IT Quality & Regulatory Compliance Services

Comply with regulatory requirements and ensure your IT systems and infrastructure meet the quality assurance expectations applicable to your business needs.

CREO takes a practical approach to regulatory compliance and IT quality, and our solutions are designed to help our clients remain compliant without  impacting business growth and efficiency.

How We Help Clients

  • Regulatory Compliance
  • IT Quality Assurance & Oversight
  • Computerized System Validation

Regulatory Compliance

Our compliance experts can help you efficiently comply with regulatory requirements applicable to your business needs. 

CHALLENGES

Regulatory compliance expectations are only increasing as governing bodies aim to increase security, privacy and quality protections surrounding sensitive information and processes.  Your customers also have their own compliance requirements and expect you to demonstrate your alignment with these regulations. Many regulations have complex and overlapping requirements that can be difficult to reconcile, and penalties for non-compliance range from financial fines to disrupting clinical trials. ​

Our Solutions

Compliance Strategy & Solutions

We first aim to understand your holistic compliance needs. Then we design compliance approaches that can be applied across multiple regulations, saving you time and money.

Compliance Support

We provide expert compliance solutioning related to 21 CFR Part 11, Annex 11, Predicate Rules, CSV, Data Integrity, GxP and GAMP 5.

Data Integrity

We will review and assess the completeness, consistency and accuracy of regulated data aligned with ALCOA standards.​

IT Quality Assurance & Oversigh

Our seasoned experts will help ensure your IT systems and infrastructure meet the quality assurance expectations applicable to your industry. ​

CHALLENGES

Quality ensures that products and services align to expectations of the industry while complying with applicable regulatory requirements. In addition to keeping processes efficient, quality can also keep people safe. The goal and role of IT quality in an organization is no different. Organizations that must comply with strict quality expectations must maintain documented policies and procedures and demonstrate adherence to defined processes. As complexity can be high, it’s important that IT quality operations are efficient and effective. ​

Our Solutions

QMS and Supporting SOPs

We oversee QMS implementation projects and ensure compliance with existing SOPs.

COTS & Bespoke Systems

We can provide QA services for 3rd party products and custom developed solutions.

Audit Support (Supplier, Internal, Responses)

We’ll help with audit preparation, execution, responses and follow-up.

SOP Alignment

Our services include authoring, refinement, standardization and consolidation of policies and procedures documentation.

Computerized System Validation

We offer a wide range of computerized system validation services to meet your organization’s industry expectations and compliance needs.​

CHALLENGES

Computerized System Validation (CSV) is the confirmation, by examining objective evidence, that system specifications consistently and reliably conform to user needs and intended uses and ensures compliance with applicable regulatory requirements.  Regulatory and industry CSV expectations have increased in complexity with evolving guidance and new regulations for electronic records, electronic signatures, and data integrity.  As a result, absent, inadequate, or poorly managed CSV programs will likely be cited by regulatory agencies and client auditors, resulting in significant consequences for organizations, including product recalls, loss of sales, and reputational damage.

Our Solutions

Program Development

Establishing a fully compliant GAMP 5 based CSV program including developing policy, procedures, work-instructions, templates.

CSV Planning & Execution

Providing guidance, oversight and/or project management of system validation projects.

CSV Advisory and Training

Supporting your CSV team with our seasoned CSV experts who offer both informal advisory and classroom style training.

Smarter Medicine with Data-Driven Healthcare

Our People

Connie Pearcy

Senior Managing Director

To each new engagement, Connie brings her leadership experiences working in nonprofit, private, and public companies across…

Kevin DeLeon

Principal Consultant

Kevin has worked for nearly 30 years at the juncture of information technology and regulatory compliance to develop…

Dennis DeWolf

Senior Manager

Dennis’ proficiency extends across various domains, encompassing defensive cybersecurity, quality assurance, compliance, risk management…

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