Compliance Group

  Bird-brained. Has anyone ever been called that? It’s definitely not a compliment. However, a bird’s eye view is considered good, like being in the crow’s nest or traveling straight as the crow flies. Pretty as a peacock? That’s good too. As I look out my window, the bird songs that abound are enjoyable, and I’m no ornithologist. What do birds have to do with Paperless Validation for the Bio-Sciences? The bio-sciences are all about saving lives, so there’s definitely a connection here. Paper comes from trees, and the more we can go paperless, the more habitats for birds we can save! For those in the bio-sciences, I applaud you. I also applaud those who have created software that allows us to go paperless across many industries. Let’s take a look at some mechanisms that allow for paperless validation. The fundamentals of Good Documentation Practice (GDP) are essential in the industry. Data integrity, arguably the most discussed topic, is the bedrock of GDP in any form of record – p...

Documents and records prove that the company procedures align with compliance and regulation practices while designing, developing, and managing the life sciences products. It is a systematic process of classifying, strong, and retrieving documents with a predefined workflow streamlining the company practices to find information quickly and use the documents effectively, improving the operational performance and regulation practices. For example, for medical device companies, organizing documents and specific information regarding device designs, development processes, manufacturing techniques, procedures, and deviations forms a vital part of the device creation and marketing process. Without that documented information, the company lacks proof of its alignment with FDA (Food and Drug Administration) and ISO (International Standards Organization) regulations. So, from simple procedures to critical design prototypes, document management in a medical device manufacturing company is vital...

  Article Context: Document Control Document Management Document Control-vs-Document Management Information flow is evident in the life sciences industry, resulting in more unstructured data. Therefore, quality data is vital for effective and compliant operations as the industry’s regulations are data-driven. So, there are many documents to be managed and controlled with this. Often, people get confused about these terms – Document Control and Document Management. Though the terms are used interchangeably, there is a considerable difference between them. In this blog, we shall discuss and highlight the differences between document control and document management as they are two distinct aspects and their importance in life sciences organizations. What is Document Control ? Document control is the process of maintaining documents enforcing controlled procedures and practices for creation, review and track document editions and accessibility. That is, it refers to the security and cr...

Computer System Assurance (CSA) is a framework designed to help manufacturers within the Life Sciences industry achieve computer system validation (CSV). CSA clarifies the stance and methodology used to determine what high risk is and what is not, therefore minimizing misinterpretation by manufacturers (fact source –   Computer System Validation vs. Computer Software Assurance (ISPE) . It identifies common pain points; FDA’s current thinking puts patient safety and product quality at the heart of the risk assessment process. When you are in Quality, you have two choices. First, you can decide to continue with no innovation. Second, you and your team can lead by industry regulating standards by having your validation and testing be fun and functional. In the same way, CSA principles align with all Life Science companies.  Computer Software Validation  in pharmaceuticals can be considered an outdated practice. With the rise of CSA, medical device and biotechnology companies...

Companies look forward to increasing their productivity, accomplishing goals, and earning profits. To achieve it, handling business documents and files plays a critical role. When done right with streamlining the process and improving the efficiency of documents, it will enhance success possibilities as improper handling of documents and files leads to loss of critical company information and process deviations. Documents talk about the organization’s procedures, policies, and processes. But, again, consolidating the paper documents, publishing, reviewing them, tracking their progress, validations, and proving their existences and retrieval when required for inspections is not easy. Moreover, complying with regulations handling paper documents is a hectic job. Why is Document Management essential? The FDA (Food and Drug Administration) sends out a Form 483 observation letter seeking evidence of quality processes handled by the organization. If not responded, a Warning Letter is issued,...