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Life Sciences and Regulatory ComplianceQuality 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.
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Medical Devices
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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.
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Pharmaceutical and Biotechnology
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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
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Life Sciences Services & Supporting Documentation
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Professional Services include:
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Supporting documentation to aid in your validation of Q-Pulse includes:
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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.
- 30-day satisfaction guarantee
- Quality America Partnership with Gael Quality
- System Requirements, Online Customer Zone and FAQ
- Low-cost telephone or email support with valid Annual Support Agreement
- Training is available (on-site or online) to help you put your Quality Management system to effective, efficient use
- Implementation Services
- Data Migration Services
- Help System and Step-By-Step User Manual
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