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 In this competitive world “Quality” plays
an extremely important role in moulding
process of Material to Money. Everybody
believes that where there is proven
Quality there is demand products and
services. It is no gainsaying the fact that,
‘higher the quality’ then ‘higher the
demand’. |
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In the world of Pharmaceutical business, Quality is
defined in terms of GxP (GMP, GLP, GDP, GCP, GEP
etc.). There are several regulations like WHO GMP,
USFDA, MHRA, TGA and Code for Federal Regulations
(21CFR).
ICH guidelines are also available word wide to
harmonize the process of compliance and
registration of products.
The manufacturer, customer and the regulatory
authorities will have to depend on Proper
documentary evidence which will determine the
quality of drug manufactured and delivered. It is to
be understood that the product’s evidence is the
documents.
Quality drug always remains on top priority for all
drug manufacturers world wide. GMPPro – Quality
Document Management System empowers drug
manufacturers to manage all necessary documents
with proper GMP and quality guidelines easily. (ISO,
WHO, ICH, FDA, TGA, MHRA and other standards).
GMPPro is the 1st pharmaceutical GMP compliance management system which is intently
designed and developed for bulk drug manufacturers. It is a cGMP driven application developed and
designed by using latest software technologies and safest database backgrounds. It is designed and
developed by vastly experienced and high skilled professional GMP experts who have hands on experience in
the industry. As a result, pharmaceutical companies no longer need to spend a few lakhs if not crores of
Rupees on conventional methods for document management (Hard copy management) to manage
GMP-related information.
GMPPro is an approach to achieve 100% cGMP compliance and effective document management that
assures to deliver quality outcomes. All the activities are governed by an extensive set of controls and actions
which leads by system driven quality guidelines.
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| Key Features |
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- 100% Quality compliant system.(21 CFR Part 11 & ICH Q7)
- Paperless Quality Documentation Management System
- Exclusive solutions for Pharma manufacturers.
- Auto generated customised reports.
- Mobile & e-mail alerts on major issues.
- Organised approach in data association from one department to another.
- It guides users towards compliance.
- Auto up gradation of tasks, reports, complaints etc. till they get closed.
- It helps to build an enhanced quality system in the organisation.
- It helps to manage the activities during Authority / Customer audits.
- It provides reference guidelines to get high quality results.
- It generates multiple data reports for several Regulatory needs.
- It provides online document management on day to day operations.
- It reduces the burden in hard copy management and provides the required reports on single click.
- High degree of quality through out entire document management system.
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| Benefits |
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- Unique repository for all quality management system documents.
- It saves lot of time for employees during document handling, achieving & retrieving.
- One central point administration and can handle multiple locations / units / sites.
- User defined dashboard contents for important tasks and follow-up activities.
- Regulatory compliant template forms & reports, helps to users during document preparation.
- Easy to retrieve the historical data during review and investigation of deviations/changes/incidents etc.
- Automatic gathering of data, itself by system driven functions for making of annual product reviews.
- It reminds users for pending tasks and activities by auto generated alerts. (eMails & SMS).
- Ensure the correct documents are used across all departments by automatically presenting the correct &
live documents to employees for error free documentation.
- All working hours become more accountable by providing instant summary on reports/tasks etc.
- Save Money and man hours by configuring Quality Document Management System (QDMS).
- Enforced quality compliant system by using pre defined guidelines (ICHQ7A) & GMP driven database.
- QDMS dashboard and alerts helps users to manage important audits, incidents, changes etc.
- Backups for historical data into CDs/DVDs.
- It reminds to employees on pending tasks automatically for complete follow-up.
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