Manage and control documents created in any Microsoft Office or other application – policies, procedures, plans, instructions, etc.  Paradigm 3 is designed around the requirements of ISO 9001 from which most other document control systems are derived.  Paradigm 3 is the third generation product by Paradigm Software.  We have continually refined and improved our control of documentation systems over a 15 year period with excess of 1,500 independent auditors worldwide that have approved the methodology.

Suitable for Quality, Environmental, Occupational Health and Safety, Laboratory, Pharmaceutical, etc. management systems.

• Manage on-line editing, reviews and electronic approval
• Manage on-line versioning (Major, Medium and Minor)
• Maintains automatic versioning history of transaction for audit trail
• Automated document updating of insert fields with versioning information like version, authoriser, version dates and many more (Microsoft Word & Excel)
• Tree view folder structures with security controls on viewing, modify, printing etc.
• Automated review schedules that notify staff when review is due
• Document statuses available

Draft: place security behind who can edit Drafts

Current: assign control behind who can convert to Current

Pending: approve the document any time but set the convert to Current for a date in the future

Review: allow others to review a document before making Current

Ready: change to Ready status to let other know you have done your changes

Obsolete: all old versions retained and available and control who can view

Collaborate: used for multiple user to develop a document

Open: used when the document or form is to be completed

Completed: used to lock an open form

Manage and control electronic forms and checklists created in any Microsoft Office or other application. There are two components to electronic forms and checklists. 

1. Document control of the form or checklist. This component ensures the end users are using the latest approved version of a form or checklist.  Forms and checklists are imported into Paradigm 3 and approved as a controlled document.  (Also see Control of documents – at a glance.)
2. From the approved Current version electronic copies are made for data entry.  Copies have Open status and are locked as read only when converted to Completed. Completed forms and checklists become supporting evidence. 

• Manage on-line editing, reviews and electronic approval of master forms or checklists
• Control data entry into electronic copies
• Control who can edit and the location of electronic copies
• Automatically maintains history for audit trail 

Typical uses: 

• Meeting minutes
• Internal audits
• Forms and checklists that only one person completes from start to finish – (for records that require multiple personnel input refer to Control of records – at a glance)
• Forms that are designed in Microsoft Excel or Word
• Testing or validation forms
• Processing records

Manage and control electronic improvements that have a staged sign off, or require multiple staff input to complete.  As each page is completed, the next person in the chain is notified until all sections are completed.

• Design the fields and layout to be completed on each page
• Assign defaults on who is responsible for completing each page
• Track progress
• Import data by linking to external sources
• Set mandatory fields
• Construct pull down menu’s
• Add formulas to automate calculations

Typical applications are:

• Risk assessments
• Corrective Action processing
• Non conformances
• Change control
• Accident and incident processing

Manage and control electronic records from one to several pages long.  Place schedules behind each record to notify who is responsible for maintaining the record from time to time.

• Design the fields and layout to be completed on each page
• Assign defaults on who is responsible
• Import data by linking to external sources
• Set triggers to automatically notify someone when a set criteria has changed
• Set mandatory fields
• Construct pull-down menus
• Add formulas to automate calculations

Typical applications are for anything that needs maintaining, reminders to do something or where, if a change occurs, another activity is triggered.

• Maintenance schedules, each with different activities
• Calibration activities where single or multiple schedules are required
• Equipment list and asset list control
• When a field changes in the record, triggers a notification to alert someone – supplier rating change for example.

• Manage and control all training records.
• Link training records against a document.
• Set-up on-line training competency tests against a document or group of documents.
• Maintain staff qualifications, licenses and skills.
• Design the fields and layout of the training records required.
• Staff can be automatically notified for re training when a document is updated
• Set up your own user competency tests
• Keep track of training status
• Set schedules for retraining
• Assign defaults on who is responsible to trainers and trainees
• Set triggers to automatically notify someone when a set criteria has changed
• Set mandatory fields
• Construct pull down menus
• Add formulas for automatic calculations

Typical applications are:

Many compliance standards demand evidence that staff have been trained to use equipment or training in a procedure or instruction. Paradigm 3 displays this information at the document level and from a global perspective. Training records can be linked to an improvement item or a document.

An integral part of a management system is the proof of evidence to support the policies, and procedures and instructions.  Paradigm 3 provides tools to easily manage the proof and evidence defined in your management system.

• All modules have an inbuilt history record of activities associated with any item created in the system. 
• Users are issued notifications called Action Items. Action Items instruct the users on what is required – review a document, approve a document or investigate a non conformance. As users complete the task requested, the Action Item is locked, dated and time stamped and retained in the system as evidence. Most importantly, since this is a closed loop system, retrieval of Action Item history is done by simply selecting the item in question and listing the related Action Items. In effect, the notification system also doubles as the management system evidence.  
• Paradigm 3 has the added power to convert items in the Documentation Module to Evidence. For example, an externally created report can be imported and status changed to Evidence. From that point on, the report can be read but not modified. Typical examples are, validation reports, external audits, meeting minutes, completed forms. The user electronically prepares the items using the editing facility and then when satisfactory, converts the items to Evidence status which means no further versioning is possible.

A key part to maintaining a successful management system is the ability to involve everybody, disseminate responsibilities and keep track of progress. Paradigm 3 does this by issuing notifications called Action Items.  Paradigm 3 automatically sorts out each person’s tasks as events in the system occur and keeps everybody informed of their obligations at the desk top.

Typical examples are:

• Action Item to inform key personnel that a document has been revised and a new version is now available. Recipients are asked to acknowledge reading and understanding the new version.
• Action Item to inform the recipient that an item is due for review because no versioning has occurred within the prescribed period. Recipient can review on-line and if no changes are required, complete the Action Item as evidence that a review has occurred.
• Action Item to investigate a corrective action required from an audit or product failure
• Action Item to conduct maintenance or calibrate equipment

Action Items instructions and behavior are customisable, so system administrators can design an Action Item:

• as a notification only
• requiring completion within a certain period
• by writing the notification instructions in your industry terminology
• with an acknowledgement pull down list where one choice is mandatory
• to trigger a corresponding follow on Action Item when an acknowledgement pull down choice is selected
• to escalation if not completed within the required time.

In effect, the requirements of your management system are satisfied if everybody is on top of their Action Items.

Paradigm 3 has the flexibility to apply multiple schedules to any item in any module. Schedules are linked to the notification system (Action Items) and are issued to staff to complete a task. A common use for schedules is to remind someone that a check needs to be performed at a routine frequency, like calibrating an instrument or routine maintenance on machinery.  

In a management system schedules play a big part. To guarantee consistency and assurance, schedules can apply to holding regular meetings, maintaining a document review system, managing an audit program or keeping on top of regular tasks that have been written into the company documentation. Schedules can be applied to a document to manage the document or to manage a task defined within the document. 

For example: 

• A document should be reviewed at appropriate internals to maintain accuracy. This could be an annual review schedule to the document writer to review the contents.
• However, the same document may also be the company procedure for managing Safety Meetings and nominates that a meeting is to be held bimonthly. In this instance, a Safety Meeting bi monthly schedule is also applied to the document, but this time a notification issues to the nominated meeting coordinator. 

Typical uses are: 

• Scheduling meetings
• Managing auditing schedules
• Managing machinery maintenance
• Managing equipment
• Reviewing system records
• Managing supplier reviews

Paradigm 3 can be easily configured so that users know what they are responsible for in the management system. Responsibilities such as what documents they have been assigned to review, what equipment they are to maintain or calibrate, which record item they must maintain or review, what steps in the corrective action system they need to complete, etc.

By setting up Roles in the management structure, each folder or item properties are set up with which job title is the item writer, subject expert, reviewer, data entry etc. This defines the responsibilities, then, by configuring the system securities, authorities to view, print, edit etc. are defined. The combination of responsibilities and authorities defines your management system.

How a user interacts with Paradigm 3 is communicated via the Work Management Processor® screen which then automatically displays the user’s notifications and what they have responsibility for. Through the Work Management Processor® the user is able to look at the management system from the perspective of the position they hold within the company.

Paradigm 3 has the most effective and advanced cross referencing system available. The main advantage is that once the link is set it automatically synchronises with changes as they occur. If a link from a policy to the related procedure has a name change or is moved to another folder, the link moves with it. It is also possible to link the document to all the other modules in Paradigm 3. Link a document to the calibration folders in the Records Module so that users can read the document and then open the associated record. To maintain total system document and record management, Para-Links® also ensure users are shown the most recent document or item as each item.

Para-Link® is a truly dynamic cross referencing system across all modules that constantly updates and adjusts in real time.

The added linking functionality is users can also use the Para-Link® tool to go to the linked item ready for data entry or processing as appropriate. For example, users can start with the policy document, open the link to the procedure, read the procedure and then open the link to the form or records they need to complete as per the procedure. This feature is more intuitive than search and find, since the user can drill down the thread without returning back to start processing activities.

Typical applications are:

• Linking policy manuals to each associated procedure. Then link the procedure to the associated forms or records.
• Link a piece of equipment in the Records Module to an instruction in the Documentation Module and therefore ensuring the user always sees the current instruction.
• Link a procedure to a folder that contains all the records relating to the procedure that way making internal audits and external audits a breeze.