Cloud computing is not a new technology, but a new way of providing resources for data processing.
"Cloud computing is a model that makes it possible,
on demand,
按需
anytime, anywhere and conveniently via a network
随时随地、方便地通过网络
to access a shared pool of configurable computing resources (e.g. networks, servers, storage systems, applications and services),
访问可配置计算资源(例如网络、服务器、存储系统、应用程序和服务)的共享池
that can be rapidly provisioned and with minimal management effort or service provider interaction“.
It is useful to initially think of a "cloud" first as a data centre, i.e. a third-party data centre. However, a regulated company has the same responsibility for the compliant operation of computerised systems as it does in its own data centre – only now the infrastructure and data are located elsewhere.
In principle, the control or management of the data is entrusted to the cloud provider, while the responsibility remains with the pharmaceutical manufacturer. From the perspective of a GMP regulated company, this immediately raises questions about:
data security,
数据安全
data availability and
数据可用性
data integrity.
Public Cloud
公共云
Community Cloud
社区云
Private Cloud
私有云
Virtual Private Cloud
虚拟私有云
Hybrid Cloud
Then there is the type of service model, and this is where things get a bit complicated. Let me just pick out the most common acronyms:
IaaS——基础设施即服务
This is a computer infrastructure that is provided and managed via the Internet. Companies utilise the computing capacities and pay for the use of the computing power.
PaaS——平台即服务
Here, the company rents a complete operating system or a development environment. The customer is responsible for the applications running on it.
SaaS——软件即服务
Finally, the user company is only responsible for the customer-specific data and access. Many people are familiar with this from SAP or accounting programmes.
As you can see, things were different 10 years ago, and software often even had to be installed on a PC in the company. Today and in the future, we will only access the resources provided. This is also called division of labour – why should a pharmaceutical company be so deeply involved in IT issues when its core competency is drug production?
Cloud-based services are used extensively in private areas (social media, online shopping) and are widely used in retail, banking, entertainment, etc.
These are seen as advantages:
Cost savings
节约成本
Speed
速度
Flexibility
灵活性
Security
On the other hand, there are disadvantages that can arise in unfavourable cases:
Penalties
罚款
Downtime
停机时间
Loss of sales
销售损失
Damage to reputation
声誉受损
Loss of customer confidence
However, it is important to remember that when companies decide to keep all applications and data in-house, most of these risks are still present and need to be managed with in-house expertise.
Professional cloud services already cover these risks.
Expertise is always a key factor in the decision to outsource or insource. How much does external or internal expertise cost? The premise of division of labour also applies here.
撰稿人 | GMP-Verlag Peither AG
责任编辑 | 胡静
审核人 | 何发
2024-07-16
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本文的目的是为了探讨不同清洗方法对分装器具的清洗效果。通过选取合适的污染物,以人工模拟污染的方式来污染各种直接接触产品的分装器具,然后对手工清洗、机械清洗的清洗流程以及清洗后取样检测总有机碳 (TOC)、电导率、细菌内毒素和微生物限度这 4 项指标进行比较分析。得出的结论为机械清洗的方法更具优越性,不仅提高了分装器具灭菌的质量,也降低了分装器具发生污染及交叉污染的风险。
作者:程露露 李欣
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