Facility information includes management system boundaries (e.g. number of facilities), addresses, management system scheme (e.g. single site, multi-site or campus), and scope of management system.
Interaction of processes allows the user to determine the flow of their processes within their specific type of scheme (e.g. single site, multi-site or campus).
Organization Chart and responsibilities allows user to identify all positions / job functions within the company and the applicable competence criteria. Users can also determine type of access to the management system and who has responsibility / approval access over each position.
Document controls allow for online storage of your documentation. A Master List will be generated and maintained appropriately with user permissions and ability to revise documents.
Relevant Issues allow users to identify and address internal, external, interested party and statutory / regulatory issues.
Risks and opportunities allow users the ability to identify potential risks and opportunities, evaluate them in accordance with Failure Mode Effects Analysis (FMEA) and take actions to reduce or mitigate the risks identified.
Objectives are established to show continual improvement of the management system. Objectives can be created by the user or based on action items determined from risks and opportunities. Objectives identify responsible personnel, timeframes and monitoring frequencies.
Create a training matrix that covers all personnel and required training topics, positions. Track training due dates and verify who is qualified to work independently on a task and who is able to train others.
Establish communication requirements for internal, external, interested party and statutory & regulatory concerns through the creation of a communication log. With the module, you can also identify and track any customer complaints effectively.
Establish vendor approval requirements, customize a vendor approval questionnaire and select the vendor approval frequency. Maintain your approved vendors through the Approved Vendor List.
Establish types of inspections checklists, inspection frequencies and responsible persons for implementing and monitoring facility inspection checklists, maintenance logs and calibration logs.
Identify and evaluate nonconforming product through a quarantine log. The quarantine log allows you to identify the material, reason for quarantine, who identified it, date removed from quarantine, actions taken, if a corrective action is required and who approved the actions taken.
Establish your internal audit system though an internal audit schedule, internal audit plans, use of internal audit notes and an internal audit report.
Easily tracks your nonconformances. Identified nonconformances are automatically put into the corrective action process. Establish timeframes and responsibilities for completing corrective actions. Document corrective actions on the CAP Form and monitor them on the CAPA log.
Easily complete your management review. The Management Review Report includes all necessary inputs and outputs and allows you to record the outcome / decision, required actions, responsible person and due date. All action items can be monitored through the summary
Record changes on the Management of Change Request Form and monitor them through the Management of Change Log.