Online Pharmaceutical Software

QAtor A/S

Headquartered in the sub-urb of Copenhagen, Denmark, one of the world's most famous regions within Life Science, QAtor has within a very short time demonstrated thought leadership and continuous innovation within Risk and Compliance Management applications for the Life Science industry. In co-development with the industry itself QAtor has pioneered and developed Online Software for managing risk, compliance and documentation.more

Online Pharmaceutical Software

QAtor Online Pharmaceutical Software means that re-use of earlier project knowledge for Pharmaceutical companies now for the first time becomes easy and transparent throughout the organisation. The sotware drive down the operational costs of FDA and cGxP compliance, overall reducing the risk of non-compliance. By providing exceptional visibility and control, the WEB-based applications enable the company to more efficiently manage regulated process and product requirements through:

  • Controlled virtual collaboration (workflow management, both globally and locally)
  • Communications by e-mail notification and alerts
  • Electronic signature functionality
  • Electronic archival
  • Secure (SSL Encrypted connection), and
  • Business integration capabilities

in order to reduce the company's Total Cost of Quality. Ultimately, with a ROI within 12 months.

Pharmaceutical Document Management Software: QAbinder™

QAbinder™ is Pharmaceutical Document Management software which stores all types of electronic data in virtual binders, with binder backs, index pages and information. All binders are fully searchable, and it is possible to print physical binders from the virtual ones. Furthermore, the access to information in the binders are subject to a full 21 CFR Part 11 compliant audit trail, so that it can be found WHO and WHEN data was submitted to the system, and data are disabled rather than deleted from the system, so that no information is ever lost.

Application Features:

  • Web-based easy-to-use interface with Explorer Type Navigation and
  • Windows Style Screens
  • Single Database, Multi-site enterprise control
  • Intensive activity logging for security and full audit trail
  • Easy customisation able
  • Search and retrieve functionalities

Pharmaceutical Quality Assurance Software

Using the QAtor Pharmaceutical Quality Assurance Software, the company will enhance Quality Assurance, reduce risk as well as cost reduce significantly thus overall reducing Total Cost of Quality, i.e.:

  • No lost documents or missing signatures
  • Improved regulatory FDA compliance
  • 25-60% less paperwork overall in Quality Assurance
  • 30-50% fewer documents changes, signatures, and initials
  • 20-30% fewer man-hours spent on Quality Assurance documentation
  • 50-60% reduction in time spend on investigations and deviations analysis

All applications are pre-validated according to GxP/FDA. As the applications are WEB-based, the minimum client-software requirements are limited to only Internet Explorer® and Adobe Acrobat Reader®, classified as standard-like software ("used by millions"-approach), overall minimizing post validation resource-need dramatically.

To schedule a ROI visit or if you require more information, please visit our website (the link is in the grey box at the top of the page).QAtor® is an application provider providing Life Sciences with Lean-based compliance software and consultancy to enhance quality and cost reduce significantly.

Configuration Management Software: QAcii™

QAcii™ provides a simple and easy-to-use, cost and time saving tool for Configuration Management, Configuration Item Indexing (CII), and Baseline reports making product annual reviews fast and easy.

Application Features:

  • Electronic Configuration Item Lists (CIL) for hardware, software, documents and networks
  • Automatic version management for Sites, Sections and Systems
  • Search and retrieve functionalities
  • Intensive activity logging for security and full audit trail
  • Configuration management (CII) of all platforms, such as PLC systems, VMS, UNIX, Linux, Windows and network elements etc.
  • Pre-defined reports with portable PDF file export: Baseline, Configuration Item List (CIL) and Audit-trail
  • Various contract type tracking and management

Validation Management Software: QAssure™

Manages the complex regulatory compliance issues in Quality Management, Validation Projects, Collaboration, Documentation and Process Workflows.

QAssure™'s extensive feature set eliminates highly expensive routine work from Quality Assurance compliance & verification process that could be better used elsewhere in the company than at repetitive paper work. Validation features support project transparency and control by using built-in requirement tracking and traceability matrix to ensure that every requirement is specified, designed and tested. QAssure™ enables people to follow only established processes, use structured documents and meet GxP requirements at any time and at all levels

Application Features:

  • Smart structured compliance document and requirements management with built-in Risk Assessments
  • Traceability across documents and automatically generated traceability matrix
  • Enhanced document reviews with controlled online comments for easy processing and statistics
  • Compliance project management with document schedule, standard workflows and task monitoring
  • Implements 21 CFR Part 11 compliant access control, audit rail, electronic signatures, version control and archiving functions
  • Deviations traced automatically if verification steps in validation protocols fail
  • Impact of Change is visible to decide on Change Requests
  • Smart image capturing with integrated and GxP compliant multi-layer image annotation tool

Change Control and Deviation Management: QAchange™

QAchange™ automates the Change Control and deviation process. It supplies fully automated handling of the workflow for any given deviation or Change Control Case and through customisable templates that relates roles and work groups to specific tasks

Application Features:

  • Provides Electronic Change Control, Change Request and deviation handling process
  • Customisable forms with enforcement of required fields
  • Manages electronic reviews and approval process with workflow engine
  • Real time statistical reports for all documents and projects
  • Faster review and approval process
  • Ensures full control and audit trail
  • Improves quality, adds transparency and address regulatory concerns
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QAtor A/S
Laurentsvej 27
2880, Gladsaxe
Denmark

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