What is GxP?
What is GxP? GxP are the quality standards and regulations for a specific field or activity. GxP revolves around two main regulatory pillars: accountability and traceability. Accountability refers to the ability to demonstrate what each person has contributed to a product or project and when they contributed it. Traceability means that there needs to be a way […]
Your guide to 21 CFR Part 11 compliance
For life science companies, 21 CFR Part 11 compliance has always been a challenge. While using a cloud-based quality management system helps streamline compliance processes by allowing for digital signatures, organizations must be sure to tick all the boxes when it comes to complying with stringent FDA guidelines. 21 CFR Part 11 is an FDA […]
What is ISO 9001?
ISO 9001 Meaning In a nutshell, ISO 9001 is the standard outlining the requirements an organization’s quality management system must meet or exceed to be certified. To give you a bigger picture, the ISO 9001 standard is one part of the group (or “family”) of ISO 9000 standards. This ISO family is focused on quality […]
Adaptation is your key to QMS adoption
When I talk with people about their Quality Management System (QMS), or their plans to invest in one, I’m often asked about who would be best to estimate the risk of change. This is especially important when people are making changes to Quality System Documents. It always makes me think of Darwin’s finches, a set of 13 different […]
What is QMS?
The term Quality Management System (QMS) refers to the management practices within organizations that ensure high standards of quality for their customers. The term is frequently used in Manufacturing and Life Sciences industries and is essential for companies who seek to obtain quality certifications, such as ISO 9001 or GxP (including GMP, GCP, GLP, and more), or adhere to compliance requirement imposed by their industry, […]
Where do quality management and safety management systems intersect?
When organizations start talking about Quality Management Systems (QMS) and then the conversation moves into Safety Management Systems (SMS), many will do a double-take and wonder “Hey… Wait a minute, aren’t these the same thing?” While there are some commonalities, the QMS and the SMS have very different objectives: QMS = Focused on delivering quality to satisfy the […]
SOC 2 certification is crucial for document security in the cloud
We are proud that AODocs has an SSAE 16 SOC 2 certification. What is SSAE 16 SOC 2 Certification? SSAE 16 is an auditing standard that verifies controls and processes. It also requires a written report regarding the design and operating effectiveness of the controls being reviewed. The resulting report is one of the gold standards of […]
The shortest path to QMS adoption is though QMS adaptation
Adoption is one of the key aspects of any QMS program. After all, if people resist using it, or are not using it properly, your Quality Management System is likely to fail. With that in mind, it’s strongly advised that you make participants aware of the importance of the costs and ramifications when quality is absent from […]
QMS: calculating the cost of quality
The Cost of Quality (CoQ), also known as Quality Costs, is the cost related to the number of resources used to maintain the quality of products. It also includes the costs associated with detecting, correcting, and preventing issues with the product, both internally and externally. Quality costs can occur anywhere in an organization, so it’s […]
