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Capabilities Document Training CAPA Inspection Inventory

Planning

This module allows you to create reports and track any type of plan within your organization. It will ensure that all elements of a project are documented in one place.

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Change Control

This module allows you to create reports to track and approve any type of change to a product, process, or system. This will allow you to introduce these changes in a controlled and coordinated manner.

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Risk Management

This module allows you to create reports to conduct a systemic preventative approach to food safety from biological, chemical, and physical hazards in production (HACCP reports). It also allows you to create a structured analytical tool to identify and evaluate the potential failures of a process within your organization (PFMEA reports).

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4-Stage Approval

The documents module allows you to easily complete approvals from different users and departments for your controlled documents. With the use of an approval matrix, personnel and departments can be pre-assigned a task to approve one of the four stages.

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Revision Control

The documents module allows you to easily create new revisions while storing the previous obsolete version. When creating a new revision, the 4-stage approval process will begin again, and change control reports can be easily linked.

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Document Training Link

Users can also easily create training from a document, allowing them to access the resource material prior to completing the test or checklist.

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Audit Trail

All our modules have an audit trail built into them where you can see all activities completed or changes made to a specific report, who did them and when.

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Custom Test Builder

Easily create your own training tests with the click of a button.

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Employee Custom Grouping

Easily assign training and provide document access to users through employee groups.

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Employee Tracking and Analytics

Easily store employee information and training records to ensure everything is completed in a timely manner.

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Smart Onboarding Assignment

By adding users to their applicable employee group, the system will automatically suggest all applicable training and allow you to assign it with the click of a button.

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Custom CAPA Template Builder

Easily create your own quality event forms with our template builder or choose from our customizable CAPA templates.

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Corrective Action Reports

Corrective and Preventive Action is a process taken to eliminate causes of non-conformities and other undesirable situations. It is a set of actions required for GMP purposes to rectify an issue that must be addressed.

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Non-Conformance Reports

Non-Conformance is a process taken when there is a failure to meet the regular standards of a particular approved method.

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Deviations

A deviation report should be used when your operation is circumventing (either planned or unplanned) a regular process or procedure. This report is meant to help ensure that the deviation is safely handled with all risks considered.

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Compliants

A complaint report should be used when you receive a customer complaint to ensure that it is properly addressed.

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Out of Specifications

An out of specification report should be used when test results for your sample do not meet the established criteria.

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Custom Planning Template Builder

Easily create your own planning forms with our template builder, or choose from our customizable Planning templates.

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PFMEA

Process Failure Modes Effect Analysis, a structured analytical tool to identify and evaluate the potential failures of a process within your organization.

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HACCP

Hazard Analysis Critical Control Point, a systemic preventative approach to food safety from biological, chemical, and physical hazards in production.

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Workflow Designation & Automation

Assign each section of your quality event forms to personnel or departments. The following section will not be unlocked for editing until the previous section is completed.

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Report Triaging

Users can create a general CAPA submission form (or use our preset template), where the person responsible for form triage is the owner of the next section. From there, the user can escalate the submission to the appropriate form-type and close the submission report.

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Reason Codes

For added traceability, when major changes are made to the report (re-opening, editing, or closing), users are required to enter a reason code and their e-signature.

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Field, Section, Report Sign-Offs

Pre-determine which user or department is required to add their signature for various form elements, including fields, sections, and report closure.

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Custom Analytics

Customize your analytics by setting default views and creating copies of graphs with different default views.

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Supplier Quality Management

Ensure that your suppliers consistently deliver products that meet your standards and easily track any discrepancies with our CAPA module.

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Supplier Contribution Portal

Suppliers can directly enter necessary information through the supplier portal into your reports when identified as section owners.

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Cost of Quality Tracking

Track how much it will cost to ensure you deliver a quality product or service to your customers.

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CAPA Training Link

Users can also easily create training from a CAPA report, allowing them to complete the test or checklist.

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Custom Inspection Templates

Easily create your own inspection forms with our template builder.

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Audits

Create custom audit templates and fill in these templates with results when an audit is due. Isolocity makes this process easier by sending reminders when an audit is due.

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Receiving Inspection

This module allows you to record when raw materials are received from a supplier. Furthermore, it allows you to inspect them for quality purposes before they enter your facility.

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Equipment Inspection

Create custom equipment templates for various processes, including maintenance and calibration. Fill in these templates with results when these processes are due.

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Calibration

Create custom calibration templates and fill in these templates with results when equipment calibration is due. Isolocity makes this process easier by sending reminders when a calibration is due.

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Product Inspection

Complete finished product inspections for each batch to ensure that your product passes all the necessary quality checks. For products that do not pass easily, link to a CAPA report for added compliance.

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Location Inspection

Complete location inspections for different areas to ensure all the necessary quality checks are complete. For locations that do not pass easily, link a CAPA report for added compliance.

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Activity Inspection

Complete activity inspections for different processes, such as sanitation, to ensure that all necessary quality checks are complete. For processes that do not pass easily, link to a CAPA report for added compliance.

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Lab Results

Complete activity inspections for different processes, such as Lab Result verification, to ensure that all results are within specification. For results that do not pass, easily link an OOS report for added compliance.

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Planning Reports

This module allows you to create reports and track any type of plan within your organization. It will ensure that all elements of a project are documented in one place.

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Order Management

Easily track customer orders with Isolocity; the order number and details can easily be carried over into other modules, including product inspections and shipments.

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Shipping

Easily create records to track shipments of product by batch number. With the Inventory module add-on product quantities will also be automatically reduced.

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Byproduct Management

Easily track the production of any by-products created in your product development process. With the Inventory module add-on by-product quantities will also be automatically added.

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Specification Management

Easily create your own specifications with our template builder.

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Batch Record Creation

Isolocity will track the history of all batch numbers and what reports they are associated with. This can then all be easily exported as a PDF or CSV by the user.

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SPC Tracking

Isolocity will calculate the Statistical Process Control (SPC) for your different product production methods. This will be calculated based on the information entered in the Inspections module.

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Cost Tracking

Isolocity will be able to track your costs based on what has been previously entered in your database. This will include both fixed and variable costs.

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Time Tracking

Easily track the time spent on product, activity, or equipment inspections with the timesheet feature. With the cost-tracking add-on, these labour costs will be incorporated into the cost of the batch.

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Electronic Batch Records

Isolocity will track the history of all batch numbers and what reports they are associated with. This can then all be easily exported in a PDF or CSV by the user.

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CAPA

For processes that do not pass easily, link a CAPA report for added compliance.

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Inventory Tracking

Easily track any movement and inventory of products through electronic batch records. Isolocity will track the history of all batch numbers and what reports they are associated with.

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Inventory Cost Tracking

Easily track any inventory and cost of product through electronic batch records. Isolocity will track the history of all batch numbers and what reports it is associated with.

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Batch Location Tracking tick-green
Custom Batch Process Routing tick-green
Multi-Path Batch Process tick-green
Master Batch Records (MBR) tick-green
Master Batch Files (MBF) tick-green