What is the ECL2 QSP (Quality Support Program)?

• We designed the Quality Support Program (QSP) to provide you with additional on-site support. Sometimes you need a little extra help getting things rolling and knowing we will be onsite creates the momentum and focus you need.

Additional Quality staff you never knew you had

Proven Quality Management experience combined with exceptional Q-Pulse wisdom, the best Q-Pulse support on the planet.

Ways to use the QSP

• Custom Report Development
• Custom Monthly, Quarterly or Annual Reporting
• Custom Form Development
• Strategic Planning Facilitation
• Auditing Services
  • Corporate Compliance Audits
  • External or Internal Audits
  • Audit Facilitation
• Enterprise Risk Identification & Mitigation Facilitated Session

Support

What you should know

• Stay away from vendors that try to sell you a “validated” system.  Your organization must validate the system for its own use.
•  The choice between Verification and Validation depends upon how the software is categorized according to GAMP (Good Automated Manufacturing Practices).
• Validation isn’t a one-time discrete event.  You need to maintain your validation status against any future system changes.

How much validation is enough?

• Validation activities can take up significant staff hours.  We can help you reduce the time and effort required by focusing on the significant areas for your company.
• ECL2 utilizes a risk-based approach based upon GAMP 5
• We work closely with our clients to capture your requirements; and in developing the appropriate level of validation based upon what you deem as areas of potential risk.
• We will develop all of the documents for you based upon a continuous dialogue and give you the option to execute all of the testing.   This gives you greater confidence in the system that it truly has met all of your specific requirements.
• We ensure that you know how to navigate all of your documentation and that you have an ongoing strategy for when changes occur.
• Our validation work has been carefully scrutinized and proven time and time again to satisfy the regulation during  inspections resulting in zero findings.
• If your preference is to work from a package of guidance documents, examples and templates, we can provide you with our ECL2 Q-Pulse Validation Pack.
• Please contact us for more information.

• We configure with our clients, providing an important opportunity for you to learn the system
• Every decision is mapped along the way, so that we can provide the most educated support for your organization for years to come
• We incorporate industry best practices, so you don’t have to reinvent the wheel, we perfect it to each client’s unique circumstances
• Our Consultants have all been quality professionals themselves.  We can quickly help you make the best decisions throughout the process and we continue to support you post-implementation.

• Uncompromising, structured, hands-on  training methodology
• Training catered to all levels of your organization, from front line occasional users to the most advanced “super” users and administrators
• Providing customized “cheatsheets”, training references and additional resources to ensure your understanding and continued success

On your server or ours!

On your Server – Local installation managed by your own IT staff. Simple, economical, no need for additional resource costs to manage your QMS solution.

Hosted

Limited IT infrastructure? Let us host your Q-Pulse server.  24/7 server support, no hassle.

• ECL2 provides hosting services through Amazon.
• Data is maintained and stored securely in accordance with ISO 27001 information standards.
• Comprehensive backup of critical data and disaster recovery