Origin

Document Control, Change Control, Employee Training

Origin is an integrated Quality Management System, focused on the integration of three core quality processes – document control, change control and employee training.

In a regulated environment, documents are controlled through the Documentation Center, which is at the heart of the quality unit. The Change Control module manages Change Requests and assigned action items which, on many occasions, require creation of new documents or the update of existing ones.

Employee training and certification requirements are linked to job descriptions and are managed by training supervisors. When a new version of a policy or procedure is issued, relevant employees are notified. Once trained, their training records are updated accordingly.

Origin provides comprehensive management of ▪ Documentation Center ▪ Change Control Process ▪ Regulatory Affairs submissions ▪ GMP training and Employee certifications ▪ Documentation archives ▪ Publishing policies and procedures on the company's Intranet site.

Documentation Center Module features:

• Control of the document life cycle - creation, review, approval and publication
• Linking of documents to products and systems
• Management of linked documents that need to be updated concurrently
• Facilitation of the review cycle of the document
• Mailing list management - predefinition of a group to be automatically notified about any status change of the document
• Management of the organization's documentation archives
• Extensive document search capabilities
• Diverse reports to assist management of the Documentation Center

Change Control Process Module features:

• Electronic Change Requests
• Support of temporary and permanent changes
• Tracking of tasks, responsibilities and due dates of the Change Control
• Linking of Change Control to QA documents
• Management of the Change Request approval process
• Tracing of document updating as a result of the CCP
• Viewing of CCPs by Change approvers on the Intranet
• Viewing of employee tasks on the Intranet

Regulatory Affairs Submission Module features: 

• Management of Regulatory Affairs (RA) submissions
• Control of versions and notifications of submissions
• Tracking changes of documents within a specific submission
• Tracking changes of submission versions
• Extensive submission search capabilities
• Diverse reports to control the RA submissions

GMP Training and Certification Module features: 

• Enable training supervisors to manage employee training requirements
• Training lists assigned according to job descriptions
• Electronic signature approval of employee-reported training
• Automatic creation of training tasks when new documents are issued
• Management of periodic document reading
• Publishing of employee training tasks to the company Intranet
• Diverse reports to track employee training and certification status

Origin Portal features:

• Easy and user friendly interface to end users
• Availability of information to everyone from everywhere
• Search and view of QA documents
• Printing of department procedures list
• Addition of watermarks and disclaimers to published documents
• Enables use of documents for training prior to their effective date
• New Change Control Requests can be opened (for any change)
• Enables users to initiate a request for a new document or a new version (Document Change Request)
• View of the status of in-process documents
• Viewing and approval of new documents
• Viewing of new Change Control and provision of feedback
• View of Change Control related tasks
• View of training list and current training requirements

Full 21 CFR Part 11 compliance 

• High level of security and authorizations, password management, automatic lock
• Full audit trail

The system's main features are:

• Comprehensive Documentation Center Management (SOPs, Policies, Forms, Validation Docs, etc.)

• Origin Portal allows easy and user friendly interaction with the Documentation Center - publication of new documents, document search, document for training, department indexes, and more.

• Controls the document life cycle - creation, review, approval and publication.

• Manages the organization's documentation archives.

• Publishing of documents to the company Intranet site in Adobe Acrobat format (pdf) .

• Publishing of departmental document indexes.

• Facilitates the review cycle of the document.

• Extensive document search capabilities.

• Manage SOP training records including electronic signatures.

• Competence of personnel - determine and manage necessary employee competencies.

• Maintain records of training, education, skills and professional experience.

• GxP training management including electronic signatures.

• Change Control management including electronic signatures.

• Full 21 CFR Part 11 compliance.

• Validation Kit included.