IT Quality & Regulatory Compliance
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.
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.
Solutions
Our experts help you achieve your compliance objectives efficiently and effectively:
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.
“As CEO, I have appreciated CREO’s network of subject matter experts, ability to accurately assess problems and offer rapid solutions, and facilitation of discussions that enabled our team to become the leaders our organization needed to drive our vital vision and mission.”
— Stacie M., Veritas Collaborative
IT Quality Assurance & Oversight
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.
Solutions
We help you achieve your quality assurance and oversight objectives through:
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.
Solutions
We help you achieve your specific CSV objectives by leveraging our deep industry knowledge and compliance experience:
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.
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