Security Solutions
Compliance as a Service
GXP Compliance
Brief Overview
GXP compliance refers to adherence to a set of quality guidelines and regulations following pharmaceutical, medical device, and food and beverage quality standards. These principles ensure high-safety product manufacture, testing, and distribution. GXP compliance applies to food and pharmaceutical manufacturers' norms and regulations. It applies to medical software too. The GXP framework assures food and drug safety. It also ensures product data correctness and dependability. The FDA sets GXP requirements to ensure the safe research and manufacture of medical devices, medicines, biologics, and other food and medical products.
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By 2026, 80% of firms will allocate resources to implement data privacy solutions.
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According to a survey, 83% of risk and compliance professionals emphasized the importance of maintaining compliance inside their firm while making decisions.
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A majority of company executives, namely 73%, acknowledge that cyber and privacy rules are successful in mitigating the cyber threats faced by their firms.
What is the exact scope of GXP compliance?
Good Manufacturing Practice (GMP)
Good Laboratory Practice (GLP)
Good Documentation Practice (GDP)
Good Clinical Practice (GCP)
Difficulties Presented by Regulated Workloads in the Public Cloud: Compliance and Security Silos
Research and Development
Stunted old infrastructure, workloads, and assets.
Clinical trials
Regulatory and compliance standards are strict.
Manufacturing and Distribution
Ineffective compliance management monitoring and tracking in supply chain operations.
Post-Market Surveillance
Safe product use, secure usage, and recalls.
Customer/Patient Results
Gaps in data protection, governance, and compliance.
How does Bizionic ensure compliance with GxP regulations?
The life sciences sector has consistently used cloud technology to ensure the dependable, scalable, and secure operation of their highly regulated IT systems. Bizionic Technologies offers tailored cloud infrastructure configurations (public, private, hybrid, or multi-cloud), migration and modernization services, and managed services. Bizionic Technologies specifically designs these services to help businesses efficiently run their highly critical workloads in the cloud, including computerized systems that enable GxP compliance.
Bizionic specializes in configuring, modernizing, and managing highly scalable cloud computing systems across any cloud infrastructure. Our services provide high availability and reliability, offering a comprehensive suite of tools to support a diverse variety of applications. Ensuring the secrecy, accuracy, and accessibility of our customers' systems and data is a top priority for Bizionic, as is retaining client trust and confidence.
Bizionic Managed Compliance Services provide visible benefits for regulated GxP cloud workloads.
Bizionic provides a cutting-edge GxP compliance solution that expedites the transfer and administration of your regulated workloads to any type of cloud (public, private, hybrid, and multi). Bizionic caters to SaaS, PaaS, and IaaS, which respectively refer to business applications, cloud services, and global infrastructure. By leveraging Bizionic's specialized knowledge in life sciences, adopting a factory-based approach to cloud implementation, and utilizing their managed services, you can efficiently establish a framework that complies with GxP regulations.
Uninterrupted adherence to cloud compliance regulations
Minimize your exposure to compliance risks and attain ongoing cloud compliance by utilizing Bizionic's comprehensive architecture and specialized tools designed specifically for Azure, AWS, GCP, OCI, Bizionic public cloud, and private cloud environments.
Cloud Journey Assessment
By identifying key business initiatives that cloud technology can achieve and utilizing Bizionic's cloud assessment workshops, you can accelerate your transition to the cloud.
Adoption of cloud computing
Facilitate the rapid implementation and acceptance of cloud and business apps using pre-designed solutions based on the most effective methods used in the health sciences industry.
Cloud Adoption Framework
A factory approach based on the Cloud Adoption Framework facilitates the migration of regulated workloads. Compliance-as-a-service is a packaged solution provided as a service, aiming to reduce obstacles to compliance and innovation in a cost-effective manner.
Value generation
Direct your attention towards tasks that generate value rather than ones that deplete value.
Bizionic provides comprehensive managed compliance and
compliance-as-a-service solutions.
IRAP
Based on Australian security laws and standards, the Information Security Registered Assessors Program (IRAP) provides a comprehensive framework for assessing, analyzing, and evaluating the effectiveness of an organization's cybersecurity measures. The Australian Signals Directorate (ASD) monitors this.
BANK NEGARA
Bank Negara Malaysia (BNM) oversees a significant regulatory framework and rules that specifically address operations in the banking, financial services, and insurance (BFSI) sectors.
THE CENTRAL BANK OF OMAN
The Central Bank of Oman has implemented regulations that apply to all functions in the banking, financial services, and insurance (BFSI) sector, as well as banking institutions in Oman.
SAMA
The Saudi Arabian Monetary Authority has implemented a centralized cybersecurity framework and protocols to provide guidance to firms in all industries on how to successfully safeguard their operations, assets, and data.
FINMA
The Swiss Financial Market Supervisory Authority provides regulations and frameworks to oversee banks, financial institutions, insurance companies, stock exchanges, securities dealers, and other entities.
UAE COMPLIANCE
The United Arab Emirates has implemented comprehensive legislation covering data residency, privacy, and other aspects of company operations, ensuring compliance on a wider scale.
GDPR
The General Data Protection Regulation (GDPR) is a comprehensive set of legislation that governs the acquisition and use of personal data by persons who are European Union residents.
PCI-DSS
The Payment Card Industry Data Security Standard establishes guidelines and standards to guarantee that all businesses involved in taking, storing, and processing credit card information maintain a highly secure environment.
HIP-AA
The Health Insurance Portability and Accountability Act establishes standards and protocols to guarantee the confidentiality, protection, and accuracy of sensitive patient data. Healthcare firms obtain the HITRUST (Health Information Trust Alliance) accreditation as evidence of their compliance with HIPAA regulations.
ISO STANDARDS
Compliance requirements for operations in the banking, financial services, and insurance (BFSI) sector, as well as for financial institutions, pertain to matters such as security, operational management, and data administration. The Reserve Bank of India, the leading banking institution in the country, provides these compliance requirements.
MAS
The Monetary Body of Singapore, which is the country's central body for banking, financial services, and insurance, has established guidelines for financial institutions outsourcing operations and procedures.
OJK
The Financial Services Authority of Indonesia (Otoritas Jasa Keuangan) issues and oversees the regulations governing the management and operations of financial institutions.
RBI
Compliance requirements for operations in the banking, financial services, and insurance (BFSI) sector, as well as for financial institutions, pertain to matters such as security, operational management, and data administration. The Reserve Bank of India, the leading banking institution in the country, provides these compliance requirements.
GXP
The GXP compliance standard is an abbreviation for regulatory criteria and recommendations that are applicable to many industries, such as life sciences, food, and medical items. The 'X' in GXP represents any letter that is relevant to a certain industry. Examples of these practices are good laboratory practices (GLP), good clinical practices (GCP), and good manufacturing practices (GMP).
An Impact with Difference:
Why Partner with Bizionic for
Enterprise Cybersecurity Transformation?
One of the top managed cybersecurity firms and the biggest application-focused managed cloud services provider in the world.
Pre-met standards for local, national, and international compliance, such as ISO, CSA, GDPR, HIPAA, SAMA, IRAP, and GXP certifications.
Seven Frameworks for Security Making use of CIS Critical Security Controls, MITRE ATT&CK, and other.
Extensive round-the-clock cybersecurity surveillance program.
Advanced Managed Detection and Response Solutions (MDR) are automated security solutions for threat prediction, detection, and response.
International proficiency in solutions and services for managed Security Operations Centers (SOCs). environments by integrating security and operations teams.
A portfolio devoted to DevSecOps.
Comprehensive end-to-end IT and cloud stack cybersecurity consulting, assessment, and audit reporting services.
The Cybersecurity Incident and Response Team (CSIRT) for Advanced Bizionic Solutions.
Significant experience in threat management in securing large and complex environments.
Comprehensive expertise in publicly managed cloud security services: AWS, Azure, GCP, and Oracle Cloud.