DOCSLIB.ORG

Data Integrity for Computerized Systems in Gxp Regulated Applications

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read 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. industry practice and existing was needed to clarify regulatory technology. Although there are expectations around the creation, new strategies available for data handling, and storage of data. Principles and Practice The acronym ALCOA is used by the FDA, MHRA, the World Health Organization and others to outline expectations on records, including In essence, data integrity means paper-based, electronic, and hybrid records (systems that use both paper that data collected and stored and electronic records). ALCOA is a useful guide to remembering key must be original, complete and points of data management for GxP compliance. ALCOA stands for: traceable. Several regulatory agencies have defined the term “data integrity.” In the UK, the Medicines and Healthcare A = Attributable to the person generating the data products Regulatory Agency = Legible and permanent (MHRA) defined data integrity L in their 2015 document: “MHRA C = Contemporaneously recorded GMP Data Integrity Definitions O = Original or a true copy and Guidance for Industry” as the degree to which all collected A = Accurate data are “complete, consistent, accurate, trustworthy, reliable… throughout the data lifecycle.” The WHO added some extra definitions to ALCOA in their working document “Guideline on data integrity” expanding the acronym to For their 2016 draft guidance ALCOA+. In addition to original emphasis of ALCOA principles, the “+” for industry “Data Integrity and highlights the importance of the attributes of being complete, consistent, Compliance with CGMP” the enduring and available.* FDA defines data integrity as: “… the completeness, consistency, Thus, ALCOA+ is now the goal for every piece of GMP information – and accuracy of data. Complete, information that can impact the purity, efficacy, and safety of products. consistent, and accurate data ALCOA+ is the standard by which data integrity is evaluated. In practice, should be attributable, legible, this means that companies must maintain control over all intentional and contemporaneously recorded, unintentional changes to GMP data, including the prevention of data loss original or a true copy, and or corruption. accurate (ALCOA).” Data Management A review of enforcement actions ▪ Electronic data could have been Challenges proves that many companies manipulated or deleted without are misinterpreting guidance traceability. Regardless of the methods used to documents. Other industry gather and store data — manual, stakeholders try to help with ▪ Raw data were copied to a CD automatic, or a combination — more explicative documents. For and then deleted from the hard there are always opportunities for example, the European Compliance drive. Data copied were selected failure. Manual processes entail Academy (ECA) published an manually without assurance that obvious points of possible failure: article specifying data integrity all raw data was copied before operators can forget to record failures that caused one company being permanently deleted. information, record incorrect to receive an FDA Warning Letter. values, lose records, or even Observations included: Each of these deviations could intentionally falsify data. The risks have been addressed by systems Failure to exercise sufficient associated with computerized ▪ and methods including: controls over computerized systems are more technical. For systems to prevent unauthorized Unique usernames and passwords both manual and automated ▪ access or changes to data, and methods, regulatory agencies ▪ A durable and inerasable audit to provide controls to prevent have described the regulatory trail or event log omission of data. expectations in their guidelines ▪ Separate administrator and user and draft documents. ▪ The computerized system access rights lacked access controls and audit trail capabilities. ▪ Good standard operating * See also: WHO Technical Report procedures (SOPs) 996, Annex 5, “Guidance on good ▪ All employees had administrator data and record management rights and shared one user name. ▪ Oversight and regular review of practices” processes Key areas of data integrity control There are seven functional areas consistently mentioned in regulations and guidance on data integrity. Here we review these key areas, focusing on how they apply to environmental monitoring applications. Quality Risk Management1 Personnel2 Documentation ▪ Understand the potential ▪ Document and communicate ▪ Implement and require Good impact of all data on product roles and responsibilities. Documentation Practice quality and patient safety. (GDocP) in all written ▪ Provide technical support for documents and SOPs. ▪ Understand the basic systems administration. technologies used in your Follow relevant regulations data processes, and their Assign responsibility for data ▪ ▪ when creating and reviewing inherent limitations. throughout its entire lifecycle. documents. For example, ▪ Implement systems that ▪ Encourage a workplace culture CFR Title 21, Part 211 “Current provide an acceptable state that supports issue reporting. Good Manufacturing Practice of control that is matched for Finished Pharmaceuticals” to risks and criticality of the ▪ Implement systems that Subpart J - Records & Reports. process in question. can identify and minimize potential risks. ▪ Identify and document points of risk for unauthorized ▪ Create behavioral controls for or untraceable deletion personnel, procedural controls Data Life Cycle or amendment, as well as for processes, and technical opportunities for detection controls for technologies. ▪ Implement change through routine reviews. management and control of Analyze the root causes of Schedule and perform periodic ▪ incidents and deviations. ▪ compliance failures in order to risk assessments as technology fix them systemically. and processes change. ▪ Ensure corrective and preventive action (CAPA) Provide technology training to Authorize appropriate access ▪ ▪ processes and procedures. ensure existing technologies privileges for each system. are used to their full potential. Training Vendors/Providers Audits & Internal Inspections3 ▪ Provide regular training, and ▪ Ensure providers have qualified ▪ Create detailed review document training completion and trained personnel. processes for inspection including personnel identities findings, non-compliance and dates. ▪ Review providers’ quality management systems. reports, and Warning Letters. ▪ Ensure training is matched ▪ Perform routine in-house data to different roles involved ▪ Note compliance to standards audits, including: audit trails, with data - including quality such as ISO 9001, or ISO 17025. raw data and metadata, and assurance, quality control, ▪ Perform regular checks original records. production and management of providers’ systems ▪ Schedule regular review of - with an emphasis on Good and services; audit where system user access rights. Documentation Practices. necessary and/or allowable. Report audit results to senior ▪ Store training documentation ▪ Review contracts, technical ▪ where it is easily retrievable by management and other agreements, and quality those involved with regulatory relevant stakeholders. agreements. and 3rd party inspections. 1 A key document in this area 2 Personnel management directs 3 If a hybrid system is in use is ICH Q9. This guideline from and controls how companies (both paper and electronic data the ICH Expert Working Group function to achieve business goals. are generated), the original data provides a methodology for Focusing on personnel ensures should also be checked routinely a risk-based
Load more

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]
  • Supply Chain Operations Audit
    Building 243 University Campus Cranfield Bedford MK43 0AL Tel: +44 (0)1234 750323 Fax: +44 (0)1234 752040 www.scp-uk.co.uk Supply Chain Operations Audit by Dr. David Lascelles, Supply Chain Planning UK Limited High Impact Supply Chains Supply chain excellence has a real impact on business strategy. Supply chain management is a high impact mission that goes to the roots of a company’s very competitiveness. High-impact supply chains win market share and customer loyalty, create shareholder value, extend the strategic capability and reach of the business. Independent research shows that excellent supply chain management can yield: · 25-50% reduction in total supply chain costs · 25-60% reduction in inventory holding · 25-80% increase in forecast accuracy · 30-50% improvement in order-fulfilment cycle time · 20% increase in after-tax free cash flows That’s what we mean by high-impact. Does a high-impact supply chain leverage your business enterprise? Five Critical Success Factors Building a high-impact supply chain represents one of the most exciting opportunities to create value – and one of the most challenging. The key to success lies in knowing which levers to pull. Our research, together with practical experience, reveals that high-impact supply chains are, essentially, a function of five critical success factors: 1. A clear strategy: for the entire supply chain, tuned to market opportunities and focussed on customer service needs. 2. An integrated organisation structure: enabling the supply chain to operate as a single synchronised entity. 3. Excellent processes: for implementing the strategy, embracing all plan- source-make-deliver operations.
    [Show full text]
  • SA 8000:2014 Documents with Manual, Procedures, Audit Checklist
    D127: Demo of SA8000:2014 Documentation Kit Price 450 USD Total editable documentation package Complete editable document tool kit (Social manual, procedures, social policy, Social Committee, formats, SOPs, SA 8000 audit checklist etc.) ALL documents helps for certification to SA 8000-2014 Buy: www.Documentationconsultancy.com Chapter-1.0 CONTENTS OF SOCIAL ACCOUNTABILITY DOCUMENT KIT (More than 95 Editable document files in word/excel) A. The Total Editable Document kit has 8 main directories as below in Ms. word. D 127 – SA8000-2014 Document kit Sr. List of Directory Document of Details No. 1. Social Manual 07 files – 22 pages in Ms. word 2A. Procedures – Systems 08 procedures – 29 pages in Ms. word 2B. Procedures – OHS 09 procedures – 18 pages in Ms. word 3. Social Policy (English) 08 policies – 10 pages in Ms. word 4. Social Committee 08 files – 12 pages in Ms. word Formats / Templates 43 formats – approx. 50 pages in Ms. Name of departments Word OHS 17 formats in Ms. Word 5. Purchase (PUR) 05 formats in Ms. Word System and social accountability (SYS) 17 formats in Ms. Word Administration and Training (TRG) 05 formats in Ms. Word Standard Operating Procedures 6. 10 SOPs – 15 pages in Ms. word (SOPs) 7. Audit Checklist 03 files of more than 150 audit questions Total 96 files quick download in editable form by e delivery For more détails about SA8000:2014 Documentation Kit Features and Uses Click Here E-mail: [email protected] Tele: +91-79-2979 5322 Page 1 of 10 D127: Demo of SA8000:2014 Documentation Kit Price 450 USD Total editable documentation package Complete editable document tool kit (Social manual, procedures, social policy, Social Committee, formats, SOPs, SA 8000 audit checklist etc.) ALL documents helps for certification to SA 8000-2014 Buy: www.Documentationconsultancy.com Part: B.
    [Show full text]
  • Guide to Inspections of Quality Systems
    FOOD AND DRUG ADMINISTRATION GUIDE TO INSPECTIONS OF QUALITY SYSTEMS 1 August 19991 2 Guide to Inspections of Quality Systems This document was developed by the Quality System Inspec- tions Reengineering Team Members Office of Regulatory Affairs Rob Ruff Georgia Layloff Denise Dion Norm Wong Center for Devices and Radiological Health Tim Wells – Team Leader Chris Nelson Cory Tylka Advisors Chet Reynolds Kim Trautman Allen Wynn Designed and Produced by Malaka C. Desroches 3 Foreword This document provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer’s compliance with the Quality System Regulation and related regulations. The new inspectional process is known as the “Quality System Inspection Technique” or “QSIT”. Field investigators may conduct an ef- ficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm’s quality system. Note: This manual is reference material for investi- gators and other FDA personnel. The document does not bind FDA and does not confer any rights, privi- leges, benefits or immunities4 for or on any person(s). Table of Contents Performing Subsystem Inspections. 7 Pre-announced Inspections. ..13 Getting Started. .15 Management Controls. .17 Inspectional Objectives 18 Decision Flow Chart 19 Narrative 20 Design Controls. .31 Inspectional Objectives 32 Decision Flow Chart 33 Narrative 34 Corrective and Preventive Actions (CAPA). .47 Inspectional Objectives 48 Decision Flow Chart 49 Narrative 50 Medical Device Reporting 61 Inspectional Objectives 62 Decision Flow Chart 63 Narrative 64 Corrections & Removals 67 Inspectional Objectives 68 Decision Flow Chart 69 Narrative 70 Medical Device Tracking 73 Inspectional Objectives 74 Decision Flow Chart 75 Narrative 76 Production and Process Controls (P&PC).
    [Show full text]
  • Social Accounting: a Practical Guide for Small-Scale Community Organisations
    Social Accounting: A Practical Guide for Small-Scale Community Organisations Social Accounting: A Practical Guide for Small Community Organisations and Enterprises Jenny Cameron Carly Gardner Jessica Veenhuyzen Centre for Urban and Regional Studies, The University of Newcastle, Australia. Version 2, July 2010 This page is intentionally blank for double-sided printing. Table of Contents INTRODUCTION……………………………………………………………………..1 How this Guide Came About……………………………………………………2 WHAT IS SOCIAL ACCOUNTING?………………………………………………..3 Benefits.………………………………………………………………………....3 Challenges.……………………………………………………………………....4 THE STEPS………………………………………...…………………………………..5 Step 1: Scoping………………………………….………………………………6 Step 2: Accounting………………………………………………………………7 Step 3: Reporting and Responding…………………….……………………….14 APPLICATION I: THE BEANSTALK ORGANIC FOOD…………………….…16 APPLICATION II: FIG TREE COMMUNITY GARDEN…………………….…24 REFERENCES AND RESOURCES…………………………………...……………33 Acknowledgements We would like to thank The Beanstalk Organic Food and Fig Tree Community Garden for being such willing participants in this project. We particularly acknowledge the invaluable contribution of Rhyall Gordon and Katrina Hartwig from Beanstalk, and Craig Manhood and Bill Roberston from Fig Tree. Thanks also to Jo Barraket from the The Australian Centre of Philanthropy and Nonprofit Studies, Queensland University of Technology, and Gianni Zappalà and Lisa Waldron from the Westpac Foundation for their encouragement and for providing an opportunity for Jenny and Rhyall to present a draft version at the joint QUT and Westpac Foundation Social Evaluation Workshop in June 2010. Thanks to the participants for their feedback. Finally, thanks to John Pearce for introducing us to Social Accounting and Audit, and for providing encouragement and feedback on a draft version. While we have adopted the framework and approach to suit the context of small and primarily volunteer-based community organisations and enterprises, we hope that we have remained true to the intentions of Social Accounting and Audit.
    [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]
  • Chemical Management Audit Certification Supplier Management Verification Solutions
    CHEMICAL MANAGEMENT AUDIT CERTIFICATION SUPPLIER MANAGEMENT VERIFICATION SOLUTIONS Intertek’s Chemical Management Audit solution is designed to help retailers and brands verify the safe handling and proper disposal of chemicals, in order to promote chemical management best practices throughout the global supply chain network. Your challenges, our solutions • Improved chemical management system unique techniques to best drive improvement Intertek’s Chemical Management Audit and practice through reduced environmental footprint, solution can help ensure effective chemical • Benchmarked results with global visibility increased efficiency and cost savings. management across your supply chain. The • Management transparency to enable This Chemical Management Audit is offered as process starts with an application of chemical targeted efforts. part of Intertek’s Supply Chain Solutions which expertise to provide a facility baseline risk help organizations all over the world manage • Identification of process efficiency and cost indicator, from which auditing of your facility compliance, risk, sustainability, and quality in savings can be efficiently planned. the supply chain. Intertek’s web-based platform and software • Assistance with green product design and helps ensure our Chemical Management certification Audit approach is the ideal tool for • Protect reputation risk, people and evaluating, tracking and monitoring chemical environment management performance in factories, Upon satisfactory completion of the chemical FOR MORE INFORMATION ultimately assuring overall performance management assessment and performance improvements. criteria, the manufacturer will receive a Intertek’s Chemical Management Audit report which details performance as well UK +44 116 296 1620 solution includes modular guidance for: as benchmarked comparisons with peers. The report showcases commitments of • Chemical Supply & Policy AMER +1 800 810 1195 moving towards zero discharge of hazardous • Management Practices chemicals.
    [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]
  • Conflict of Interest Program Audit December 6, 2019
    City of Edmonton Office of the City Auditor Conflict of Interest Program Audit December 6, 2019 1200, Scotia Place, Tower 1 10060 Jasper Avenue Edmonton, AB T5J 3R8 Phone: 780-496-8300 edmonton.ca/auditor REPORT SUMMARY Conflict of Interest Program Audit 2019 Governance Framework The definition, principles, and roles and Recommendation: Update the responsibilities in the Code of Conduct related to corporate conflict of interest conflicts of interest need to be enhanced to provide governance framework. additional processes and accountabilities to ensure conflicts of interests are understood, prevented, detected, and remediated appropriately. Guiding Documents Recommendation: Develop Conflict of interest guidance is embedded in clear guiding documents the Code of Conduct guiding documents. These specific to conflict of interest documents do not provide clear guidance on that are tailored to the City’s how to manage the conflict of interest risks to needs and risks. which the City is vulnerable. Training and Communication Recommendations: Conflict of interest training is included in • Ensure all employees have Code of Conduct training. Current records completed the Code of Conduct show that 67% of City of Edmonton training upon hiring. employees have completed mandatory • Provide on-going conflict of Code of Conduct training. Conflict of interest communication, and interest information and tools are difficult accessible information and tools. to find. 1 Report Highlights Background ..........................................................................
    [Show full text]
  • Practical Risk-Based Guide for Managing Data Integrity
    1 ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE Practical risk-based guide for managing data integrity Version 1, March 2019 2 PREAMBLE This original version of this guidance document has been compiled by a subdivision of the APIC Data Integrity Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC. The Task Force members are: Charles Gibbons, AbbVie, Ireland Danny De Scheemaecker, Janssen Pharmaceutica NV Rob De Proost, Janssen Pharmaceutica NV Dieter Vanderlinden, S.A. Ajinomoto Omnichem N.V. André van der Biezen, Aspen Oss B.V. Sebastian Fuchs, Tereos Daniel Davies, Lonza AG Fraser Strachan, DSM Bjorn Van Krevelen, Janssen Pharmaceutica NV Alessandro Fava, F.I.S. (Fabbrica Italiana Sintetici) SpA Alexandra Silva, Hovione FarmaCiencia SA Nicola Martone, DSM Sinochem Pharmaceuticals Ulrich-Andreas Opitz, Merck KGaA Dominique Rasewsky, Merck KGaA With support and review from: Pieter van der Hoeven, APIC, Belgium Francois Vandeweyer, Janssen Pharmaceutica NV Annick Bonneure, APIC, Belgium The APIC Quality Working Group 3 1 Contents 1. General Section .............................................................................................................................. 4 1.1 Introduction ............................................................................................................................ 4 1.2 Objectives and Scope .............................................................................................................. 5 1.3 Definitions and abbreviations ................................................................................................
    [Show full text]