investigations
- Intelligent software. Prompts to fill out every field and signature on a GMP record
- No workflow violation. Must have to complete, review, approve and close each investigation step by step
- Restricted privileges. Activity permission levels assigned and managed by system Administrators
- Step-by-step logical instruction workflow between administrator, entrylevel, reviewer and approver users
- No escape from accountability. Lean-Q has a built in Audit Trail and permanent activity history checks
- Increased visibility with realtime electronic signatures on the records and reports
- Huge data library. Capable of selecting data from every area of a GMP manufacturing site
- Data Integrity managed and controlled by the system Administrators
- User authentication controlled by the system Administrator
- Automated notifications to investigation Coordinators on every step of an investigation
- Lean-Q facilitates enhanced flexibility and communication between functional teams
- Module specific GMP reporting system. Can be used for reporting, analysis and trending of investigations
- Multi layers database security. Scheduled database backups multiple times per day
Lean-Q Software at a Glance:
Life science industries are regulated by government agencies like FDA and must be in compliant with regulatory guidelines like 21 CFR Part 11, Part 210-211, Part 820 / QSR, Part 606, ICH Q7A and ISO standard. Lean-Q software application has been designed and developed by a group of experts within the life science industries.
Lean-Q application has been dsigned to comply with electronic records and signature requirements for GMP documents, logical investigation workflow, continual data backups, user - reviewer - approver privileges, audit trail, activity history improved traceability and control of noncorformance and reporting CAPA.
Supporting Life Science Businesses
Lean-Q software application is specially built to support the quality management systems for small and medium size life science businesses. This include Pharmaceuticals, Bio Tech, Medical Devices, Animal Health, Food and Consumer Healthcare business.
While doing its job faster and better, Lean-Q can surely offer the cheapest solution for businesses who intend to transform themselves from traditional paper based systems to robust electronic application for the first time or businesses with existing electronic systems but sky high price to pay.
Lean-Q is highly cost competitive while works better than any other popular application.
Integrated Software Modules
Lean-Q offers electronic quality management solutions in the area of Deviation Management, Complaint Handling, Change Management, Laboratory Out-of-Specification Investigation and Corrective and Preventative Action. There are six separate modules integrated to run in one application.
Deviation Management The deviation management module is designed to initiate new deviation with deviation details, deviation assessment and investigation, root cause analysis, risk assessment, CAPA and final approval work flow. All modules have already built in report queries for generating reports in pdf format. Users can create, review and approve a new or existing recrods according to their privilege setup. Customer Complaint Handling The complaint management module is designed to initiate new complaint, customer and organization details, QA evaluation and investigation, CAPA and final approval work flow. Change Management The change management module is designed to initiate new change request and pre change impact assessment and post change approval work flow. Laboratory Out-of-Specification Investigation The laboratory OOS investigation module is designed to initiate new OOS investigation with out of specification information, initial investigation details and findings, determination of assignable cause, investigation measurements, resample/repeat/retest decision, final conclusion and approval work flow. Corrective and Preventative Action Lean-Q system has automated the initiation and tracking process of corrective and preventative actions and their execution from within each of the deviation, complaint, change control and OOS investigation module. Interim Report Lean-Q system has the capability to raise interim reports to reflect timely progression of the workflow. Administration Module Lean-Q application has separate virtual admin panel from where administrator can take control on creating users with specific privileges, editing users, master data management, can open a closed record for further editing.
Segregation of Duties
Lean-Q system has been developed with clear segregation of the duties between the function al teams. All Works flow seemlessly between the administrator, common users and users with Managerial capacity. Common users can access and create new documents while user group with managerial authority can create as well as review and approve the tasks.
Streamline Quality Management Activities
The aim of designing Lean-Q system is to reduce and eliminate tons of traditional paper based documents generated by Quality departments by integrating the most practiced quality activities into a single electronic application interface. Data entry and investigation process is fast in Lean-Q through interactive task flow sections. The application has automated the communication system among the multi functional groups.
Lean-Q application can be customizable on request according to individual business need. Customization order would ask for onetime development pricing depending on the level of customization.
Lean-Q team offers continual support to customers and guarantees a long term professional and successful relationship.