Good practice quality guidelines (GxP) have risen in significance for life sciences industries and several other regulated industries notably medical device manufacturers. Broad motivations undoubtedly rely on meeting regulatory guidelines and cost-cutting pressures to maintain profitability. Clinical trials and various areas of drug research and development are subject to intense regulatory onslaught.
This creates the need for dedicated IT infrastructure that will help life science companies in meeting ever-changing compliance as is evident in good automated manufacturing practice (GAMP). In this backdrop, organizations have shown considerable interest in deploying cloud in GxP environments. The market for GxP compliant solutions draws strength from this trend.
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All cloud services share the characteristic for pay-what-you-use, which is one of the key propositions in the growth of the GxP cloud compliant market. Life science companies are focused on leveraging the unparalleled agility and scalability of GxP cloud compliant solutions in overcoming the limitations of internal systems. Increasing industry efforts to simplify cloud deployment models are boosting the adoption of GxP cloud compliant solutions. In recent years, pharmaceutical and biotech companies are utilizing an array of toolsets offered by technology companies in meeting GxP compliance regulations, notably those put forth by the U.S. Food and Drug Administration. Various solutions launched in recent years stress on patient safety and privacy and integrity of data stored in GxP cloud. A case in point could be New Azure by Microsoft and AWS by Amazon. A growing number of companies being GxP compliance ready is boosting the market. A growing number of biotech and pharmaceutical companies being GxP compliance ready will expand the potential of the market.
GxP Cloud Compliant Market Overview
GxP is a term used to refer to any good practice quality regulations and guidelines. The x can be substituted for many fields like pharmacy, the food industry and even the Information technology industry while GP stands for good practices. The main purpose of these guidelines is to ensure that the product is safe and meets its stated purpose of use. The most important aspects of GxP are the ability to reconstruct development history of a medical device or drug i.e. traceability and the ability to resolve each individual’s contribution to the development of a product or service i.e. accountability. With all the crucial data of companies and individuals moving to the cloud in the 21st century, the GxP Cloud Compliant Market is gaining increasing importance.
One can scarcely imagine the consequences if confidential cloud data gets hacked, stolen or even replicated without consent. Companies could fall into trouble during security audits if they cannot provide evidence of a validated and secure IT infrastructure. This is particularly true for highly regulated fields like food, medical devices, drugs and cosmetics. Inaccurate or incomplete data can have devastating effects on customer safety and lost or incomplete data can seriously harm the organisation goodwill and financial stability. The GxP Cloud Compliant Market helps ensure that critical cloud data is accurately stored, easily accessible and consistently modifiable.
GxP Cloud Compliant Market Restraints
Despite the many advantages of cloud computing, there are still numerous restraints in the GxP Cloud Compliant Market. Some of them are –
Risk aversion towards computerized compliance – Industries like pharmacy or the food industry are very risk averse when it comes to computer systems and compliance requirements. They might hesitate in adopting cloud technology in their organisation entirely. This mind-set must be overcome if they wish to progress and evolve with the changing times. Specific quality or compliance requirements – The life science industry is just one example of an industry with very specific quality or compliance requirements. The GxP Cloud Compliant Market is meant to cater to the broadest possible set of customers which makes it very industry agnostic. The lack of catering to individual client or industry specific compliance needs could hamper the growth of the overall market. Ownership related concerns– Cloud services are usually outsourced to a third party provider. However, the responsibility of ensuring compliance with regulatory bodies lies not with them but the customer. In addition, the customer might not be able to control certain aspects of the cloud even though they still need to make sure that due diligence has been taken and the risk of lack of control is brought down to the minimally accepted level. Privacy issues – The most critical concern of the GxP Cloud Compliant Market is that of privacy issues. Since the cloud is managed by an outside party, companies with confidential or highly critical data may not wish to take advantage of this technology. There have been several cases of cloud hacking which has made them extremely wary about it.
GxP Cloud Compliant Market Key Market Players
Some of the GxP Cloud Compliant Market key market players are ByteGrid, Microsoft Azure, Amazon Web Services, IBM Watson Health Cloud, Verizon Terremark, OPERION, Adobe Document Cloud, and Aurea (NextDocs).
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