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QAvalid QMS™ is a Web based system that manages and controls quality system documentation processes across multiple sites. Conforming to requirements from quality system regulations (21 CFR Part 820) or standards (ISO 9001) is facilitated by replacing paper and manual methods with a fully electronic, automated environment.

Document control, change management, equipment inventory, CAPA, audits and other quality system processes are integrated under a central interface. At the heart of the system, Linksense™ technology allows users to capture essential knowledge, drastically reducing the time to manage documents. Using the web interface and Microsoft® Office, quality professionals can work in a simple manner while the system ensures documents remain consistent and compliant, yet efficient to manage.

QAvalid QMS™ users can focus on the crucial tasks while the system automates recurring compliance and documentation activities. Configurable document review schedules, automated workflows and electronic signatures are supported by automatic audit trail records to eliminate the need to physically transfer documents and sustain compliance. Instead of manually recreating information each time a document is written, QAvalid QMS™ enables advanced reuse through master documents, document and project templates or automatically created and linked documents.

Complete control and real time information about the progress within each document provide managers with the ability to promptly fix problems and reallocate resources to improve efficiency.

The system enables managers to standardize documentation processes, ensuring that all the needed information is captured correctly and in the adequate format. This reduces the risk of errors or non-compliance and makes information easier to manage.

QAvalid QMS ™ is part of the QAvalid™ suite designed to manage and automate quality and compliance processes. QAvalid™ integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

In regulated industries, the QMS solution can be integrated seamlessly with the validation or facility commissioning and qualification modules. It also provides one framework for any company to use QAvalid EMS™ as combined quality and environmental management system.

QAvalid QMS Benefits:

• Ensure all documents follow the desired format and structure
• Connect and integrate QMS processes into an electronic quality management system
• Extensive document and change controls with distribution management and training records
• Utilize compliant electronic workflows and signatures for faster document turn around
• Reduce the time needed to manage documents with Linksense™ traceability technology
• Licensed standards for ISO 9001:2008 or ISO 9001:2001 for direct referencing
• Real-time reporting with built-in reports or custom designed with Crystal Reports
• Use a simple web interface and Microsoft® Office with productivity extensions

An Environmental Management System (EMS) is a consistent set of processes and practices that enable an organization to reduce its environmental impacts and increase its operating efficiency.

Managing the impacts of an organizations activities on the environment is not only about demonstrating a good corporate image, but it can truly assist organizations to maximize the efficient use of resources and reduce waste.

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• QAvalid EMS™

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QAvalid EMS is a Web based system designed to support full traceability and sustain the implementation of an environmental management system (EMS) that meets ISO 14001:2004 requirements.

An alternative to paper and manual methods, the Web based system automates routine tasks, accelerates implementation and reduces the effort and cost of maintaining documents up-to-date.

A set of specially designed ISO 14001 document templates are provided to accelerate the initial phase of the implementation. The standard operating procedures, quality manual and quality policy examples help users interpret the ISO requirements and produce adequate documents.

QAvalid EMS allows full control over EMS information from any location through the Web interface. The system reveals the status of each document and task and sends e-mail notifications whenever documents have to be updated. Integrated corrective and preventive actions (CAPA) and integrated audits ensure a rapid and simple method to meet ISO requirements.

The familiar Microsoft Office user interface can be used to write, review and approve documents allowing users to work in a familiar environment.

A licensed copy of the BS EN ISO 14001:2004 standard can be included within the QAvalid EMS system, allowing users to create electronic references connecting their documents with the EMS requirements.

QAvalid EMS is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

QAvalid EMS Benefits:

• ISO 14001 document templates to accelerate the implementation
• Familiar User Interface – Microsoft Word
• Cost-effective solution
• Complete BS EN ISO 14001:2004 reference standard available

The business environment that calls for companies to constantly improve their performance in order to be successful on the global market is driving the need for real-time visibility and control over business processes.

In order to reduce costs, improve quality, reduce cycle times or boost customer and shareholder confidence, organizations are implementing quality management methodologies such as ISO 9000 or Six Sigma in addition to regulatory requirements like cGMP.

Maintaining a paper based quality management system with disparate systems to control different processes in different parts of the enterprise has proved to be a costly and inefficient practice. As a result, people are looking to deploy enterprise systems that integrate and connect processes and turn traditional document hunting into a well managed and transparent electronic quality management system.

Product Collateral

• QAvalid™ Brochure

View all related literature…

QAvalid QMS™ is a Web based system that manages and controls quality system documentation processes across multiple sites. Conforming to requirements from quality system regulations (21 CFR Part 820) or standards (ISO 9001) is facilitated by replacing paper and manual methods with a fully electronic, automated environment.

Document control, change management, equipment inventory, CAPA, audits and other quality system processes are integrated under a central interface. At the heart of the system, Linksense™ technology allows users to capture essential knowledge, drastically reducing the time to manage documents. Using the web interface and Microsoft® Office, quality professionals can work in a simple manner while the system ensures documents remain consistent and compliant, yet efficient to manage.

QAvalid QMS™ users can focus on the crucial tasks while the system automates recurring compliance and documentation activities. Configurable document review schedules, automated workflows and electronic signatures are supported by automatic audit trail records to eliminate the need to physically transfer documents and sustain compliance. Instead of manually recreating information each time a document is written, QAvalid QMS™ enables advanced reuse through master documents, document and project templates or automatically created and linked documents.

Complete control and real time information about the progress within each document provide managers with the ability to promptly fix problems and reallocate resources to improve efficiency.

The system enables managers to standardize documentation processes, ensuring that all the needed information is captured correctly and in the adequate format. This reduces the risk of errors or non-compliance and makes information easier to manage.

QAvalid QMS ™ is part of the QAvalid™ suite designed to manage and automate quality and compliance processes. QAvalid™ integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

In regulated industries, the QMS solution can be integrated seamlessly with the validation or facility commissioning and qualification modules. It also provides one framework for any company to use QAvalid EMS™ as combined quality and environmental management system.

QAvalid QMS Benefits:

• Ensure all documents follow the desired format and structure
• Connect and integrate QMS processes into an electronic quality management system
• Extensive document and change controls with distribution management and training records
• Utilize compliant electronic workflows and signatures for faster document turn around
• Reduce the time needed to manage documents with Linksense™ traceability technology
• Licensed standards for ISO 9001:2008 or ISO 9001:2001 for direct referencing
• Real-time reporting with built-in reports or custom designed with Crystal Reports
• Use a simple web interface and Microsoft® Office with productivity extensions

Establishing and demonstrating that an adequate CAPA program has been implemented is one of the challenging requirements that companies have to meet.

Inadequate product quality, customer complaints or system’s failure should promptly trigger investigations, solving the problem as fast as possible and preventing it from recurring.

CAPA documentation in most companies is paper based and the CAPA process is poorly integrated with the other quality processes. Additional problems may stem from insufficient internal capabilities and knowledge to sustain the process.

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• QAvalid CAPA™

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QAvalid CAPA™ is a Web based system, designed to efficiently manage corrective and preventive actions processes. QAvalid CAPA™ provides a simple solution with configurable templates to capture incidents, route them through best practice workflows and accelerate collaboration.

Compliance with GxP and ISO requirements is enforced by ensuring that all the necessary information has been captured and that each step of the investigation has been adequately documented. QAvalid users can participate in the CAPA process using electronic forms supported by automatic audit trails and electronic signatures.

Quality managers are able to track the status of each nonconformance, have increased overview into the CAPA system and can rapidly generate data to demonstrate that investigations have been adequately performed and corrective and preventive actions taken.

By connecting CAPA with other quality processes such as change control, audits, SOPs or validation, companies reduce the risk of non-compliance.

QAvalid CAPA™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

In most industries, internal, external audits or supplier audits have to be routinely executed, in order to sustain continuous improvement and meet requirements.

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QAvalid Audit™ is a Web based system designed to efficiently manage quality audits. The configurable solution provides an efficient alternative to paper or manual forms. Geographically dispersed companies can save time by initiating and controlling remote audits from any location through a simple Web interface. Users can perform controlled editing, review and approval of audit records while working offline within the familiar Microsoft® Word interface.

Collaboration and compliance are sustained through electronic workflows supported by automatic audit trails and electronic signatures. The system allows reuse of information and can manage audit and document review schedules, enforcing compliance.

The QAvalid Add-In for Microsoft Office can be used off-line as a laptop application that supports and enhances the entire field audit process. Its features include: data gathering, detailed review of the quality system, recording audit decisions and reports.

QAvalid stores information from relevant reference standards or regulations making them available to the auditor while in the field, eliminating the need to search for referenced requirements and other data that is commonly needed during the audit.

QAvalid Audit™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

Change Control and Configuration Management (Change Management) are closely related systems, responsible for identifying and tracing changes to documents and equipments. Within regulated environments, changes to the quality system have to be reflected in the documentation and must pass through a formal approval process.

In order to ensure that quality systems continue to produce consistent and compliant results, changes must be carefully analyzed, by understanding their impact and taking all the necessary measures to mitigate risks.

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QAvalid Change™ is an electronic system designed to support a formal, GxP compliant method of implementing changes. All modifications are implemented through a specially designed workflow that is supported by automatic audit trails.

By storing all document baselines and linking them to the change requests QAvalid Change™ allows users to accurately see what was modified, when, why and who approved it.

The Web based system allows users to collaborate in the change process in a simple manner from any location. Special reports provide users with an overview of all changes within a particular part of the system or within a specific time interval.

QAvalid Change™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

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• QAvalid EMS™

View all related literature…

QAvalid EMS is a Web based system designed to support full traceability and sustain the implementation of an environmental management system (EMS) that meets ISO 14001:2004 requirements.

An alternative to paper and manual methods, the Web based system automates routine tasks, accelerates implementation and reduces the effort and cost of maintaining documents up-to-date.

A set of specially designed ISO 14001 document templates are provided to accelerate the initial phase of the implementation. The standard operating procedures, quality manual and quality policy examples help users interpret the ISO requirements and produce adequate documents.

QAvalid EMS allows full control over EMS information from any location through the Web interface. The system reveals the status of each document and task and sends e-mail notifications whenever documents have to be updated. Integrated corrective and preventive actions (CAPA) and integrated audits ensure a rapid and simple method to meet ISO requirements.

The familiar Microsoft Office user interface can be used to write, review and approve documents allowing users to work in a familiar environment.

A licensed copy of the BS EN ISO 14001:2004 standard can be included within the QAvalid EMS system, allowing users to create electronic references connecting their documents with the EMS requirements.

QAvalid EMS is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

QAvalid EMS Benefits:

• ISO 14001 document templates to accelerate the implementation
• Familiar User Interface – Microsoft Word
• Cost-effective solution
• Complete BS EN ISO 14001:2004 reference standard available

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• QAvalid Brochure

View all related literature…

QAvalid Audit™ is a Web based system designed to efficiently manage quality audits. The configurable solution provides an efficient alternative to paper or manual forms. Geographically dispersed companies can save time by initiating and controlling remote audits from any location through a simple Web interface. Users can perform controlled editing, review and approval of audit records while working offline within the familiar Microsoft® Word interface.

Collaboration and compliance are sustained through electronic workflows supported by automatic audit trails and electronic signatures. The system allows reuse of information and can manage audit and document review schedules, enforcing compliance.

The QAvalid Add-In for Microsoft Office can be used off-line as a laptop application that supports and enhances the entire field audit process. Its features include: data gathering, detailed review of the quality system, recording audit decisions and reports.

QAvalid stores information from relevant reference standards or regulations making them available to the auditor while in the field, eliminating the need to search for referenced requirements and other data that is commonly needed during the audit.

QAvalid Audit™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

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• QAvalid Facility™

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QAvalid Facility™ is a Web based system designed to manage facility commissioning and qualification projects. Unlike paper or spreadsheet systems, QAvalid Facility™ allows engineering and commissioning professionals to control and track the status of each equipment or system from the initial requirements through vendor selection, risk assessment and qualification.

Users are able to connect and synchronize the equipment inventory with requirements, risk assessments or qualification documents. This ensures that the inventory is kept up-to-date and that the status of each equipment can be promptly justified by retrieving the attached documents.

Configurable electronic workflows supported by automatic audit trails and electronic signatures reduce the time needed to complete the project and ensure that FDA requirements are met. Integrated change control and configuration management also ensure that documents are kept compliant.

The QAvalid Add-In for Microsoft Office allows users to perform controlled document writing, reviewing, approving and testing within Microsoft Word. QAvalid Facility™ is efficient and simple to use because it captures all the necessary information within the actual documents and users are not required to reenter information.

QAvalid Facility™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

QAvalid Facility™ Benefits:

• Ensures that regulatory requirements are met substantially faster than with current systems
• Provides unique content level linking between documents to reveal change impact
• Monitors compliance throughout the project (including project specific procedures)
• Ensures that regulatory requirements are met substantially faster than with current systems
• Documentation and change control activities easily managed with engineers and contractors
• Provides unique content level linking between documents to reveal change impact
• Integrated support for HAZOP Risk Assessment methodology
• System GxP impact assessment and qualification status included into Validation Master Plan (VMP)
• Integration is available for mainstream systems such as Microsoft Office, Microsoft Project and Primavera

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• QAvalid Brochure

View all related literature…

QAvalid Change™ is an electronic system designed to support a formal, GxP compliant method of implementing changes. All modifications are implemented through a specially designed workflow that is supported by automatic audit trails.

By storing all document baselines and linking them to the change requests QAvalid Change™ allows users to accurately see what was modified, when, why and who approved it.

The Web based system allows users to collaborate in the change process in a simple manner from any location. Special reports provide users with an overview of all changes within a particular part of the system or within a specific time interval.

QAvalid Change™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.