20 de February de 2024

What does ‘rollout’ entail? This covers the overall strategy, helpful tips, and ways to leverage documentation from another unit within the company for maximum benefit.

31 de January de 2024

Validation Principles – Collaborative Validation and Third-Party Support

Welcome to our blog! In this session, we will explore the vital role of suppliers and their collaboration with regulated companies, as well as delve into the world of third-party validation processes.
10 de November de 2023

Navigating the Regulatory Challenges of Medical Devices and Health Tech Startups: Embracing Agile and Digital Validation for Faster Time-to-Market

A startup's path to growth involves numerous obstacles and stages, particularly for those operating in regulated markets such as Medical Devices and Health Tech.
23 de October de 2023

The Responsibilities of the Life Sciences Industry Supplier

Validation is a documented process to prove that equipment, systems, spreadsheets, processes, and procedures work safely and efficiently to protect patients and clients, and to ensure product quality and data integrity.
21 de June de 2023

Maintenance of Systems’ Validated Status: A Major Challenge for Life Sciences Companies

Life Sciences companies face several challenges in developing and keeping their systems updated.
31 de March de 2023

GAMP5® 2nd edition and CSA FDA: Why they can be good for business.

Some important points that the second edition of GAMP5® and CSA bring and make us think about ‘how system validations will be from now on.
29 de March de 2023

SAP® Solution Manager, SAP® ALM, and GO!FIVE® are equivalent tools to validate SAP?

Many Life Science companies (Pharmaceuticals, Medical Devices, Biologics, and Diagnostics) use the SAP® platform as ERP (Enterprise Resource Planning) to manage their data and processes in an integrated way.
22 de March de 2023

ISO 17025:2017 General Requirements for the Competency of Calibration and Testing Laboratories

ISO (International Organization for Standardization) is a worldwide organization composed of collaborating groups in more than 160 countries.
10 de March de 2023

How to apply Knowledge Management – KM in validation

Knowledge Management is the process of capturing, distributing, managing, and effectively using knowledge and information within an organization.
27 de February de 2023

Business Intelligence Systems – BI: how and when validating

As we know, nowadays companies need to have a clear data overview to remain competitive, whether for their projections, risk assessment, and/or opportunities.
22 de February de 2023

After data integrity, Governance.

The integrity of critical data in Life Sciences industries is an issue that, if taken with the care deserved and required by regulatory agencies, keeps the company aligned with Good Manufacturing Practices and avoids issues detrimental to the production process and business.
23 de January de 2023

Performing Digital Validation Manually and the Risk to Data Integrity

The need for remote work increased exponentially during the pandemic. Many industries had already embraced digitalization, but the pandemic forced companies and professionals to adapt more quickly.
19 de January de 2023

Verification & Validation – V&V

Verification is a process that determines the quality of a product. This step includes all the activities associated with high-quality production, (i.e., testing, inspection, design analysis, specification analysis, etc.).
27 de December de 2022

ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management.

Using a Waterfall model is a very common practice for project delivery of paper-based validation, or validation using a text editor.
27 de December de 2022

Industrial Automation Projects

Industrial automation is defined as the use of equipment, hardware, and specific software to automate an industrial process: whether production optimization; control and traceability; monitoring; analysis performance and tracking; among others.
5 de December de 2022

Validation Using a Text Editor

Validation Using a Text Editor (e.g., Microsoft Word) is One of The Biggest Bottlenecks in The Regulated Industry.
5 de December de 2022

Requirements Management vs Validation Lifecycle Management

Although it seems at first that a Requirements Management System (RM) and a Validation Lifecycle Management System (VLMS) are similar, the RM has a limited scope in relation to VLMS conformity.
9 de September de 2022

Change from paper to SaaS platform: now is the time!

Activities and changes in consumer behavior are proving that it’s only a matter of time before the use of paper is obsolete.
22 de August de 2022

Cloud Computing Validation in a Regulated Environment

Cloud Computing plays an essential role in the digital revolution that most companies are now experiencing.
12 de July de 2022

Get Your Data Integrity Basics Down for Success

This article was written by Silvia Martins and disclosed by PDA (Parenteral Drug Association). Read more.