The amount of electronic information (data) that computer systems generate continues to grow significantly. Industry is always looking for better, cheaper and faster solutions. Outsourcing to specialized firms that can provide IT solutions more efficiently while leveraging technology to improve information handling, is increasingly more a
The amount of electronic information (data) that computer systems generate continues to grow significantly. Industry is always looking for better, cheaper and faster solutions. Outsourcing to specialized firms that can provide IT solutions more efficiently while leveraging technology to improve information handling, is increasingly more attractive to GxP organizations.
Although the typical cloud application provider tends to have a diverse customer base, that customer base tends to be mostly non-GxP. Additionally, Cloud application providers tend to retain the authority to dictate many of the operational and quality aspects of their GxP cloud applications. With some large cloud providers refusing entirely to provide transparency on processes, procedures, infrastructure and some organizational controls because they are considered to be
"proprietary” information. This does not lend itself to GxP validation principles. Therefore, GxP clients must keep this in consideration when considering 3rd party vendors for outsourcing. Although accountability for compliance remains with the regulated GxP organization, compliance controls may be delegated to others with appropriate management controls in place.
If you are looking to leverage cloud-based applications within your GxP organization, please allow Ganapati Solutions to help you identify and mitigate the potential risks associated with such implementations.
Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality. GAMP 5 ® details a recognized standard for Computer System Validation (CSV).
One of the core principles of GAMP ® is that quality cannot be tested into a batch of
Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality. GAMP 5 ® details a recognized standard for Computer System Validation (CSV).
One of the core principles of GAMP ® is that quality cannot be tested into a batch of product or device, but must be built into each stage of the manufacturing process.
As a result, GAMP ® covers all aspects of production; from the raw materials, facilities and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. Electronic Signatures and Electronic Records (ERES) are also covered in GAMP 5 ®.
Therefore, not only should Life Science organizations follow GAMP 5, but their vendors
should follow the spirit of GAMP 5 ® as well.
Supplier Audits performed by Ganapati Solutions LLC ascertain the vendor's ability to meet computer system best practices.
Life Science organizations are required by regulatory bodies to assume full responsibility for the GxP computer systems utilized by their organization and the GxP data generated as part of their GxP processes.
They are also expected to implement, design, and operate a well documented system that demonstrates a high degree of control base
Life Science organizations are required by regulatory bodies to assume full responsibility for the GxP computer systems utilized by their organization and the GxP data generated as part of their GxP processes.
They are also expected to implement, design, and operate a well documented system that demonstrates a high degree of control based upon a documented risk assessment supported by a sound rationale.
The organizational culture should ensure that the generated data is complete, consistent and accurate in all its forms, i.e. paper and/or electronic.
Ganapati Solutions LLC is well versed in performing Data Integrity audits against the latest Regulatory Requirements and Guidance. If Data Integrity weaknesses are identified, we are able to support the manufacturer to implement the appropriate corrective and preventive actions across all relevant activities and systems to ensure compliance.
Our Data Integrity Audit includes, but is not limited to, the following subject matters:
Additionally Ganapati Solution LLC provides full CSV lifecycle documentation generation and execution, including:
Additionally Ganapati Solution LLC provides full CSV lifecycle documentation generation and execution, including:
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.