Medical Device Quality for SYSPRO by uniPoint

Our suite of Quality & Continuous Improvement modules are designed to help your medical device company automate its journey toward excellence.

UniPoint provides a suite of quality and continuous improvement modules that are designed to help your company meet compliance, track, control and reduce costs of quality and maintenance with simple and intuitive software that will help you achieve excellence.

Product Groups
Our core Quality system is called the Quality Toolkit. It is comprised of the following bundle of modules:

• Non-Conformances
• Corrective Actions
• Preventative Actions
• Inspections
• Equipment & Tooling Maintenance
• Document Control FDA 21 CFR Part 11
• Customer Service
• Trend Analysis
• To-Do’s
• Key Indicators
• Tool Window Manager
• Advanced Reporting
• System Administration
• User Administration
• Auditing
• Education & Training
• Health & Safety
• Surveys
• Inspection

Non-Conformances

• Create Customer, Vendor, Internal Or Other Non-conformances, with life-cycle management, cost tracking and complete visibility at every NC Stage.
• Unique Accounting integration tab — for visibility to customer/vendor invoice or credit memo, and summary Cost of Quality information

Corrective/Preventative Actions

• Create/maintain CPA’s, linked back to NC or multiple NC’s
• Manage Life Cycle of CPA’s, with user security:
• CPA status automatically updates as process unfolds: Origination, Investigation, Action Plan, Verification
• Track Quality hrs/costs per CPA activity tab

Inspections

• Identify all the inspection criteria for every part: dimensions, tolerances, sample sizes, blueprint location.
• Create First Off, In-Process, Final Inspection process per part, and per Customer
• Print Inspection Reports, Deviation requests, and Charting/Graphing
• Store actual dimensions recorded in database
• Request/link to Non-Conformance
• Manage receiving inspection

Equipment/Tooling Maintenance

• Maintain a complete listing of all equipment by type: Tools Tooling, Machinery, Building Equipment, etc, or any company asset class
• Ability to categorize by maintenance by type, class, status, and create To-Do’s
• Store all planned maintenance tasks and record unplanned repairs
• Record multiple maintenance tasks per piece of equipment with unique frequencies for each maintenance task
• Track maintenance hrs and costs, predict equipment downtime, and view Maintenance Schedule by date range and other criteria
• Create a complete maintenance schedule by class, employee or individual piece of equipment

Document Control

• FDA 21 CFR Part 11 Compliant
• Track all Company Documents (grouped by type and category) in a master database.
• Ability to control document approval sources, and complete distribution lists on a per document basis
• Track status of documents (active, pending, obsolete)
• Tract document revision changes, and quickly copy old revisions to new revision, complete with existing approval and distribution lists
• Ability to search, list, find all company documents by status or distribution
• Ability to Link to actual document file path, or web page, and view document on-line
• Excellent tool for confirming status of documents and distributions during audits

Customer Service

• Manage all customer service issues (Complaints, Communications, etc.)
• Transform your quality analysis
• Reduce your quality cycle times
• Close items in a timely manner, and communicate resolution to your customer
• Consolidate correspondence centrally
• Integrate with existing Quality Info

Health & Safety

• Store, manage, and access all of your required employee health & safety records.
• Preserve your records, ensure compliance for an indefinite period of time, and avoid the potential for costly fines, citations or legal liability.

Additional Included Modules:

• Trend Analysis
• Auditing
• Education & Training
• Surveys
• To-Do List
• Tool Windows Manager