Vigisoft - solution

By: Vigisoft  05/12/2011
Keywords: Quality Management

QMSVigisoft provides an integrated solution to help you to organise and document the actions of people, processes and technology in support of your business strategy and in preparation for any necessary regulatory activities in the form of audits and inspections.

It is implemented to support strategic quality management programmes and to provide confidence in your operational integrity by the consistent application of business rules within your organization or business unit.

In addition, it  provides an integrated, on-line, quality operations manual for quality systems management and regulatory compliance


  • Single enterprise-wide repository accessible to all QMS users
  • Improved adherence to Company quality policies, standards and processes
  • Maximum transparency of the QMS for management and audit purposes
  • Version controlled, secure access providing information on a need to know basis
  • Ability to author, review, approve QMS content in a virtual environment
  • Supports closed-loop activity chain for quality non-conformances
  • Time stamped audit trail or all QMS activities
  • Audit management and reporting enables compliance
  • Timely QMS updates following changes in regulatory or quality requirements
  • Improvements in consistency across quality systems implementation and associated procedures/ SOPs
  • Integration with legacy systems, standard COTS systems and across multiple lines of business.
  • Clearly articulated strategy and goals, communicated across the enterprise
  • Improved business alignment through monitoring of  KPI’s


  • Clearly identifies QMS processes
  • Identifies and categorises the documents needed to produce a fully compliant and effective QMS
  • Documents are interlinked providing ease of navigation
  • Documents are held as accessible, searchable records in one place
  • Responsibility and accountability for each activity defined using the RACI model
  • Determines operational and monitoring criteria and methods
  • Provides for planned results and continual improvement
  • Enhances informational flow and facilitates operational feedback
  • Is a powerful motivational presence within the organisation

Manage individual and team member’s workload. Manage multiple tasks and priorities, communicate and delegate effectively, and use an organized planning process.


  • Gain competitive advantage through increased effectiveness and productivity
  • improved personal self management and team performance
  • Increased control
  • Less stress
  • 20:20 memory
  • overview of team's workload from a single source
  • Consistent focus on priorities

Track documents and changes and alert appropriate users when action is required.


  • Enables content to be routed through pre-defined processes to predefined users
  • Ensures that formal process review is recorded
  • Stores reviewers comments
  • Maintains a status held against each QMS content
  • Ensures all reviewers have reviewed object before it can be approved
  • Workflow permissions can be assigned to roles, user groups or users to enable the authorization process
  • Provides standard messages that can be used or modified
  • “Read and understood” electronic signature

Manage, deliver and control documents which are critical to the creation of business value.


  • time based view of the QMS
  • search facility to see if object already exists
  • procedures supports hierarchical inheritance checks
  • if object is changed at one level of the QMS it is changed at all other levels and activities in which it is used
  • supports different status for QMS content together with complete audit trail from initiation to retirement
  • supports the publication of approved content prior to it becoming effective
  • supports versioning of change made to content, activities and roles during the review and approval cycle
  • automatic version numbering
  • user can restrict content, activities and role information to what is directly relevant to them
  • can hold multiple version of objects, documents and activities and their associated content
  • can restore a previously archived object or content

Review and assurance activities are an integral part of the QMS. Provide assurance that process performance and product quality are managed over a lifecycle and that the QMS is working as designed and that Users are following prescribed procedures.


  • develops and maintains assurance plans at strategic and operational levels
  • measures assurance performance against plans at all levels of the QMS
  • supports paperless assurance file reviews and approvals
  • electronic sign off of assurance activities
  • automatic alerts for past due dates
  • full version control for all assurance reports
  • identification of appropriate actions and outcomes from assurance activities
  • automatic recording of non conformances and risk within the CAPA module
  • integrates with project management COTS tools
  • advanced reports

Closed-loop corrective action for tracks non-conformance or deviation from the standards and procedures in the quality system. Recurring issues are investigated, root causes identified, corrective/preventive action implemented and evaluated for effectiveness.


  • forces a risk assessment for every CAPA
  • can record more than one risk per non conformance
  • records minutes of risk meetings, risk scenarios and risks identified
  • allows the slicing and dicing of data for individual needs
  • supports user defined workflows for risk and non conformance activities
  • maintains records for every change to the risk activity
  • provides alerts to users of new and modified risks
  • provides time based reports under various headings
  • root cause analyses

Ensure that Policies and Strategy are actually implemented, and that required Processes are correctly followed.

This includes defining Roles and Responsibilities for every activity using the RACI model (responsible/accountable/ consulted/ informed) and assigning these to individuals and teams within the QMS


  • provides strategic direction
  • defines and documents roles and responsibilities
  • ensures that objectives are achieved
  • ensures compliance

Provide improved adherence to company standard operating procedures and  in the overall consistency across QMS implementation by achieving uniformity of the performance of specific functions.


  • timely updates to SOP's following changes in regulatory or quality requirements
  • supports versioning of changes and provides automatic version numbering
  • recipient can indicate that they have “read and understood” content via electronic signature
  • ensures that formal review of SOP's is completed and recorded
  • a User search for a specific SOP shows the identified Procedure together with all related information, this enable Users to navigate the QMS with ease and view and understand all aspects of their activities

Plan and execute audit activities, record findings and conduct appropriate follow-up actions, and track trends based on audit results. It is suitable for management and control of a wide variety of audit processes.


  • can create and manage different audit categories
  • creates and manages items for audit
  • links non conformances to the audit
  • improves follow up and action resulting from audit
  • provides a complete audit trail and facilitates compliance with industry standards and regulatory requirements

Monitor, measure and analyse information in real time. Decision makers can proactively track, monitor and respond to up to date key performance indicators


  • out of the box standard and ad hoc reports
  • users can personalise and customise dashboard
  • Users can create/modify new metrics
  • Users can drill down, set alert thresholds
  • Users can assign tasks themselves

Keywords: Quality Management

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