More than a software development company, Prime Technologies can offer you assistance to implement your new FDA/ISO compliant calibration management solution. Our professional team is ProCalV5 trained and has the experience and training needed to guide your project in accordance with FDA and ISO guidelines.
Full-time/ Part-Time, Short or Long-term, we offer a wide range of
services to include:
- Project Management
- CMS Training
- Document Preparation
- Project Planning
- Software Validation
- System configuration
- SOP Development
- Regulatory Compliance Consultation
- Gap Analysis
- Data mapping
- Record building
- Calibration consultation
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Documentation Expertise
Let our Professional Staff save you time and effort when preparing critical project documents. We offer expertise and templates for the development of:
Functional Specification Requirements
- User Requirements Specifications
- Functional specifications
- Data Migration Plan
- Master validation Plan
- URS/FRS Gap Analysis
- IQ/OQ/PQ
- System Design Specifications
- Risk Assessment
- Work Flow development
- System Usage SOPs
- Requirements Traceability Matrix
- Testing & Validation Strategy
- Training certification
- Final Reports
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Project Planning & Management
A successful project has clearly defined objectives, assigned tasks, a realistic achievable plan and effective management. The Prime Technologies Team will deliver;
- Definition of required Tasks
- Project Plan
- Resource allocation
- Project Management
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Integration to other systems
Make maximum use of the best of breed solutions. Our Data Exchange Utility offers a convenient interface allowing calibration data and records to be shared with other applications. Integration to SAP, CCMS and other platforms is now possible. We have the IT professionals who can help.
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Data Migration
Data mapping is a customary service that we provide to our clients when they change from older software applications. Older systems typically have a less concise data structure. Moving to ProCalV5 gives you tighter control of your information and upward compatibility to future releases. Verification tools and testing is a normal practice with this service.
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Custom Report Development
Each version of ProCalV5 includes over seventy reports ranging from customary scheduling and calibration certificates to statistical management reviews. New reports can be added and existing ones modified Using Seagate’s Crystal Reports. Reports can be made specific to user accounts and individual access rights.
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Test Type Packages
ProCalV5 offers a powerful and flexible user interface that is configurable to a wide range of instruments, systems and devices. In many cases, specific equipment requires specific tests outside the common format. Some examples are analytical lab equipment, HEPA filter certification, quad testing of scales & balances, pipette certification, etc. In such cases, specific fields, routines and algorithms may be needed.
Many “Test Type Packages” (TTP) with accompanying reports have been developed for ProCalV5 and the library of those available keeps growing. These unique modules are individually developed and validated. They snap into the main application. Please call If you have needs for specific test packages.
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ProCalV5 Training
Significant improvements in efficiency and quality management can be achieved with ProCalV5. In many cases, return on investment is almost immediate. Systems experts are available to help your administrator with the development of effective configuration and work flow practices followed by professional end user training. Training can be customized to your needs and classes can be scheduled at your facility or at our training center in West Chester, PA.
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Validation & Testing
As defined in our quality system, each version of ProCalV5 is validated before release following current GAMP guidelines. Prime Technologies development and testing policies have been audited and approved by most of the largest Life Sciences companies. Detailed validation scripts are available in both non-executed (MS Word) and executed (.pdf) packages. Experienced software validation and technical writers are available to support your project.
- Validation Strategy Document
- Risk Assessment
- Test Plan
- Installation Validation protocol development, IQ
- Operation & Performance Qualification Protocol, OQ, PQ
- Supervision and execution of Validation and UAT
- Validation summery documents
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