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Complaint Handling Software – PQ
REMETREX® PQ is a web-based,
enterprise level complaint handling system designed to increase your
productivity while enabling you to achieve continuous improvement, enhance
quality and meet regulatory compliance.
PQ Features
- Design consists of multiple layers of access
control and multi-location complaint numbering schemes
- 21 CFR Part 11 and 21 CFR Part 820.100 compliant
- Designed to process complaints from open to
close and provide complete documentation for medical device and pharmaceutical
reporting
- Complaints are tracked from general to detailed
descriptions, utilizing a three-level category scheme
- Provides multiple methods of communication,
including assigning file responsibilities and progress monitoring
- Email notifications can be generated by complaint
requirements, workflow assignments or custom data driven events
- Designed for customization to an individual
company's requirements, such as contact demographic information, product
specific information, reports and additional options required by each
company
- Provides ability for managing corrective actions,
batch record reviews and product analysis
- Provides ability for attaching and modifying
photos, documents, Emails, PDFs etc. to complaints. These files are
securely stored in the system database and may be downloaded by system
users. Attachments are complete with audit trail
PQ Reporting Module
- Generate reports based on a variety of complaint
file information
- User defined report parameters can be saved
and reused, saving time and providing reporting consistency
- Reports can be generated in PDF, Excel and
other popular formats
- Reports can be run in real time, or submitted
to batch and Emailed back to you upon completion
- You can also schedule your reports once and
have them run daily, weekly, monthly etc. and receive them via Email
- Report titles are customizable and can be
saved with report parameters
- Selection criteria chosen can be appended
to the report, to provide furtherparameter clarification
- Adhoc reporting component allows you to select
the data you want, in the sequence you want with the criteria you want,
all within an
easy and intuitive interface
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