Compliance Assessment (GxP, Part 11, SOX)

Your business must continually adapt to business issues like new or changing regulations, the development of new activities, or expansion to other markets. Each of those changes can affect your compliance status. Whenever you experience such a change, assessment of current processes and procedures becomes a vital necessity. Backed by years of experience, CTG has the necessary expertise to perform your compliance assessments in the field of GxP, Part 11 and SOX.

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Compliance Remediation

As regulations change and systems are modified, remediation projects must be undertaken. Defining a remediation approach before you start results in faster, more consistent, and more efficient delivery. Since the inception of Part 11, CTG has played a major role in remediation projects for a wide range of clients. Our hands-on 'best practices' approach ensures compliance with all regulatory requirements.

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Methodology Development

A good validation methodology serves as the basis for running smooth and cost-efficient validation projects. Our longstanding practice in methodology development uniquely qualifies CTG to serve as your partner in this field.

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IT Consulting in a Regulated Environment 

In the search for compliant IT solutions, life sciences companies often encounter suppliers with either a good business and regulatory understanding, or a good knowledge of IT. CTG’s unique combination of both makes us your ideal compliance partner. Whether it's technology selection, test automation or ITIL, CTG can make IT work for you!

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Outsourcing

Compliance activities

CTG can staff and organize your regulatory compliance projects with skilled validation professionals specializing in:

• Computer system validation
• Equipment qualification (lab and production)
• Quality coaching (QA review)
• System development in a regulated environment
• Structured testing in a regulated environment 

Resources

CTG’s compliance professionals are renowned for:

• Their ability to integrate easily into your company culture
• Their pragmatic, risk-based approach
• Their willingness to take ‘ownership’ of your issues
• Their ability to add value and insight to your compliance projects
  

Delivery

Depending on the activity and on your preference, compliance activities can be performed:

• Onsite, at your premises
• Offsite, at CTG’s premises (e.g., system development)

Our level of commitment can be:

• Flexible staffing (based on skills)
• Managed staffing (based on function profiles or SLAs)
• Managed service (delivery based or SLA based)

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 Read more about CTG managed staffing services

Training

Developing training in-house is often a time-consuming activity. Keeping your training programs up-to-date in a changing regulatory climate can be an even greater challenge—and one for which few companies have the available resources. In response to customer requests and the growing number of requirements imposed by regulatory agencies worldwide, CTG provides customized training to accommodate your specific needs in the areas of:

• Computer system validation
• IT infrastructure qualification
• ITIL awareness training

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