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Document Control Software: Q-Pulse for Life Sciences


Life Sciences and Regulatory Compliance

Quality Management and Regulatory Compliance are core business processes within the Life Sciences environment, with the FDA, the MHRA and the EMEA requiring that products, services and processes are provided and performed in a robust Quality-Assured environment that meets standards such as 21 CFR 820 and GxP.

Many organizations approach Quality Management and Regulatory Compliance in a disjointed manner resulting in a duplication of effort, an increase in unnecessary overheads and ultimately a missed opportunity to gain valuable business advantage from such actions.

    Medical Devices

Medical Devices

Life Sciences organizations across the globe are turning to software systems and support that rid them of the bureaucratic burden of compliance, enabling them to meet their regulatory commitments in a streamlined manner, whilst unlocking the latent business improvement opportunities within their management system data.

Q-Pulse is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments including ISO 9001, GxP and ISO 13485.

    Pharmaceutical and Biotechnology

Pharmaceutical and Biotechnology

The Q-Pulse Advancement Framework provides a seven-step solution with which you can advance your organization through regulatory compliance. These seven simple steps can make a lasting difference to your organization by transforming necessary compliance activities from a costly overhead into a business benefit with proven competitive and commercial advantage.

Software services and support form a fundamental component of your Q-Pulse implementation. We offer a complete range of professional services for the Life Sciences sector to ensure that your Q-Pulse implementation progresses as smoothly as possible, with minimum impact to your valuable resource and maximum return from your software investment.

See Life Sciences Brochure    Blood Bank Case Study    Organ Bank Case Study     Medical Device Case Study


    Blood Services

Blood Services

Life Sciences Services & Supporting Documentation

Professional Services include:
  • Software installation and deployment.
  • System consultancy and configuration.
  • Advice and assistance on your IQ / OQ activities.
  • Configuration and activation of Q-Pulse's 21 CFR Part 11 controls.
  • Super-user training for the key implementation team.
 
Supporting documentation to aid in your validation of Q-Pulse includes:
  • Sample procedural documentation from the software development lifecycle.
  • Sample user requirement specifications.
  • Detailed information on the numerous test methodologies applied when developing Q-Pulse.
  • Real-time access to Gael’s management system documentation to allow you to remotely assess the validity of our design, development and verification processes.
General Information

Our value-pricing provides THE cost-effective solution for Document Control, Corrective Action, and Quality Management software.

See our Q-Pulse Overview for more complete details or to contact us to schedule a webex presentation.
Our support has been unequaled by the competition since 1983, and is now even better with real-time Web-based support and training.

 

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