Managing Gxp Environmental Systems to Ensure Data Integrity

Total Page:16

File Type:pdf, Size:1020Kb

Managing Gxp Environmental Systems to Ensure Data Integrity WHITE PAPER www.vaisala.com Managing GxP Environmental Systems to Ensure Data Integrity In this paper, we provide some history of data management for life science systems and an overview of new regulatory expectations, including changes to guidance. We then offer eight recommendations for establishing and maintaining good practices for data integrity. More than Bytes and control strategies available Thanks to the publication of and Signatures for compliant data management, enforcement actions such as GMP pharmaceutical companies can find non-compliance reports, warning As efforts to ensure the quality and change hard to achieve, both in terms letters, import alerts, and notices, it’s safety of drugs increase, so does the of updating systems and behavior. evident that regulators are targeting amount of data generated by those data integrity failures during efforts. As a result, global regulatory inspections. Subsequent enforcement scrutiny over the last few years has Enforcement Action actions have led to the withdrawal turned to providing guidance on on Data of supply across multiple markets, preserving data quality. Throughout product recalls, consent decrees and Data integrity requirements have the life science industries — reputational damage for the firms been addressed in the FDA’s Title pharmaceutical research, involved. With increased targeting 21 CFR Part 11 and the EU's GMP manufacturing, medical devices of data integrity from regulators, it is Eudralex Volume 4, Chapter 4 and and biotechnology — guidance and now crucial that everyone involved in Annex 11. This is so far unchanged. regulatory enforcement strategies GxP-regulated activities understand However, with increasing automation are being re-evaluated with a focus correct data management practices. based on computerized systems, as on data integrity. With increasing well as the globalization of operations awareness among inspectorates of and the increasing cost of bringing problems inherent to data collection products to market, new guidance and storage, there comes increased was needed to clarify regulatory awareness of gaps between industry expectations around the creation, practice and existing technology. handling and storage of data. Although there are solutions Principles and Practice The acronym ALCOA is used by the FDA, MHRA, and the World Health Organization to outline expectations on records, including paper-based, Data integrity means that all data electronic, and hybrid (systems that use both paper and electronic records). collected and stored must be correct, ALCOA is a useful guide to remembering key points of data management for GxP traceable and reliable. In the UK the compliance. ALCOA means: Medicines and Healthcare products Regulatory Agency (MHRA) defined data integrity in their 2015 document: “MHRA GMP Data Integrity Definitions A = Attributable to the person generating the data and Guidance for Industry” as the L = Legible and permanent extent to which all collected data are = Contemporaneously recorded “complete, consistent and accurate C throughout the data lifecycle.” O = Original or a true copy A = Accurate For their 2016 draft guidance for industry “Data Integrity and Compliance with CGMP” the FDA The WHO added some extra definitions to ALCOA in their document “WHO defines it as: “…the completeness, Technical Report Series 996 Annex 5*, Guidance on good data and record consistency, and accuracy of data. management practices” expanding the acronym to ALCOA+. In addition to Complete, consistent, and accurate original emphasis of ALCOA principles, the “+” includes the attributes of being data should be attributable, legible, complete, consistent, enduring and available. contemporaneously recorded, original or a true copy, and accurate (ALCOA).” Thus, ALCOA+ is now the goal for every piece of information that can impact the purity, efficacy and safety of products, and the standard by which data will Full documents: MHRA GMP Data Integrity be evaluated. In practice it means that companies must maintain control over Definitions and Guidance for Industry* and intentional and unintentional changes to data, including the prevention of data Data Integrity and Compliance with CGMP* loss or corruption. Data Management However, a review of enforcement actions proves that many companies are Challenges misinterpreting guidance. Other industry stakeholders try to help with more explicative documents. For instance, the European Compliance Academy (ECA) Regardless of the methods of published an article specifying data integrity failures that caused one German gathering and storing data — manual, company to receive an FDA Warning Letter. Observations included: automatic or a combination — there ▪ Failure to exercise sufficient controls over computerized systems to prevent are opportunities for failure. Manual unauthorized access or changes to data, and to provide controls to prevent processes entail obvious points omission of data. of possible failure: operators can The computerized system lacked access controls and audit trail capabilities. forget to record information, record ▪ incorrect values, lose records, or ▪ All employees had administrator rights and shared one user name. even intentionally falsify data. The ▪ Electronic data could have been manipulated or deleted without traceability. risks with computerized systems ▪ Raw data were copied to a CD and then deleted from the hard drive. Data are more technical. For both copied were selected manually without assurance that all raw data was copied manual and automated methods, before being permanently deleted. regulatory agencies have described the regulatory expectations in their Each of these deviations could have been addressed by systems and methods guidelines and draft documents. including: ▪ Unique usernames and passwords Full document: WHO Technical Report ▪ An inerasable audit trail or event log Series 996 Annex 5, Guidance on good data and record management practices* ▪ Separate administrator and user access rights ▪ Good standard operating procedures (SOPs) Oversight and regular review of processes * See references at the end of this paper for links to sources. ▪ From Principles to Practicable There are seven functions and knowledge areas touched upon consistently in regulations and guidance on data integrity. Here we review these key areas, focusing on how they are applied to environmental monitoring applications. Quality Risk Management1 Personnel2 Documentation ▪ Understand the potential ▪ Document and communicate ▪ Implement Good impact of all data on product roles and responsibilities. documentation practice quality and patient safety. ▪ Provide technical support for (GdocP) in all written ▪ Understand the basic systems administration. documents and SOPs. technologies used in your ▪ Assign responsibility for data ▪ Refer to relevant regulations data processes, and their throughout its entire lifecycle. when creating and reviewing inherent limitations. documents. For example, ▪ Encourage a workplace culture CFR Title 21, Part 211 “Current ▪ Implement systems that that supports issue reporting. provide an acceptable state Good Manufacturing of control that is matched to ▪ Implement systems that Practice for Finished process criticality and risks. can identify and minimize Pharmaceuticals” Subpart J - potential risks. Records and Reports. ▪ Identify and document points of risk for unauthorized ▪ Create behavioral controls for deletion or amendment, as well personnel, procedural controls as opportunities for detection for processes, and technical Data Life Cycle through routine reviews. controls for technologies. Implement change Schedule and perform Reward proper conduct and ▪ ▪ ▪ management and control of periodic risk assessments. analyze the root causes of compliance failures in order to incidents and deviations. Provide training to ensure you ▪ fix them systemically. Ensure corrective and are using existing technologies ▪ preventive action (CAPA) to their full potential. ▪ Authorize individuals and grant appropriate privileges processes and procedures are for each system. in place. Audits & Internal Inspections3 Training Vendors/Providers ▪ Create detailed review ▪ Provide regular training, and ▪ Ensure providers have qualified processes for inspection document training completion and trained personnel. including personnel identities findings, non-compliance Review providers’ quality and dates. ▪ reports, and Warning Letters. management systems. Ensure training is matched ▪ Perform routine in-house data ▪ Note compliance to standards to different roles involved ▪ audits, including: audit trails, such as ISO 9001, or ISO 17025. raw data and metadata, and with data, including quality original records. assurance, quality control, ▪ Perform regular checks production and management. of providers’ systems ▪ Schedule regular spot-checks and services; audit where Store training documentation of system user access rights. ▪ necessary and/or allowable. where it is quickly retrievable Report audit results to senior ▪ by those involved with Review contracts, technical management and other ▪ regulatory and 3rd party agreements, quality relevant stakeholders. inspections. agreements. 1 A key document in this area is ICH Q9. This guideline from the ICH Expert Working Group provides a methodology for a risk-based approach to data management, including recommendations. See references at the end of this paper for links to sources. 2 Personnel management directs and controls how companies function
Recommended publications
  • Chapter 11. Fire Alarms and Democratic Accountability Charles M. Cameron and Sanford C. Gordon
    Chapter 11. Fire Alarms and Democratic Accountability Charles M. Cameron and Sanford C. Gordon 1 Introduction Accountability is a situation that prevails in any relationship between a principal and agent in which the latter takes some action for which she may be \held to account" { that is, made to answer for those actions under a system of rewards and sanctions administered by the former. In a democratic setting, the electorate are the principals and public officials the agents; rewards and sanctions the loss or retention of the benefits, privileges, and powers of office-holding. Absent electoral accountability, citizens must fall back on the benevolence of their rulers or just plain luck. History shows these are weak reeds indeed. Thus, the accountability (or unaccountability) of elected officials to voters is a key component of any comprehensive theory of democratic governance. Electoral accountability faces huge obstacles in practice. One of the most pernicious is the problem of asymmetric information: while knowing what politicians are up to is surely a critical ingredient of holding incumbent officeholders to account, for most voters, becoming and remaining informed about whether elected officials are actually meeting their obligations can be tedious, time- consuming and difficult. How many citizens have the leisure to research the voting record of their member of Congress, for instance? And even then, outside of a few specific areas, how many have the knowledge to assess whether a given legislative enactment actually improved their welfare, all things considered? A lack of transparency about actions and the obscurity between means and ends can render nominal accountability completely moot in practice.1 In the face of prohibitive information costs, a simple intuition is the following: any mechanism that lowers informational costs for voters ought to enhance electoral accountability.
    [Show full text]
  • Why AWS for Gxp Regulated Workloads? an Executive Summary
    Why AWS for GxP regulated workloads? An executive summary Move, or build, GxP workloads in the cloud with help from the AWS Life Sciences Practice The AWS life sciences practice and dedicated GxP experts help biopharma and medical device companies build new, or move, regulated workloads to the cloud. Organizations can achieve higher productivity, increased operational resilience, greater agility, improved transparency and traceability, and a lower TCO1 and carbon footprint on AWS2 compared to on-premises systems. AWS offers a secure cloud platform for automating compliance processes and providing enhanced management related to running your GxP workloads. Some of the biggest enterprises and innovative startups in life sciences have moved, or built new GxP systems on the AWS Cloud. Decades of expertise in the life sciences space enable us to help you move away from on-premises regulatory paradigms as your trusted advisor to becoming regulated cloud native. Evidence of success: Evidence of success: AWS customers AWS partners Moderna power their R&D and manufacturing Aizon use AWS to enable real-time visibility and environments on AWS to accelerate the development predictive insights that address GxP compliance. of mRNA therapeutics and vaccines. Idorsia house 90% of IT operations on AWS, including Core Informatics developed a platform on AWS that GxP compliant virtual data centers, giving them 75% enables GxP-validated applications in the cloud for cost savings compared to physical data centers its customers. Bristol Myers Squibb use AWS to create consistent, Tracelink choose AWS to support its life science scalable, and repeatable process to streamline cloud solution to meet customer compliance needs.
    [Show full text]
  • Suggestions from Social Accountability International
    Suggestions from Social Accountability International (SAI) on the work agenda of the UN Working Group on Human Rights and Transnational Corporations and Other Business Enterprises Social Accountability International (SAI) is a non-governmental, international, multi-stakeholder organization dedicated to improving workplaces and communities by developing and implementing socially responsible standards. SAI recognizes the value of the UN Working Group’s mandate to promote respect for human rights by business of all sizes, as the implementation of core labour standards in company supply chains is central to SAI’s own work. SAI notes that the UN Working Group emphasizes in its invitation for proposals from relevant actors and stakeholders, the importance it places not only on promoting the Guiding Principles but also and especially on their effective implementation….resulting in improved outcomes . SAI would support this as key and, therefore, has teamed up with the Netherlands-based ICCO (Interchurch Organization for Development) to produce a Handbook on How To Respect Human Rights in the International Supply Chain to assist leading companies in the practical implementation of the Ruggie recommendations. SAI will also be offering classes and training to support use of the Handbook. SAI will target the Handbook not just at companies based in Western economies but also at those in emerging countries such as Brazil and India that have a growing influence on the world’s economy and whose burgeoning base of small and medium companies are moving forward in both readiness, capacity and interest in managing their impact on human rights. SAI has long term relationships working with businesses in India and Brazil, where national companies have earned SA8000 certification and where training has been provided on implementing human rights at work to numerous businesses of all sizes.
    [Show full text]
  • From Corporate Responsibility to Corporate Accountability
    Hastings Business Law Journal Volume 16 Number 1 Winter 2020 Article 3 Winter 2020 From Corporate Responsibility to Corporate Accountability Min Yan Daoning Zhang Follow this and additional works at: https://repository.uchastings.edu/hastings_business_law_journal Part of the Business Organizations Law Commons Recommended Citation Min Yan and Daoning Zhang, From Corporate Responsibility to Corporate Accountability, 16 Hastings Bus. L.J. 43 (2020). Available at: https://repository.uchastings.edu/hastings_business_law_journal/vol16/iss1/3 This Article is brought to you for free and open access by the Law Journals at UC Hastings Scholarship Repository. It has been accepted for inclusion in Hastings Business Law Journal by an authorized editor of UC Hastings Scholarship Repository. For more information, please contact [email protected]. 2 - YAN _ZHANG - V9 - KC - 10.27.19.DOCX (DO NOT DELETE) 11/15/2019 11:11 AM From Corporate Responsibility to Corporate Accountability Min Yan* and Daoning Zhang** I. INTRODUCTION The concept of corporate responsibility or corporate social responsibility (“CSR”) keeps evolving since it appeared. The emphasis was first placed on business people’s social conscience rather than on the company itself, which was well reflected by Howard Bowen’s landmark book, Social Responsibilities of the Businessman.1 Then CSR was defined as responsibilities to society, which extends beyond economic and legal obligations by corporations.2 Since then, corporate responsibility is thought to begin where the law ends. 3 In other words, the concept of social responsibility largely excludes legal obedience from the concept of social responsibility. An analysis of 37 of the most used definitions of CSR also shows “voluntary” as one of the most common dimensions.4 Put differently, corporate responsibility reflects the belief that corporations have duties beyond generating profits for their shareholders.
    [Show full text]
  • Institutions, Organizations and Individuals Advocating for Corporate Accountability Condemn Chevron's Retaliatory Attacks on H
    Institutions, Organizations and Individuals Advocating for Corporate Accountability Condemn Chevron’s Retaliatory Attacks on Human Rights and Corporate Accountability Advocates and See it as a Serious Threat to Open Society and Due Process of Law January 23, 2014 - We, the undersigned organizations and individuals, condemn the actions by Chevron in its efforts to silence critics and ignore a $9.5 billion judgment against it for environmental damage in the Ecuadorian Amazon. Chevron’s actions set a dangerous precedent and represent a growing and serious threat to the ability of civil society to hold corporations accountable for their misdeeds around the world. Since Chevron launched its attack on those who have been working for decades to pressure the company to clean up the environmental damage caused by its operations in the Ecuadorian Amazon, independent journalists have been forced to turn over their material and nonprofit watchdog groups have faced massive legal actions designed to cripple their ability to work and undermine their ability to grow support for their efforts. Attacks Free Speech In a move opposed by The New York Times, ABC, CBS, NBC, Dow Jones, the Associated Press, the Hearst Newspapers, the Daily News, and the Gannett Company, Chevron used its legal might to launch a major threat to independent journalism when it won a decision to force documentary producer and director Joe Berlinger to turn over to Chevron more than 600 hours of raw footage. Chevron has also targeted nonprofit environmental and indigenous rights groups and individual activists with subpoenas designed to cripple their effectiveness and chill their speech.
    [Show full text]
  • What Is Corporate Accountability?
    WHAT IS CORPORATE ACCOUNTABILITY? BACKGROUND AND OVERVIEW Since the 1990s, the world has witnessed the growing importance and visibility of a range of initiatives led by businesses, social organisations and governments, with the stated aim of pressuring companies to behave in more socially responsible and accountable ways. This is a new development for many parts of the business world. Previously, the state (or government) was assumed to lead standard setting and behavioural norms for businesses in relation to most categories of stakeholders. When community organisations and interest groups wanted to change business behaviour, they focussed on changing the law. From the 1990s the focus changed, reflected in the emergence of new alliances and regimes of influence over business norms, linking together consumers, communities, workers and producers. What is the difference between corporate social responsibility (CSR) and corporate accountability? Corporate responsibility, corporate social responsibility (CSR) and corporate accountability are sometimes confused or seen to be synonymous. However, corporate responsibility and corporate accountability are typically distinguished from one another along several lines. Corporate responsibility in its broadest sense refers to varied practices that reflect the belief that corporations have responsibilities beyond generating profit for their shareholders. Such responsibilities include the negative duty to refrain from harm caused to the environment, individuals or communities, and sometimes also positive duties to protect society and the environment, for example protecting human rights of workers and communities affected by business activities. Such responsibilities are generally considered to extend not only to direct social and environmental impacts of business activity, but also to more indirect effects resulting from relationships with business partners, such as those involved in global production chains.
    [Show full text]
  • Columbia Tech Completes Successful ISO Reassessment Audit
    Columbia Tech Completes Successful ISO Reassessment Audit May 01, 2014 10:16 AM Eastern Daylight Time WORCESTER, MA -- Coghlin Companies announced today that Columbia Tech, a wholly-owned subsidiary specializing in manufacturing and global fulfillment services, has completed a successful ISO reassessment audit. Over a period of three days, a team of independent auditors from Intertek conducted an in-depth analysis and verified that Columbia Tech is adhering to all internal documented procedures and is fully compliant with ISO 9001:2008 and ISO 13485:2003. The auditors stated that Columbia Tech has an excellent Quality Management System and indicated how impressed they were with Columbia Tech’s management team, staff of caring associates, and their well-organized new manufacturing facility in Westborough, MA. Eric Skoglund, Columbia Tech’s Quality Control Manager and Management Representative, said, “It has long been recognized that ISO standards lead to improved quality and, as a direct result, enhance overall customer satisfaction time after time. Our current and future customers will continue to experience the benefits of collaborating with a partner that is completely dedicated to providing the highest quality products and services and an exceptional customer experience.” ISO 9001 is an international quality standard developed by the International Organization for Standardization (ISO) based on Quality Management Principles, including mutually beneficial supplier relationships, continuous improvement, and a customer-centric focus. These principles are incorporated within the requirements of the standard to improve organizational performance. ISO 13485 meets domestic and international regulations for medical device manufacturing, while achieving overall business improvement. About Columbia Tech Columbia Tech provides Time to Market Services at WARP SPEED™, including engineering design, manufacturing, global fulfillment and aftermarket services.
    [Show full text]
  • Data Integrity for Computerized Systems in Gxp Regulated Applications
    White Paper www.vaisala.com Managing GxP environmental systems to ensure data integrity In this paper, we provide an overview of data management best practices for life science systems and an overview of regulatory expectations. We offer eight recommendations for establishing and maintaining good practices for data integrity. More than Bytes management, companies can find Thanks to the publication of and Signatures changes hard to implement in terms enforcement actions such as GMP of updating systems and behavior. non-compliance reports, warning As efforts to ensure the quality and letters, import alerts, and notices, safety of drugs increase, so does it is evident that regulators are the amount of data generated by Data integrity: targeting data integrity failures those efforts. Over the last few Related regulations during inspections. Subsequent years, global regulatory scrutiny has turned to providing guidance Data integrity requirements are enforcement actions have led to on preserving the integrity of data. core elements of basic GMPs, and the withdrawal of supply across Throughout life science industries are broadly addressed in the FDA’s multiple markets, product recalls, — pharmaceutical, medical devices, Title 21 CFR Part 11 and the EU's consent decrees, and reputational and biotechnology research and GMP Eudralex Volume 4, Chapter damage for the firms involved. production — regulatory guidance 4 and Annex 11. However, with With increased targeting of and enforcement strategies are data integrity from regulators, being re-evaluated with a focus increasing automation based on it is now crucial that everyone on data integrity. With increasing computerized systems, as well as involved in GxP-regulated awareness of data collection and the globalization of operations storage, there comes increased and the increasing cost of bringing activities understand correct data awareness of gaps between products to market, new guidance management practices.
    [Show full text]
  • Article 6E. Iran Divestment Act. § 147-86.55. Article Title. This Article May Be Cited As the "Iran Divestment Act of 2015
    Article 6E. Iran Divestment Act. § 147-86.55. Article title. This Article may be cited as the "Iran Divestment Act of 2015. (2015-118, s. 1.) § 147-86.56. Findings. The General Assembly finds that: (1) Congress and the President have determined that the illicit nuclear activities of the Government of Iran, combined with its development of unconventional weapons and ballistic missiles and its support of international terrorism, represent a serious threat to the security of the United States, Israel, and other United States allies in Europe, the Middle East, and around the world. (2) The International Atomic Energy Agency has repeatedly called attention to Iran's unlawful nuclear activities, and, as a result, the United Nations Security Council has adopted a range of sanctions designed to encourage the Government of Iran to cease those activities and comply with its obligations under the Treaty on the Non-Proliferation of Nuclear Weapons. (3) On July 1, 2010, President Barack Obama signed into law H.R. 2194, the "Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010" (Public Law 111-195), which expressly authorizes states and local governments to prevent investment in, including prohibiting entry into or renewing contracts with, companies operating in Iran's energy sector with investments that have the result of directly or indirectly supporting the efforts of the Government of Iran to achieve nuclear weapons capability. (4) The serious and urgent nature of the threat from Iran demands that states, local governments, and private institutions work together with the federal government and American allies to do everything possible diplomatically, politically, and economically to prevent Iran from acquiring nuclear weapons capability.
    [Show full text]
  • Corporate Social Responsibility: Who's Responsible?
    Corporate Social Responsibility: Who's Responsible? Finding an Organizational Home for an Increasingly Critical Function First Author: Julia Bonner M.S., New York University Second Author: Adam Friedman Professor, New York University Principal, Adam Friedman Associates LLC 1 Abstract Corporate social responsibility (CSR) is still a relatively new corporate function that continues to change and evolve. Research has not yet fully explored how CSR-related decisions are made within large companies and what departments have the most impact on CSR strategies. Using both quantitative and qualitative methods, this study examines how executives within Fortune 1000 organizations develop, measure and report the results of one particular aspect of their CSR initiatives. Results show that while the views and philosophies of the C-suite and board of directors are highly influential, other units and departments in the company are involved in the CSR process. The input of other company departments, notably the sales and marketing departments, indicate a linkage between CSR and profitability. Results also suggest the future of CSR as a corporate function may disappear as organizations begin to absorb its principles into the fabric of their respective businesses. Highlights Support from top management and the CEO is crucial in driving CSR communication and implementing the company’s CSR programs. Increasingly, many Fortune 1000 companies are using social media as part of the methodologies to assess their reputations and measure their CSR programs. External stakeholders are an important audience in the measurement process. The C-suite and board of directors are important influencers in setting CSR policies, but other departments are involved in the CSR process.
    [Show full text]
  • Module on Social Accountability and Social
    MODULE ON SOCIAL ACCOUNTABILITY AND SOCIAL AUDIT Introduction to Social Accounting An organization is a social unit as its activities vitally effect the society and its members. It uses the society resources and produces goods and services for which the society is the ultimate consumer. The society also provides the infrastructure and facilities without which organization cannot function at all. Thus an organization owes its very existence and survival to the society. Therefore, it is necessary that each organization must discharge social responsibility. Further, organizations are an important instrument of social change. They have been helping the society through quality equipment, investment in development of its people and reliable service to public at large. Now-a-days, it is being realized that commercial evaluation of infrastructure development projects is not enough to justify commitment of funds to a project, specially when it belongs to the public sector. The social aspect must not be ignored as the projects in public sector concerning either with the development of infrastructure facilities or otherwise necessary in the general goods of the society. Their evaluation should be done keeping in view the social costs and benefits associated with them. In view of the above, there is a growing demand for reports and activities which reflect the contribution of an enterprise to the society. It is being argued that accounting must deal with measurement and communication of performance of an enterprise in relation to its social responsibilities. Consequently, corporate accounting and reporting system, which hitherto focused their attention on proprietor and management, now, are called upon to shift their focus to the pluralistic concept of corporate social accountability.
    [Show full text]
  • Oracle Managed Compliance Services Help Customers Define and Manage Their Cloud Platforms and Processes According to Industry Standards Or Legislative Regulations
    Oracle Managed Compliance Services help customers define and manage their cloud platforms and processes according to industry standards or legislative regulations. This includes Payment Card Industry-Data Security Standards (PCI-DSS), Health Insurance Portability and Accountability Act of 1996 (HIPAA), and GxP validation. Oracle Managed Compliance Services packages include design, implementation, monitoring, ongoing management, and reporting. ENABLING COMPLIANCE WITH INDUSTRY AND REGULATORY STANDARDS Key Features Systems monitoring, alerts, and Compliance with industry and regulatory standards is mandatory for many enterprises, especially access control financial services and healthcare industries. Required standards in data security, integrity, and privacy can be challenging to achieve and maintain in cloud deployments. Mandatory audits and Frequent vulnerability assessments reporting call for a high level of expertise and can bind significant resources of enterprise security teams throughout the year. Proactive risk detection and improvement recommendations APPLICABLE REGULATIONS External and internal vulnerability scans Payment Card Compliance with the PCI-DSS is an international requirement by the payment Installation and management of Industry (PCI) card industry for enterprises and government agencies that store, process, or applicable Oracle security transmit credit card information. software Health Insurance HIPAA is a legislative requirement in the United States, which aims at health Complete and accurate reporting and
    [Show full text]