Software Supplier Auditing

CQV’s QA organization also provides compliance auditing services to clients who are seeking an assessment of internal and vendor regulatory compliance integrity. CQV certified audit personnel review SOP’s, software development procedures and the documented evidence of utilization to assess the level of compliance. Although audits normally focus on systems validation, documentation practices in general are evaluated relevant to the particular governing regulations. The audit process is consistent with the recent PDA Software Supplier Auditing and Qualification Committee recommendations (reference PDA Technical Report 32). The audits review documentation and focus on:

• Accuracy/Reliability
• State of Control
• Clarity/Comprehensiveness
• Completeness/Appropriateness

An audit team will be established with representatives from both the client and CQV. The following tasks are typically accomplished during an initial overview:

• Review corporate guidelines and policies
• Review validation plans
• Interview individuals responsible for systems operation
• Define the system capabilities
• Identify any related operations
• Define interfaces with networks or other systems

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21 CFR Part 11 Compliance

CQV has active Part 11 participation with PDA, ISPE, GAMP, IVT and ASQ. CQV has completed over 350 Part 11 projects and, as the guidelines continue to develop, advise and contribute regulatory on Part 11, CAPA, and Risk Based Approaches to compliance through participation in committees, tasks groups, conferences, and published papers…

• e-Records
• e-Signatures
• Risk Based Approach
• Audit Trails
• Impact Analysis
• Risk Assessments
• Key-Note Speakers
• Quality Reviews
• Efficient SOP development

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PDMA

CQV provides auditing services that are truly independent. We don’t provide reconciliation services and we don’t have a sample fulfillment warehouse, thus allowing us to be free from conflict of interest questions.

We can provide you with vendor audits of your sampling program service providers We are able to provide an in-depth review of your vendor’s process as well as compliance with applicable regulations such as 21 CFR Part 11.

We can provide you with field operations audits to verify that your sales reps are maintaining appropriate documentation and storage of product samples.

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GxP Training and Quality Improvement

Instructor-Led 1/2 Day, 1 Day, or 3 Day Compliance Training

CQV keeps pulse of the changing FDA guidelines & are experts in worldwide training of regulatory issues and trends. Utilizing a Best-Practice Approach, CQV has created a suite of programs that assure Quality Improvement & ROI.

• Tailored /Company Specific Training
• Executive Awareness Courses
• Internal Process / SOP’s
• Introductory to Advanced
• ‘How-to’ Courses
• BPI/ Six Sigma
• Train the Trainer
• Quality Coaches
• Knowledge Transfer/Retention

Reach Large Geographies with our Web-based or CD-ROM Technology

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Sarbanes-Oxley Services

The Sarbanes-Oxley Act (SOX) is intended to prevent corporate financial abuse by insuring the integrity of gathered and reported data. It requires a company’s annual financial report to contain an internal control report that states that it is the responsibility of management to establish and maintain an adequate internal control system, and to contain an assessment of the effectiveness of the internal control structure and procedures that insure the integrity.

SOX has many elements in common with computer systems validation. Section 404 requires a demonstrated state of control over financial systems. Computer systems are a large part of this control mechanism. Computer validation requires a well documented state of control over GxP systems. Computers are a large part of this control mechanism as well.

CQV is able to provide SOX related services regarding necessary controls for IT systems. These systems are a significant part of the overall corporate controls. Typically the following areas are impacted by SOX:

• Standards & Compliance
• Project Management
• Disaster Recovery
• Problem Management
• Change Management
• Security Management
• Service Level Management

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Global Business/Supply Chain Management Systems Compliance

Today’s global market demands that companies operate more efficiently than ever. Instead of discrete applications that do not communicate outside their own environment, companies are implementing global business solutions that address the needs of the enterprise. CQV understands the business needs of the corporate environment, and merges their business systems savvy with their regulatory compliance experience to provide solutions to the FDA regulated industry. Our experience includes the leading ERP/MRP, Content Management and Supply Chain applications, as well as Document Management (EDMS), Corporate Quality, and CAPA Systems. Whether you need proven Project Managers to affect a compliant business solution, or need a Validation Master Plan for all of the shared applications, CQV can address your compliance concerns.

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Training

A recent survey found that the average company provides some formal training for over 78 percent of its employees, and that the top ten percent of the companies surveyed train 98.4 percent of employees in their organizations.

CQV follows a training analysis and development methodology that ensures high quality and repeatable results. We work closely with our clients, analyzing their unique needs to deliver cost effective solutions that maximize the return on training investment. Delivery strategies are tailored to the needs and budget of the organization. We enable our clients to efficiently reach large or geographically diverse audiences while improving knowledge transfer and retention.

CQV offers a variety of training courses to address current regulatory, technical, and quality assurance issues. We also develop custom training solutions o address customer-specific needs. Our scope of training support services includes:

• Training Systems Development
• Training Procedures
• Instructor-led Training Programs
• Train the Trainer Programs
• Technology Delivered Training Programs and Systems (e-Learning)
• Support for Learning Management Systems (LMS) lmplementation
• Enhanced Performance Support Systems (EPSS)
• Training Return on lnvestment (ROI) Studies

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