What is GxP Compliance: Brief Overview
GxP compliance basically refers to the guidelines and regulations that are applicable to food and drugs manufacturing organizations. It also applies to medical software applications. The GxP framework ensures that medical and food products are safe for consumption. It also helps to ensure the integrity of data utilized in product manufacturing. GxP guidelines are established by the US Food and Drug Administration (FDA) and exist to ensure safe development and manufacturing of medical devices, pharmaceuticals, biologics, and other food and medical product industries.
GxP consists of a wide range of compliance activities that include Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and more. The practice guidelines and regulations are implemented based on product type (medical devices and software) and the country in which the product would be sold. Life sciences organizations and food and drug administration performing GxP activities for quality management using computerized systems must ensure comprehensive data security.
By 2026, 80% of businesses will invest in solutions dedicated to safeguarding data privacy
83% of risk and compliance professionals said that keeping their organization compliant is essential in its decision-making processes
73% of organization leaders agree that cyber and privacy regulations are effective in reducing their organizations' cyber risks
What Does GXP Compliance Exactly Cover?
Good Manufacturing Practice (GMP)
Good Laboratory Pratice
(GLP)
Good Documentation Practice
(GDP)
Good Clinical Practice (GCP)
Challenges of Regulated workloads in Public Cloud:
Security and Compliance Silos
Research and Development
Stunted legacy
infrastructure and
workloads, assets
Clinical
Trials
Strict regulatory
and compliance
requirements
Manufacturing
and Distribution
Inefficient monitoring and
tracking of compliance
management across
supply chain activities
Post Market
Surveillance
Product safety,
secure usability, and
product recalls
Customer/Patient
Outcomes
Data security
loopholes and data
governance,
compliance gaps
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How Cloud4C ensures GxP compliance?
It is not news that the life sciences sector has steadily increased the use of cloud technologies for highly reliable, scalable and secure solutions to operate their highly regulated IT systems. Cloud4C configured cloud infrastructure (public/private/hybrid or multi cloud), Migration and Modernization processes as well as Managed Services are designed to help customers run their most sensitive workloads in the cloud, including the computerized systems that support GxP.
Cloud4C configures, modernizes and manages scalable cloud computing platforms on any cloud with high availability and dependability, providing the tools that enable you to run a wide range of applications. Helping to protect the confidentiality, integrity, and availability of our customers' systems and data is of the utmost importance to Cloud4C, as is maintaining customer trust and confidence.
Regulated GxP workloads on Cloud: Visible Benefits of Cloud4C Managed Compliance Services
Cloud4C offers an innovative GxP compliance solution to accelerate migration and management of your regulated workloads to any cloud (public, private, hybrid and multi). Cloud4C addresses SaaS (business applications), PaaS ( cloud services) and IaaS (global infrastructure). By leveraging Cloud4C expertise in life sciences, factory based approach to cloud adoption and managed services, you can rapidly implement a GxP compliant framework.
Reduce your compliance risk and achieve continuous cloud compliance with Cloud4C’s framework and accelerators built for Azure, AWS, GCP, OCI, Cloud4C public cloud and private cloud.
Accelerate your cloud journey by identifying strategic business initiatives made possible with cloud leveraging Cloud4C’s Cloud assessment workshops.
Accelerated deployment and adoption of cloud and business applications with pre-packaged solutions built-on life sciences best practices.
Cloud Adoption Framework based factory-approach to migrate regulated workloads
Cost-effective bundled solution offered as a service to minimize barriers to compliance and innovation
Focus on value creating activities rather than value consuming activities
Cloud4C End-to-end Managed Compliance and Compliance-as-a-Service Offerings
With Cloud4C’s dedicated Compliance-as-a-Service or Managed Compliance offerings, enterprises can augment their IT infra, cloud landscapes, architectures, systems, and applications to be fully compliant with different regulations and standards. Cloud4C’s global acumen paired with world-class compliance experts and state-of-the-art technologies duly investigate customer landscapes, assess functionalities and workloads to verify whether the same are compliant with the concerned protocol or not, delivering strategies and implementing the necessary procedures to ensure that companies across the globe operate risk-proof.
We are adept in all major cloud services certification program initiatives. Be any hyperscaler cloud landscape, on-prem systems, private cloud ecosystems, third-party environments, or remote edge ecosystems, Cloud4C’s managed compliance services cover it all and help organizations be compliance-ready end-to-end.
IRAP
Information Security Registered Assessors Program or IRAP concerns a set of security protocols and frameworks to audit, analyze, and measure cybersecurity efficiency of an organization basis Australian security requirements and standards. This is monitored by the Australian Signals Directorate (ASD)
Bank Negara
A major compliance framework and regulations catering to BFSI activities and banking institutions monitored by Bank Negara Malaysia (BNM)
Central Bank of Oman
Regulations certified by Central Bank of Oman catering to all BFSI functions and banking institutions in Oman
SAMA
Centralized cybersecurity framework and processes regulated by Saudi Arabian Monetary Authority to guide organizations across all industries to effectively protect their operations, assets, and data.
FINMA
Regulations and frameworks offered by the Swiss Financial Market Supervisory Authority to supervise banks, financial institutions, insurance companies, stock exchanges, securities dealers, etc.
UAE Compliances
Broader UAE compliances regarding data residency, privacy, and other regulations governing enterprise functions in the United Arab Emirates.
RBI
Compliance regulations for BFSI activities and financial institutions concerning security, operational management, data administration, etc. Delivered by the Reserve Bank of India, the nation's premier banking organization.
MAS
Guidelines issued by the Monetary Authority of Singapore, the nation's central BFSI authority on outsourcing operations and processes of financial institutions.
OJK
Regulations issued and monitored by the Financial Services Authority of Indonesia (Otoritas Jasa Keuangan) on the functioning and operations of financial institutions.
GDPR
General Data Protection Regulation is a set of advanced regulations governing the collection and usage of personal data from individuals residing in the European Union.
PCI-DSS
The Payment Cards Industry Data Security Standard sets frameworks and benchmarks to ensure that all enterprises engaging in accepting, storing, processing credit card data maintain a highly secure environment.
HIPAA
Standards and frameworks set by the Health Insurance Portability and Accountability Act to ensure the privacy, security, and integrity of sensitive patient information. The HITRUST (Health Information Trust Alliance) certification is garnered by healthcare companies as proof that they comply with HIPAA standards.
GXP
The GXP compliance standard is an acronym for regulatory requirements and guidelines applicable for the broader life sciences, food, and medical products, etc (The 'X' stands for any letter applicable vertical-wise). For instance, Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP).
ISO Standards
Introduced by the International Organization for Standardization, these frameworks certify the global standard requirements applicable to any offering or service. The number after an ISO refers to the concerned category: ISO-27001, ISO-27017, ISO-27018, ISO-22301, ISO-20000, etc.
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An Impact with Difference: Why Partner with Cloud4C to become Industry Compliant?
World’s largest Application-focused Managed Cloud Services Provider and one of the leading managed cybersecurity companies. Dedicated cybersecurity assessment services.
Serving 4000+ enterprises including 60+ Fortune 500 organizations in 25+ countries across Americas, Europe, Middle East, and APAC for 12+ years
40+ Security Controls, 20+ Centres of Excellence, 2000+ global cloud experts
One of the most trusted managed compliance companies with pre-met compliance needs for local, national, and global compliance requirements including IRAP, GDPR, HIPAA, SAMA, CSA, GXP, and ISO Certifications
3200 UTMs, 13000 HBSS, 800000 EPS
7 Security frameworks utilizing the MITRE ATT&CK, CIS Critical Security Controls, and more
Experience in managing compliance requirements for multiple OEMs with modernized security and governance offerings
Automated Security Solutions for threat prediction, detection, and response: Advanced Managed Detection and Response Solutions (MDR)
Global expertise in managed SOC (Security Operations Center) services and solutions
Dedicated Cybersecurity and Compliance Consulting, Cybersecurity Assessment, and Audit Reporting offerings leveraging advanced automation solutions
Advanced Cloud4C Cybersecurity Incident and Response (CSIRT) team
Threat Intelligence powered by Industry-leading platforms such as Microsoft, OSINT, STIX&TAXI, MISP, etc., and Cloud4C Threat experts
Considerable threat management expertise in securing large and complex environments and using advanced functionalities of leading industry tools as well as Cloud-Native Security tools
Experience in deploying and managing robust SIEM – helping enterprises to proactively assess vulnerabilities and automate, accelerate incident response
Comprehensive expertise in managed public, private, hybrid, and multi-cloud governance and risk compliance services, especially powered on AWS, Azure, GCP, Oracle Cloud, IBM Cloud, etc
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