Another question that is frequently encountered is “Is the cloud validated?
So Microsoft cannot certify that the Share Point application is TGA or FDA compliant, by simply providing validation documentation to the company.
Usually a regulated company would need their internal QA, validation and IT departments to work closely with a vendor or a Gx P Share Point Consultant.
What the regulatory agencies do expect is that the implementation of the hardware and software by regulated company is done in such a way that the hardware and software is compliant with the CFRs or other regulations.
GAMP 5 provides a useful guidance on how to do this.
It is important to recall that a spreadsheet with GMP impact must be compliant with all regulations like any other system used for GMP purposes.
A not validated spreadsheet or a spreadsheet that is not compliant with respective regulations must not be used for GMP purpose.There is no shortcut on the way to compliance in the validation process of a spreadsheet but we will give you some advises that may ease your work and lower your effort.At the end every spreadsheet is a unique system and the work effort is based on its risk and complexity.This webinar will discuss steps to ensure regulatory compliance and an uninterrupted supply of medical devices in the marketplace, and share insight and best practices from experience in navigating US and global regulations on medical device development - In this webinar, the speakers will discuss how pediatric considerations fit into the overall drug development program and make recommendations for addressing issues from both a practical and scientific perspective - This webinar featuring one of the US’s foremost cancer researchers as the speaker, will discuss cancer as a chronic disease and how researching cancer under this new archetype is adjusting the way in which clinical oncology trials are conducted and how cancer patients are treated - Through a case study with PTC Therapeutics, the speakers will discuss the challenges of entering a new disease area for the first time, the balance of achieving the right size global organization to meet the customer population and the considerations for proceeding independently with a global launch rather than partnering - This webinar will focus on the changing landscape around outsourcing and key reasons why sponsors may wish to take a fresh look at relying solely on the CTMS and RBM systems of their CROs, especially in terms of efficiency - In this webinar, Dr.Tom Snowden will demonstrate why model reduction methods are a potent and necessary tool in the modeler’s arsenal, can be applied to QSP models, and used to extract scientific and business insights from complex models - This webinar will help viewers understand the most recent and significant regulatory shifts in China and Japan including new product classifications, how to successfully prepare for the process of category registration, the best-fit submission framework to reduce development costs and expedite market introduction timelines, and identify the appropriate development strategy for optimal results - In this webinar, the speaker will present vascular and neural complications in rodent models of obesity and type 2 diabetes.Stay aware and informed on essential regulatory requirements, changes, updates, and notices.