Quality software
IT EXPERTS ON QUALITY MANAGEMENT
Implementing document management systems
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One of this industry’s crucial pillars is without any doubt, quality management. The following are some of the responsibilities of quality management. It ensures that the personnel is properly qualified and guarantees that the service and raw material providers comply with the existing regulations’ requirements. It also proves that all documents are filed in the correct manner and that all changes and mistakes are managed with efficiency and not left to everyday routine. |
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Quality Project Management
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Each customers is special to us, therefore, we provide different solutions for document management in order to meet all the needs that each of our customers may have. For example: Documents’ life cycle management (Development, review, approval, and coming into effect), Administration of different access levels and the rights over them (Reader, editor, collaborator, etc), Different document versions, Workflows, Automatic format conversion, handling the most diverse type of documents, the same document in different languages and many others. |
Audit managementOur solutions for audit management allow registering sample questionnaires for both internal and external audits, it also registers those audits’ results (assigning punctuations and calculating percentage). Moreover, it enables the automatic report generation in the most diverse formats which reduces significantly the workload associated with the audit process and making easy the evaluation and interpretation of the results. |
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DMS:
- Javalin.
- CITSeGuide.
Incedence/CAPA: CITSSupport
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Acc21CFR
- Training.
- Pharma Stock.
- Calibrations.
- Audit.
Quality guarantee system based on the GAMP5 that ensures the correct practices in the development and maintenance.
Our quality system has been audit by GSK and Boheringher.
Application required in order to comply with the CFR 21 –part 11 regulation without removing the existing Microsoft Access applications.
Customize settings:
- Access control.
- User management.
- Electronic signature.
- Audit Trail.
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