Regulatory Compliance Solutions Blog

What is Computer System Validation?

Thursday September 21, 2023

Explore the intricacies of Computer System Validation. Dive deep into its significance, processes, and best practices to ensure reliable and compliant IT systems in today's digital age.

The Importance of IQ, OQ, and PQ in 21 CFR Part 11 Compliance

Thursday August 24, 2023

Dive into the pivotal role of IQ, OQ, and PQ in 21 CFR Part 11 compliance. Understand their significance, challenges in implementation, and Arbour Group's expertise.

The Role of Audit Trails in 21 CFR Part 11 Compliance

Tuesday August 15, 2023

Explore the significance of audit trails in 21 CFR Part 11 compliance. Dive into the essentials, challenges, and Arbour Group's expert solutions for seamless adherence.

The Different Classes of Medical Devices

Thursday March 30, 2023

Learn how the FDA regulates medical devices, the difference between medical device classes, and the importance of regulations for medical devices.

Regulatory Compliance Guide for Biotech Companies

Tuesday February 28, 2023

How can biotech companies ensure compliance? How is the biotech industry regulated? Why is Compliance Important in The Biotech Industry? Discover what Biotech companies need to stay compliant with governing agencies.

Why FDA Regulations Are Important for The Pharmaceutical Industry

Tuesday January 31, 2023

Arbour Group breaks down compliance guidelines for the pharmaceutical industry, how the FDA regulates pharmaceutical companies, and how the pharmaceutical industry should address FDA regulations.

CSA & CSV: What the Experts Know

Monday November 14, 2022

Brian Slocum is a Senior Consultant and Project Manager for Arbour Group, a global provider of regulatory products and services for the Life Sciences for over 25 years. He has broad experience with software applications enabling manufacturing, distribution, engineering, quality management, marketing, clinical affairs, and related business functions. Brian also has extensive experience in various software development (SDLC) methodologies and their effective use within a regulated environment. On September 13, 2022, the FDA released draft guidance, for comment purposes only, on Computer Software Assurance (CSA) for Production and Quality System Software. With the draft guidance, Arbour Group presents its subjective opinion.

Change Control: Fundamentals for the Life Sciences

Friday October 21, 2022

Why is managing change controls essential to the life sciences? What do pharmaceutical, medical device, and biotechnology companies need to know to meet compliance requirements? Arbour Group’s fundamentals to change control provides useful tips for managing compliance across the end-to-end supply chain.

Supplier Management & Controls: Fundamentals for the Life Sciences

Friday September 30, 2022

Why is managing supplier controls essential to the life sciences? What do pharmaceutical and medical device companies need to know to meet agency requirements? There are fundamental tips for defining supplier relationships and meeting your goals as a compliant life sciences organization.

The Fundamentals of Test Script Development

Friday September 16, 2022

What is a Validation Test Script, and what does it consist of? Why is it necessary for the Life Sciences validation process? Determine how different test scripts affect various phases of the validation process.

The Fundamentals of Validation Planning

Friday August 12, 2022

What is a Validation Master Plan? Why do organizations in the Life Sciences need a Validation Plan? Discover the purpose and benefits of a VMP that leads the validation process.

The Life Sciences Software Validation Process

Friday April 29, 2022

Explore the software validation process to maintain compliance with regulatory agencies like the FDA and EMA. Arbour Group breaks down what software validation entails in the life sciences, what deliverables are expected, and the benefits of software testing.

Arbour Group’s Pharma 4.0 Insights

Thursday March 31, 2022

Arbour Group divulges the changes, challenges, and benefits of Pharma 4.0 in the Life Sciences Industry.

Software as a Medical Device (SaMD) Compliance Challenges

Monday February 28, 2022

Arbour explores the unique Software as a Medical Device (SaMD) challenges that affect regulatory compliance in the Life Sciences.

Enterprise Resource Planning (ERP) Trends for 2022

Tuesday January 11, 2022

As Enterprise Resource Planning (ERP) evolves, new technologies and processes change. Arbour Group explores the future of ERP systems and how Life Sciences organizations can navigate the evolution of regulatory standards.

Migrating to a Hybrid or Private Cloud

Tuesday November 16, 2021

Cloud Migration to a Hybrid or Private Cloud comes with valuable benefits but also unique considerations. Arbour Group breaks down the challenges while also supporting Life Science companies with sound Cloud Compliance strategies.

Achieving a Balanced Approach to Technology and Total Quality Management Systems Part 2: Quality Investigation and Management

Tuesday October 19, 2021

The second part of a 3-part series addresses Quality and The Role of Risk Management.

Achieving a Balanced Approach to Technology and Total Quality Management Systems

Thursday July 29, 2021

The first part of a 3-part series to address quality control and compliant technology systems with risk-based approaches.

What is Cyber Security and Why is it Important?

Tuesday June 29, 2021

Learn why a sound Cyber Security Strategy with a knowledgeable partner is essential to keep your company safe from cyber threats and attacks.

Reasons Your Company Needs Cloud Compliance

Friday May 7, 2021

Explore with Arbour Group how Cloud Compliance is necessary for your Life Sciences company to meet regulatory standards and thrive in business processes.