Tuesday April 26, 2016
What is SAP?
SAP, started in 1972 by five former IBM employees in Mannheim, Germany, states that it is the world's largest enterprise software company and the world's fourth-largest independent software supplier overall. SAP is headquartered in Walldorf, Baden-Württemberg, Germany, with regional offices in 130 countries. The original name for SAP was German: Systeme, Anwendungen, Produkte, which translates to "Systems Applications and Products" in English. The original SAP idea was to provide customers with the ability to interact with a common corporate database for a comprehensive range of applications. Gradually, the numerous other applications have been developed and today many corporations, including IBM and Microsoft, are using SAP products to run their own businesses.
The SAP 5 year Outlook
In 2015 SAP provided its five year outlook and projects that its cloud business will “deliver more growth and ultimately boost profits with a more predictable revenue stream.” They also stated that its cloud and support revenue will be very similar to its software business by 2017 with the hopes of it being passed in 2018. By 2020 they predict that the cloud revenue will be extremely high and will lead to more predictable sales.
What does this mean for client users?
There many advantages and some disadvantages to cloud computing. The term cloud computing itself means being able to access, process, and manage various recourses and data by using system of remote servers hosted on the Internet. Cloud computing can provide new ways for companies to use technology that will help them to serve their supplies, partners, and customers. Some of the advantages include:
- Backup and recovery
- Data sharing
- Cost efficacy
The cloud can also store many more forms of data with its unlimited storage capacity.
Cloud computing services are also able to be accessed through almost any electronic device, as it is device-independent. With all of these advantages, it does have its disadvantages. Some of these disadvantages include:
- Data breaches
- Data loss
- Account or service traffic hijacking
- Lack of transparency and liability
- Cloud abuse
If you are wondering whether or not cloud computing is right for your company, use the Pareto Analysis with the principle of the “80/20” Rule, in which 20 percent of the causes would result in 80 percent of the work generated.
What are the regulatory compliance implications?
Responsibility for regulatory compliance in a cloud environment remains with the customer. Cloud applications, like the on premise counterparts, contain data that is relied upon for decisions related to product quality and efficacy. Consequently, the burden to demonstrate that a validated state has been achieved and maintained continues, to include the infrastructure component.
Regulated software applications in a cloud environment must be validated for their intended uses and maintained under a documented Change Control procedure. Since the infrastructure component is not directly controlled by the client, reasonable measures must be taken to assure proper access control, data security and infrastructure control. Infrastructure compliance is achieved by an audit of the cloud providers, i.e., software developer and host (data center) provider, wherein the policies, procedures and practices are reviewed for 21 CFR Part 11 compliance. Periodic Reviews of cloud providers is also recommended.
Arbour Group has pre-packaged validation solutions for SAP cloud applications that significantly reduce the cost and effort of software validation. These pre-packaged solutions are based on extensive industry knowledge and expertise from years of exclusively focusing on the life sciences industry. Additionally, we can provide the audit services required to assure that the appropriate documented evidence is in place that meets regulatory requirements.
The Arbour Advantage
Arbour Group is a trusted regulatory advisor to over 250 pharmaceutical, medical and healthcare companies worldwide. Let us demonstrate how we can become a valuable business partner and deliver effective products and services that reduce the cost of compliance. If you have any questions, feel free to contact us and we will be in touch!