Quality software

IT EXPERTS ON QUALITY MANAGEMENT

Implementing document management systems

  • Quality Project Management
  • Audits: Pole
  • DMS:
  • Javalin.
  • CITSeGuide.
  • Incedence/CAPA: CITSSupport
  • Acc21CFR
  • Training.
  • Pharma Stock.
  • Calibrations.
  • Audit.

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.
All throughout its history, Labware has closely collaborated with its customers to comply with all the responsibilities in an adequate an innovative manner. Thus helping its customers to guarantee and increase both processes and products’ quality.
As a results of this synergy and experience, many computing systems have been consolidated into the bases on which integral quality systems can be integrated.

Quality Project Management

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 management

Our 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.

DMS:

  • Javalin.
  • CITSeGuide.

Incedence/CAPA: CITSSupport

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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Labware Barcelona · J.Sebastian Bach, 24 08021 Barcelona · Tel. +34 932 405 330 · Fax +34 934 144 109
Labware Madrid · Urbanización Maracaibo · c/Vizcaya 11 · 28231 Las Rozas, Madrid · Tel. +34 915 516 853 · Fax. +34 915 526 799
Labware Argentina · Av. Del Libertador 6550 2ºB · C1428ARV C. A. de Buenos Aires, Buenos Aires · Tel. +54 11 4785 4234 · Fax. +54 11 4785 7617

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