{"id":5633,"date":"2025-01-10T15:57:58","date_gmt":"2025-01-10T06:57:58","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=5633"},"modified":"2025-01-14T09:05:49","modified_gmt":"2025-01-14T00:05:49","slug":"data_integrity","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/","title":{"rendered":"Data Integrity (DI) Consulting"},"content":{"rendered":"<div id=\"contamination_control_strategy\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/\">Home<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\">Services<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\">Consulting<\/a>\/<\/li>\n<li>Data Integrity (DI) Consulting<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Consulting<\/span><br class=\"wpTag\">Data Integrity (DI) Consulting<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n\t<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Consulting Data Integrity (DI) Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2025\/01\/data_integrity_KEYVISUAL___.jpg\" alt=\"Consulting Data Integrity (DI) Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2025\/01\/data_integrity_KEYVISUAL___.jpg\" alt=\"Consulting Data Integrity (DI) Consulting\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<section class=\"secBox\">\n<h2 class=\"headLine05\">What is Data Integrity?<\/h2>\n<p class=\"text01\">Data integrity refers to <span class=\"Bold\">the completeness, consistency, and accuracy of data<\/span>, and it is required to be ensured throughout the lifecycle of pharmaceuticals. To ensure data integrity, the principles of ALCOA+ are presented within various guidelines.<\/p>\n<div class=\"comExtractBox\">\n<h3 class=\"headLine10\">Principles of ALCOA+<\/h3>\n<ul class=\"comNumList\">\n<li><span class=\"num\">1.<\/span><span class=\"txt\">Attributable: Data can be attributed to who did what, when, and where.<\/span><\/li>\n<li><span class=\"num\">2.<\/span><span class=\"txt\">Legible: Data can be read by anyone.<\/span><\/li>\n<li><span class=\"num\">3.<\/span><span class=\"txt\">Contemporaneous: Data is recorded and created at the time it occurs.<\/span><\/li>\n<li><span class=\"num\">4.<\/span><span class=\"txt\">Original: Data is original or equivalent to the original.<\/span><\/li>\n<li><span class=\"num\">5.<\/span><span class=\"txt\">Accurate: Data is recorded and created accurately.<\/span><\/li>\n<li><span class=\"num\">6.<\/span><span class=\"txt\">Complete: All data exists, not just parts of it.<\/span><\/li>\n<li><span class=\"num\">7.<\/span><span class=\"txt\">Consistent: Data is consistent and without contradictions.<\/span><\/li>\n<li><span class=\"num\">8.<\/span><span class=\"txt\">Enduring: Data is protected long-term and exists throughout its lifecycle.<\/span><\/li>\n<li><span class=\"num\">9.<\/span><span class=\"txt\">Available: Data is accessible and available for use at any time.<\/span><\/li>\n<\/ul>\n<\/div>\n<div>&nbsp;<\/div>\n<p class=\"comTxt\">Ensuring data integrity is required for all data and records, regardless of whether they are on paper or in electronic form. It is an urgent issue in the pharmaceutical industry, as the reliability of data and records is directly linked to the reliability of the quality of the pharmaceuticals.<\/p>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Data Governance<\/h2>\n<p class=\"wpTag\">The establishment of data governance requires active involvement from senior management. Senior management is responsible for establishing the organization\u2019s quality culture, maintaining and continuously improving it, and building an effective data governance system. They are also responsible for creating a corporate culture that provides an appropriate working environment, where everything can be reported openly and transparently. A quality culture centered around senior management should be established, along with a data governance system that ensures data integrity throughout the lifecycle. <\/p>\n<p>Some specific policies and procedures for operating a data governance system include the following examples. (WHO Annex 4. Guideline on Data Integrity)\n<\/p>\n<div class=\"comExtractBox\">\n<h3 class=\"headLine10\">WHO Annex 4. Guideline on Data Integrity<\/h3>\n<ul class=\"comNumList\">\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">management oversight and commitment;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">the application of QRM;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">compliance with data protection legislation and best practices;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">qualification and validation policies and procedures;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">change, incident and deviation management;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">data classification, confidentiality and privacy;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">security, cybersecurity, access and configuration control;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">database build, data collection, data review, blinded data, randomization;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">the tracking, trending, reporting of data integrity anomalies, and lapses or failures for further action;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">the prevention of commercial, political, financial and other organizational pressures;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">adequate resources and systems;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">workload and facilities to facilitate the right environment that supports DI and effective controls;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">monitoring;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">record-keeping;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">training;<\/span><\/li>\n<li><span class=\"num\">\u25a0 <\/span><span class=\"txt\">awareness of the importance of data integrity, product quality and patient safety.<\/span><\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Examples of Observations in GMP Inspections Related to Data Integrity<\/h2>\n<p class=\"text01\">In recent years,  there is an increasing trend of observations related to data integrity in GMP inspections. Specific examples of such observations include:<\/p>\n<div class=\"comExtractBox\">\n<h3 class=\"headLine10\">Examples of Observations in GMP Inspections Related to Data Integrity<\/h3>\n<ul class=\"comNumList\">\n<li><span class=\"num\">1.<\/span><span class=\"txt\">Data could be deleted or modified by all users.<\/span><\/li>\n<li><span class=\"num\">2.<\/span><span class=\"txt\">There was no audit trail functionality for several pieces of testing equipment.<\/span><\/li>\n<li><span class=\"num\">3.<\/span><span class=\"txt\">Retesting of samples was conducted without a legitimate reason, and some test data was deleted.<\/span><\/li>\n<li><span class=\"num\">4.<\/span><span class=\"txt\">The head of the testing department had administrator access rights, creating a possibility of test result manipulation.<\/span><\/li>\n<li><span class=\"num\">5.<\/span><span class=\"txt\">Data backup was not being conducted.<\/span><\/li>\n<li><span class=\"num\">6.<\/span><span class=\"txt\">Blank formats were issued and managed by the manufacturing and testing departments, creating a possibility of record substitution, etc.<\/span><\/li>\n<\/ul>\n<\/div>\n<div>&nbsp;<\/div>\n<p class=\"wpTag\">For data management, attention should be paid to the following points for both paper-based and electronic records.<\/p>\n<div class=\"comStepInner\">\n<div class=\"area\">\n<h3 class=\"headLine06\">Examples of points to note <br class=\"sp\">for paper-based data management<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<ul class=\"comNumList\">\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Identification of individual operators<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Management of the locations where records are used<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Use of permanent ink and methods for corrections<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Management of blank forms\/templates<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Management methods for authentic copies<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Management of records printed out from electronic systems<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Versioning and issuance management<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Review and double-checking of records<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Filing, searching, storing, archiving, and discarding records<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Protection of records from disasters, etc.<\/span><\/li>\n<\/ul><\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/data_integrity_image01.jpg\" alt=\"Examples of points to note for paper-based data management\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div>&nbsp;<\/div>\n<div>&nbsp;<\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\">Examples of points to note <br class=\"sp\">for electronic data management<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<ul class=\"comNumList\">\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Audit trail functionality<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">System security<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Data management (raw data, metadata)<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Management of operational permissions (separation of system administrators and general users, etc.)<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Backup and archiving procedures<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Conducting CSV (Computer System Validation) at system implementation and periodic system verification<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">System updates<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Data transfer methods<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Management of dynamic electronic data<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Methods for data review<\/span><\/li>\n<\/ul><\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/data_integrity_image02.jpg\" alt=\"Examples of points to note for electronic data management\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<section class=\"secBox comBorBox\">\n<h2 class=\"headLine05\">CM Plus\u2019s <br class=\"wpTag\"><br \/>\n\tData Integrity Support Services<\/h2>\n<p class=\"text01\">CM Plus offers the following support services for customers facing challenges with data integrity compliance.<\/p>\n<div class=\"comStepInner\">\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">Service 1<\/span>Data Integrity Seminar<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">We provide clear explanations of key points and examples of observations related to data integrity compliance. We can also customize seminar plans according to the needs and concerns of our customers.<\/p>\n<\/p><\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/data_integrity_image03.jpg\" alt=\"Data Integrity Seminar\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div>&nbsp;<\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">Service 2<\/span>Data Integrity Consulting<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">We provide consulting on existing data governance systems to support our customers\u2019 data integrity compliance. Specifically, we offer services such as:<\/p>\n<ul class=\"comNumList\">\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Gap analysis and improvement proposals for existing data governance systems and QMS<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Conducting mock inspections in preparation for GMP surveys<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Gap analysis and improvement proposals for existing computer systems<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Consultation and support for addressing inspection observations<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">SOP review and creation support<\/span><\/li>\n<\/ul><\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/data_integrity_image04.jpg\" alt=\"Data Integrity Consulting\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div>&nbsp;<\/div>\n<div class=\"area\">\n<h3 class=\"headLine06\"><span class=\"sml\">Service 3<\/span>Data Integrity Compliance and CSV Support During Computer System Implementation<\/h3>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<p class=\"wpTag\">When implementing computer systems, it is necessary to consider the implementation of features that meet data integrity requirements and to conduct CSV. We offer the following support for your system implementation projects:<\/p>\n<ul class=\"comNumList\">\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Support for creating CSV-related documentation for new systems<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Support for creating URS, including data integrity requirements<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Support for creating risk assessments related to data integrity<\/span><\/li>\n<li><span class=\"num\">\u30fb<\/span><span class=\"txt\">Project management support for system implementation projects<\/span><\/li>\n<\/ul><\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/data_integrity_image05.jpg\" alt=\"Data Integrity Compliance and CSV Support During Computer System Implementation\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div>&nbsp;<\/div>\n<div><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/Dot_2.png\" width=\"3%\" height=\"\" alt=\"\"><\/div>\n<div><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/Dot_2.png\" width=\"3%\" height=\"\" alt=\"\"><\/div>\n<div><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/uploads\/2024\/09\/Dot_2.png\" width=\"3%\" height=\"\" alt=\"\"><\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/themes\/cmplus\/image\/common\/arrow06.webp\" alt=\"\"><\/div>\n<div class=\"area pink\">\n<div class=\"ttlBox\">\n<div class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/themes\/cmplus\/image\/common\/icon_img07.webp\" alt=\"Feel Free to Contact CM Plus\"><\/div>\n<h3 class=\"headLine06\">Feel Free to Contact CM Plus<\/h3>\n<\/p><\/div>\n<p class=\"wpTag\">CM Plus has consultants from various fields who can customize services to meet your needs. Feel free to contact us.<\/p>\n<div class=\"comApplyLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/contact_us\/\"><span class=\"sub\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/themes\/cmplus\/image\/common\/icon-mail.webp\" width=\"20\" alt=\"Click here to contact us.\">Click here to contact us.<\/span><\/a><\/div>\n<\/p><\/div>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Contents<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Useful Information<\/h2>\n<p class=\"wpTag\">Please refer to our information dissemination site \u201cGMP Platform\u201d for related articles.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/wp-content\/themes\/cmplus\/image\/common\/photo13.webp\" alt=\"New WHO Guidance on Data Integrity\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">New WHO Guidance on Data Integrity<\/h4>\n<p class=\"wpTag\">Data integrity issues, such as data falsification and fabrication, have become a global concern. The number of data integrity citations in FDA warning letters has been on the rise.<br \/>\n<br class=\"wpTag\"><br \/>\n\t\t\t\tWhile often translated as &#8220;data completeness,&#8221; data integrity is not as grand a concept as it may sound. It refers to the fundamental requirements that individuals and systems involved in data generation must adhere to in order to ensure data reproducibility, and it is a cornerstone of Good Manufacturing Practices (GMP). Although not a new GMP requirement, the increasing prevalence of data handling issues has led to the publication of data integrity guidelines by various international organizations. For example&#8230;<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=16469\" target=\"_blank\" rel=\"noopener noreferrer\">New WHO Guidance on Data Integrity<\/a><\/div>\n<\/div>\n<\/section>\n<section class=\"comOtherBox comOtherBox02\">\n<h2 class=\"headLine04\">Other Services<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo01.webp\" alt=\"Engineering, Project Management\"><\/span><br \/>\n<span class=\"subSpan\">Engineering, Project Management<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"Education\/Training Support\"><\/span><br \/>\n<span class=\"subSpan\">Education\/Training Support<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/div>\n<p><span class=\"subSpan\">Technical Information Services<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<\/article>\n<aside id=\"sideBar\">\r\n\t<p class=\"sideTtl\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\"><span class=\"txtSpan barlow\">Services<\/span><\/a><\/p>\r\n\t<ul id=\"menu-service\" class=\"sideList\"><li id=\"menu-item-238\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-238\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-253\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-253\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/production_facility\/\">One-Stop Service for Production Facilities<\/a><\/li>\n\t<li id=\"menu-item-240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-240\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/construction_management\/\">About Construction Management<\/a><\/li>\n\t<li id=\"menu-item-239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-239\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/feature\/\">Construction Management by CM Plus<\/a><\/li>\n\t<li id=\"menu-item-6143\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-6143\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_management_consultant\/\">Project Management Consultant (PMC)<\/a><\/li>\n\t<li id=\"menu-item-243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-243\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\">Facility Construction<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-245\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\">Business Concept<\/a><\/li>\n\t\t<li id=\"menu-item-246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-246\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\">Conceptual Design<\/a><\/li>\n\t\t<li id=\"menu-item-247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-247\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\">Basic Design<\/a><\/li>\n\t\t<li id=\"menu-item-248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-248\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\">Procurement<\/a><\/li>\n\t\t<li id=\"menu-item-249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-249\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\">Detailed Design \/ Production Management<\/a><\/li>\n\t\t<li id=\"menu-item-244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-244\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\">Trial Operation -Commissioning &#038; Qualification-<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-254\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-254\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/\">Sectors<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-242\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-242\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/\">Pharmaceuticals and Medical Devices<\/a>\n\t\t<ul class=\"sub-menu\">\n\t\t\t<li id=\"menu-item-263\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-263\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/sterile_medicine\/\">Sterile Pharmaceutical<\/a><\/li>\n\t\t\t<li id=\"menu-item-264\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-264\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/oral_agent\/\">Oral Drugs<\/a><\/li>\n\t\t\t<li id=\"menu-item-256\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-256\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/medium_molecule_drugs\/\">Medium-Molecule API<\/a><\/li>\n\t\t\t<li id=\"menu-item-257\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-257\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/macromolecular_drugs\/\">Large-Molecule (Biopharmaceutical) API<\/a><\/li>\n\t\t\t<li id=\"menu-item-813\" class=\"menu-item menu-item-type-custom menu-item-object-custom menu-item-813\"><a href=\"\/en\/service\/consulting\/regenerative_medicine\/\">Regenerative Medicine<\/a><\/li>\n\t\t<\/ul>\n<\/li>\n\t\t<li id=\"menu-item-265\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-265\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/food\/\">Food<\/a><\/li>\n\t\t<li id=\"menu-item-261\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-261\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/cosmetic\/\">Cosmetics<\/a><\/li>\n\t\t<li id=\"menu-item-260\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-260\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/home-care\/\">Home Care Products<\/a><\/li>\n\t\t<li id=\"menu-item-262\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-262\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/semiconductor\/\">Semiconductors and Electronic Devices<\/a><\/li>\n\t\t<li id=\"menu-item-259\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-259\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/data_center\/\">Data Centers<\/a><\/li>\n\t\t<li id=\"menu-item-258\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-258\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/chemical_plant\/\">Chemical Plants<\/a><\/li>\n\t\t<li id=\"menu-item-5871\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5871\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/logistics\/\">Logistics<\/a><\/li>\n\t\t<li id=\"menu-item-5870\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5870\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/halal\/\">Halal<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-250\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-250\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/\">Cross Border Project Management<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-251\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-251\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/partners\/\">Alliance Partners in Southeast Asia<\/a><\/li>\n\t\t<li id=\"menu-item-252\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-252\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/partners_2\/\">Collaboration Partners in Europe and America<\/a><\/li>\n\t<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-266\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-266\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\">Consulting<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-272\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/gmdp_consulting\/\">Pharmaceutical GMP &#038; GDP Consulting<\/a><\/li>\n\t<li id=\"menu-item-271\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-271\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/qms_consulting\/\">QMS for Medical Devices<\/a><\/li>\n\t<li id=\"menu-item-274\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-274\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regulatory_affairs\/\">Regulatory Affairs Consulting<\/a><\/li>\n\t<li id=\"menu-item-267\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-267\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/qualification_validation\/\">Validation Consulting<\/a><\/li>\n\t<li id=\"menu-item-270\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-270\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regenerative_medicine\/\">Regenerative Medicine Consulting<\/a><\/li>\n\t<li id=\"menu-item-273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-273\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/contamination_control_strategy\/\">Contamination Control Strategy (CCS) Consulting<\/a><\/li>\n\t<li id=\"menu-item-5658\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5658\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\">Data Integrity (DI) Consulting<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-277\" class=\"jsLi noChild menu-item menu-item-type-post_type menu-item-object-page menu-item-277\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\">Education\/Training Support<\/a><\/li>\n<li id=\"menu-item-275\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-275\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/\">Technical Information Services<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-1872\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1872\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/corressa\/\">CORRESSA<\/a><\/li>\n\t<li id=\"menu-item-5851\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5851\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/energy_management\/\">Energy Management Solutions \u201cCMP Way\u201d<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/aside><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Home\/ Services\/ Consulting\/ Data Integrity (DI) Consulting ConsultingData Integrity (DI) Consulting What is Data Integrity? Data integrity refers to the completeness, consistency, and accuracy of data, and it is required to be ensured throughout the lifecycle of pharmaceuticals. To ensure data integrity, the principles of ALCOA+ are presented within various guidelines. Principles of ALCOA+ 1.Attributable: Data can be attributed to who did what, when, and where. 2.Legible: Data can be read by anyone. 3.Contemporaneous: Data is recorded and created at the time it occurs. 4.Original: Data is original or equivalent to the original. 5.Accurate: Data is recorded and created accurately. 6.Complete: All data exists, not just parts of it. 7.Consistent: [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":155,"menu_order":57,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[11],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Contamination Control Strategy(CCS) Consulting\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus\" \/>\n<meta property=\"og:description\" content=\"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\" \/>\n<meta property=\"og:site_name\" content=\"CM Plus\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-14T00:05:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2024\/05\/ogp.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"22 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\",\"url\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\",\"name\":\"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus\",\"isPartOf\":{\"@id\":\"https:\/\/cm-plus.co.jp\/en\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\",\"datePublished\":\"2025-01-10T06:57:58+00:00\",\"dateModified\":\"2025-01-14T00:05:49+00:00\",\"description\":\"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.\",\"breadcrumb\":{\"@id\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#primaryimage\",\"url\":\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\",\"contentUrl\":\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u30db\u30fc\u30e0\",\"item\":\"https:\/\/cm-plus.co.jp\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Services\",\"item\":\"https:\/\/cm-plus.co.jp\/en\/service\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Consulting\",\"item\":\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Data Integrity (DI) Consulting\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/cm-plus.co.jp\/en\/#website\",\"url\":\"https:\/\/cm-plus.co.jp\/en\/\",\"name\":\"CM Plus\",\"description\":\"Your Partner in Facility Construction, Quality Assurance, and GMP Education\/Training\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/cm-plus.co.jp\/en\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus","description":"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/","og_locale":"en_US","og_type":"article","og_title":"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus","og_description":"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.","og_url":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/","og_site_name":"CM Plus","article_modified_time":"2025-01-14T00:05:49+00:00","og_image":[{"url":"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2024\/05\/ogp.png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"22 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/","url":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/","name":"Contamination Control Strategy(CCS) Consulting\uff5cCM Plus","isPartOf":{"@id":"https:\/\/cm-plus.co.jp\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#primaryimage"},"image":{"@id":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#primaryimage"},"thumbnailUrl":"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp","datePublished":"2025-01-10T06:57:58+00:00","dateModified":"2025-01-14T00:05:49+00:00","description":"Experienced consultants in contamination control strategies provide support with services tailored to your specific challenges.","breadcrumb":{"@id":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#primaryimage","url":"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp","contentUrl":"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u30db\u30fc\u30e0","item":"https:\/\/cm-plus.co.jp\/en\/"},{"@type":"ListItem","position":2,"name":"Services","item":"https:\/\/cm-plus.co.jp\/en\/service\/"},{"@type":"ListItem","position":3,"name":"Consulting","item":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/"},{"@type":"ListItem","position":4,"name":"Data Integrity (DI) Consulting"}]},{"@type":"WebSite","@id":"https:\/\/cm-plus.co.jp\/en\/#website","url":"https:\/\/cm-plus.co.jp\/en\/","name":"CM Plus","description":"Your Partner in Facility Construction, Quality Assurance, and GMP Education\/Training","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/cm-plus.co.jp\/en\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/pages\/5633"}],"collection":[{"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/comments?post=5633"}],"version-history":[{"count":19,"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/pages\/5633\/revisions"}],"predecessor-version":[{"id":5662,"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/pages\/5633\/revisions\/5662"}],"up":[{"embeddable":true,"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/pages\/155"}],"wp:attachment":[{"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/media?parent=5633"}],"wp:term":[{"taxonomy":"keywords","embeddable":true,"href":"https:\/\/cm-plus.co.jp\/en\/wp-json\/wp\/v2\/keywords?post=5633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}