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
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 & 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.
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.
Featured Whitepaper
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…
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
Independent Pharmacy Business Strategies
In today’s fast-paced healthcare landscape, independent pharmacies play a vital role in delivering personalized care and fostering strong community connections. However,…
Data Integrity Requirements for Paper Based Records in a GxP Environment
As I noted in a prior article, GxP Data Integrity can be defined as the extent to which data are complete,…
Inflection Points — Opportunities and Challenges
“Just as a teenager can no longer wear the shoes or abide by the restrictions set out for a younger child,…
Eight Ways Life Sciences Leaders Can Kickstart Artificial Intelligence
Discover 8 key ways that life sciences industry leaders can start making progress in the application of AI across their organizations.
Power Up Your Organization: A Comprehensive Comparison of Teams Premium and Copilot
Learn about the AI capabilities and features of Microsoft’s Copilot and Teams Premium to optimize team performance and secure collaboration.
Finding the Right Key: Transforming CRO Operations with Integrated ERP Systems
In an increasingly complex clinical trials landscape, optimizing and integrating ERP systems is the key to unlocking enhanced CRO operations.
We’re ready to help.
Ready to transform your data into a valuable and usable asset?
Don’t wait to connect with CREO.