Click on a question below to see the answer provided.
- Which DB Platform is appropriate for my needs?
- Can ProCalV5 be used on an enterprise level as well as by a single user?
- Can ProCalV5 be integrated with other software systems already in place (i.e. CMMS, Document Management, SAP, etc.)?
- Does Prime Technologies operate under an established and proven Quality System?
- Is Prime Technologies open to being audited?
- Is the ProCalV5 Calibration Management Solution 21 CFR - Part 11Compliant?
- What other companies are using ProCalV5?
- Is a ProCal V5 Installation Validatable?
- How does Prime Technologies help make validation of ProCalV5 easier?
- What support services does Prime Technologies offer?
- Does ProCalV5 provide Access Level Security by User? By Group? Are User Group Access Levels customizable?
- Does ProCalV5 support hierarchical relationships between equipment, instruments, loops & systems?
- Can I transfer my existing Calibration Data into ProCalV5?
- Can I use ProCalV5 to automatically schedule my calibration and PM events?
- Will ProCalV5 track ‘As-Found’ and ‘As-Left’ data?
- Can I reference my existing and/or new SOP’s to my calibration records in ProCalV5?
- Can I get ProCalV5 to provide forms & reports that look like my existing forms & reports?
- Does ProCalV5 have optional modules? What are they?
- Which documenting calibrators are supported by ProCalV5?
- How can I use ProCalV5 to capture my calibration data real-time, at the various locations where the calibrations are performed and still maintain the integrity and security of a central database?
- How do I get my organization trained to implement and use ProCalV5?
- How much does ProCalV5 cost?
- If I buy a smaller system, can I upgrade it later to a more robust platform and/or additional user licenses?
- Does Prime Technologies offer optional software support packages? What do they include / cover?
- Can I upgrade my existing ProCalV5 data to that of a newer ProCalV5release?
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Which DB Platform is appropriate for my needs?
- MS Access will slow down as the size of the DB increases and is best suited for smaller systems with limited or no need to keep an audit trail. There are no hard and fast rules, but the quantity and the number of users, number of instruments and the keeping of audit trail records influence rate the of records generated. Consult your QA representative for direction on the use of MS Access in a validated system. Least expensive ProCalV5 product initial cost. Archiving will probably be necessary for large databases and especially for large databases with the Audit Trail turned on.
MS SQL Server is a cost-effective route to an enterprise level DB solution, consult your IT professional for specific direction your facility may have for database selection and infrastructure implementation. Suitable for large databases including extensive Audit Trail records. Archiving may be appropriate at some future date.
Oracle is the enterprise level DB solution preferred by many of the world’s largest corporations due to its flexibility, functionality, powerful capability and robustness.
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Can ProCalV5 be used on an enterprise level as well as by a single user?
- Yes, ProCalV5 Oracle and SQL Server versions are intended to be used at the enterprise level.
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Can ProCalV5 be integrated with other software systems already in place (i.e. CMMS, Document Management, SAP, etc.)?
- Yes, ProCalV5 can be integrated with other software systems. Contact Prime Technologies with your requirements.
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Does Prime Technologies operate under an established and proven Quality System?
- Prime Technologies’ Quality System follows the ISO 9002:1994 format. Although Prime Technologies is not ISO Certified, we have been audited by many FDA Regulated companies, all with favorable outcomes.
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Is Prime Technologies open to being audited?
- Yes, Prime Technologies has been successfully audited many times by some of the largest corporations in the world.
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Is the ProCalV5 Calibration Management Solution 21 CFR - Part 11Compliant?
- Yes, please request a copy of the ProCalV5 21 CFR Part 11 compliance Assessment Questionnaire, which describes how ProCal in conjunction with your firm’s Quality and Good Manufacturing Practices programs combine to provide Part 11 compliance.
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What other companies are using ProCalV5?
- Bayer Corporation, PF Laboratories, Aventis Pasteur, IDEC Pharmaceuticals, Sanofi-Synthelabo, Centocor, Schering-Plough, Baxter Healthcare, 3M, Honeywell
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Is a ProCal V5 Installation Validatable?
- All ProCalV5 products go through extensive Quality Validation Testing as a part of its development life cycle. This Prime Technologies’ assurance to our Customers that the product they receive will work as intended and when combined with a compliant System Validation Process is Validatable.
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How does Prime Technologies help make validation of ProCalV5 easier?
- Prime Technologies provides Validation Test Scripts in a MS Word for you to use directly or reformat, edit and combine with your own testing requirements.
Prime Technologies provides product specific services such as User, Administator and Configuration Training, Data Migration Planning and Execution, Custom Report Development and Process Workflow Consulting.
Prime Technologies also provides complete Validation Project Management and Execution services for any size system.
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What support services does Prime Technologies offer?
- On-site Training and Training Planning and Development for custom implementations,
Configuration and Work Flow Specific Consulting,
Full Project Management,
Installation / On-Site Technical Assistance,
Custom Report Creation,
Mapping and Data Migration Planning,
Validation Services,
Technical Document Development,
Custom Software Development
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Does ProCalV5 provide Access Level Security by User? By Group? Are User Group Access Levels customizable?
- ProCalV5 provides User Access Security on an individual User basis associated with unlimited fully customizable User Groups that can limit access to record types to read only, add/modify, delete and a Technician group that has no access but allows referencing their name to records.
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Does ProCalV5 support hierarchical relationships between equipment, instruments, loops & systems?
- Full function version ProCalV5 applications allow the User to build an unlimited number and variety of hierarchical relationships within the system involving equipment, instruments, loops & systems.
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Can I transfer my existing Calibration Data into ProCalV5?
- ProCalV5 comes with a Data Conversion Utility for migrating existing ProCalV5 databases into ProCalV5. Prime Technologies offers a comprehensive set of Data Migration services that migrate your from most any legacy system(s) into ProCalV5. Service ranges from simple Conversion Program Development to a complete effort including a Data Migration Plan, Requirements Development, Conversion Program Development, Execution and Data Verification for Validation purposes.
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Can I use ProCalV5 to automatically schedule my calibration and PM events?
- Many ProCalV5 Users begin by implementing the Automatic Scheduling capabilities of ProCalV5 and bring in more advanced functionality as they become comfortable with an automated Calibration & PM Management workflow.
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Will ProCalV5 track ‘As-Found’ and ‘As-Left’ data?
- ProCalV5 Calibration Management capabilities begin with tracking basic ‘As-Found’ and ‘As-Left’ data and advance to automatic Out of Tolerance and Control Limit calculations, tracking Vendor, Manufacturer and Installation data for the Instrument, System and Test Instrument, alerts, queries and reports.
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Can I reference my existing and/or new SOP’s to my calibration records in ProCalV5?
- SOP’s and other documents can be tracked, referenced to and accessed from any Item record within ProCalV5.
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Can I get ProCalV5 to provide forms & reports that look like my existing forms & reports?
- ProCalV5 utilizes Seagate Crystal Reports to generate our extensive repertoire of Standard Reports and almost any Custom Report you need. Prime Technologies offers a very reasonable Custom Report Development service or you can utilize your own Seagate resources to implement your own reports.
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Does ProCalV5 have optional modules? What are they?
- PM/Work Order Module – to help manage Work Flow of Equipment and Instrument Calibrations and other Maintenance efforts.
- Training Module – to manage Training Records of Employees that can be utilized to Certify Technicians and others for Metrology task assignment.
- Bar Code Utility – used as a keyboard wedge to scan in specific item information, such as Instrument Item #, Model #, Serial #, Document ID, etc.
- Import/Export Utility & Mobile Workstation – allows the User to work with your ProCal data while disconnected and remote from the Production Database and to upload and integrate the completed work records into the Production Database.
- Field Calibrator Interface – allows the Technician to download Work Assignments to a Self-Documenting Calibrator (see list in next question), perform the Calibration and upload the completed records to ProCalV5 without manually taking data – a truly paperless solution.
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Which documenting calibrators are supported by ProCalV5?
- Currently, ProCalV5 supports:
• Fluke 743B and 744,
• Transmation QuikCal 195,
• Druck MCX-II, TRX-II, DPI605, and DPI 615.
Other calibrator drivers that implement the FCINTF (Field Calibrator Interface) interface are also compatible. Contact us for the most up to date information.
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How can I use ProCalV5 to capture my calibration data real-time, at the various locations where the calibrations are performed and still maintain the integrity and security of a central database?
- ProCalV5 can be provided with an optional Mobile Workstation that allows downloading Work Assignment to a laptop ProCalV5 Access Mobile Workstation Environment. The Mobile Workstation can then be used anywhere to complete the assignment and then the modified data imported to the Production Database with appropriate controls.
ProCalV5 can be provided with an optional Self-Documenting Calibrator Utility for connection to many Smart Calibrator devices for direct capture and upload of Calibration Data.
ProCalV5 can be used via a wireless connection to the Production Database network for direct wireless entry of local fieldwork assignment data into the Production Database.
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How do I get my organization trained to implement and use ProCalV5?
- Prime Technologies provides complete ProCalV5 Training at your facility or ours. Depending on the number of Users involved, we recommend:
- For all systems - Administrator Training session – normally one day very early in the Project,
- For all systems - User Training session– normally one day for every 10 Users, near the go live point of the Project,
- For systems that must integrate into and support a Business / Metrology / Quality infrastructure - One to five days, very early in the Project, of intensive System Configuration Training combined with Work Flow Development for your specific implementation
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How much does ProCalV5 cost?
- A basic single concurrent User Access version is under $1,000. Contact Prime Technologies for other applications and services inquiries.
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If I buy a smaller system, can I upgrade it later to a more robust platform and/or additional user licenses?
- Yes, any ProCalV5 system may be upgraded to a larger or more robust system at any time.
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Does Prime Technologies offer optional software support packages? What do they include / cover?
- Prime Technologies offers three levels of optional Support Agreements for ProCalV5:
Level I, II and III Support includes:
• Start-up Telephone Consultation,
• De-bug / error correction,
• Telephone Operation and Maintenance Support,
Level II and III Support also includes free Upgrades & Enhancements within your version of ProCalV5 and Options,
Level III Support includes free Escrow Service of the source code for your version of ProCalV5 and Options
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Can I upgrade my existing ProCalV5 data to that of a newer ProCalV5release?
- Yes, Prime Technologies includes a Universal Conversion Program with all ProCalV5 upgrades.
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