{"id":275,"date":"2026-10-26T16:02:56","date_gmt":"2026-10-26T10:32:56","guid":{"rendered":"https:\/\/incepbio.com\/blog\/?p=275"},"modified":"2026-10-26T16:20:42","modified_gmt":"2026-10-26T10:50:42","slug":"computer-system-validation-software","status":"publish","type":"post","link":"https:\/\/incepbio.com\/blog\/computer-system-validation-software\/","title":{"rendered":"Computer System Validation Software: 7 Key Factors for Pharma Buyers"},"content":{"rendered":"\t\t
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Choosing computer system validation software for a pharmaceutical environment requires more than document storage and approval workflows. The platform must support the evidence, traceability, access controls, and lifecycle records needed for your intended GxP use.<\/p>\n\t\t\n<\/div>\n

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This guide explains the capabilities to assess, the regulatory considerations to understand, and the questions to ask software suppliers before making a decision. It also examines how IncepBio\u2019s IncepOne platform aligns with these requirements, distinguishing published capabilities from features that require further confirmation.<\/p>\n\t\t\n<\/div>\n

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What Is Computer System Validation Software?<\/strong><\/h2>\n\t\t\n<\/div>\n
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Computer system validation software helps pharmaceutical teams organise and manage the documented evidence used to demonstrate that a computerised system is fit for its intended use. Depending on the platform, this may include validation documents, approval workflows, test records, traceability, and supporting evidence.<\/p>\n\t\t\n<\/div>\n

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Computer system validation (CSV) is the process of establishing and maintaining documented evidence that a computerised system meets its intended requirements. The software supports this process; it does not replace risk assessment, approved procedures or qualified judgement.<\/p>\n\t\t\n<\/div>\n

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Essential Capabilities of CSV Validation Software<\/strong><\/h2>\n\t\t\n<\/div>\n
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Treat each capability below as a requirement to test with suppliers, not an assumption.<\/p>\n\t\t\n<\/div>\n

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Lifecycle Documents, Workflows and Change Control<\/strong><\/h2>\n\t\t\n<\/div>\n
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Look for templates for validation plans, specifications, protocols, and reports, version control, and routed review and approval. Computerised systems keep changing, so the software should also record change impact assessments and scheduled periodic reviews that keep a system in its validated state after go-live.<\/p>\n\t\t\n<\/div>\n

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Traceability and Test Evidence<\/strong><\/h2>\n\t\t\n<\/div>\n
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CSV evidence is only as useful as its links. Check whether the software connects requirements, risks, test steps, results, and deviations, and whether failed tests and their resolution stay attached to the record.<\/p>\n\t\t\n<\/div>\n

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Audit Trails, E-Signatures and Access Control<\/strong><\/h3>\n\t\t\n<\/div>\n
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Confirm role-based permissions, time-stamped audit trails, and electronic signatures linked to the records they approve. Whether these meet Part 11 or Annex 11 expectations depends on configuration, procedures, and your scope. They are controls to assess, not guarantees.<\/p>\n\t\t\n<\/div>\n

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How Software Supports Risk-Based Validation<\/strong><\/h2>\n\t\t\n<\/div>\n
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Risk-based validation matches effort to each system's intended use and the consequences of failure. Software can help by recording GxP impact assessments and risk ratings, then tying test depth to them: scripted testing for high-risk functions and lighter assurance for low-risk ones. It can also keep the rationale beside the evidence. The software records the decision; qualified people make it.<\/p>\n\t\t\n<\/div>\n

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CSV Software vs eQMS, LIMS and Document Management Systems<\/strong><\/h2>\n\t\t\n<\/div>\n
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Not every pharmaceutical software platform serves the same purpose. A quality management system, laboratory information management system, and document management platform may support parts of the validation process, but their capabilities depend on the product and configuration.<\/p>\n\t\t\n<\/div>\n

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CSV-Focused Software<\/h3>\n

Evaluate whether it supports the validation lifecycle, requirements-to-test traceability, test evidence, review and approval records, and other deliverables required for your intended use.<\/p>\n <\/div>\n\n

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Electronic Quality Management System (eQMS)<\/h3>\n

Typically supports quality processes such as deviations, CAPA, change control, and document management. Check whether its validation-related workflows meet your specific needs.<\/p>\n <\/div>\n\n

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Laboratory Information Management System (LIMS)<\/h3>\n

Supports laboratory workflows and associated data. Its own GxP use may require validation, but that does not automatically make it a CSV lifecycle management tool.<\/p>\n <\/div>\n\n

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Document Management System<\/h3>\n

May control documents, versions, access, and approvals. Confirm whether it can also maintain the relationships between requirements, risks, tests, and results that your validation process needs.<\/p>\n <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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A platform may cover more than one category. Before selecting it, map your required deliverables and workflows against demonstrated product capabilities rather than relying on the product category or marketing description alone.<\/p>\n\t\t\n<\/div>\n

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Regulatory Considerations for Software Buyers<\/strong><\/h2>\n\t\t\n<\/div>\n
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Separate binding regulation from guidance when you write requirements.<\/p>\n\t\t\n<\/div>\n

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Applicable U.S. GMP Regulations<\/strong><\/h3>\n\t\t\n<\/div>\n
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\n\t\t\t\t\t\t\t\t\t\n21 CFR 211.68<\/a> requires appropriate controls over computers used in drug manufacturing, including limiting record changes to authorised personnel and checking input and output accuracy. 21 CFR Part 11<\/a> sets criteria for electronic records and signatures required by FDA rules. FDA’s scope and application guidance<\/a> describes a narrow reading of that scope, so decide which records fall under Part 11 before specifying controls.\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Guidance and Industry Practice<\/strong><\/h3>\n\t\t\n<\/div>\n
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\n\t\t\t\t\t\t\t\t\t\nEU GMP Annex 11 forms part of the EU GMP guidelines for computerised systems and should be read alongside the applicable pharmaceutical legislation. The European Commission\u2019s EU GMP Annex 11: Computerised Systems<\/a> is currently listed in EudraLex Volume 4 as the January 2011 revision.\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\nFDA\u2019s computer software assurance guidance<\/a> describes a risk-based approach for software used in medical device production and quality management systems. It is not a direct pharmaceutical GMP requirement. Pharmaceutical teams should determine their applicable regulatory obligations and apply appropriate risk-based validation principles within that context. ISPE GAMP 5, Second Edition<\/a> provides industry guidance; it is not a regulation.\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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How to Evaluate CSV Software: Selection Criteria<\/strong><\/h2>\n\t\t\n<\/div>\n
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Use the following checklist to compare suppliers consistently. The required capabilities will depend on the system\u2019s intended use, risk, and applicable procedures.<\/p>\n\t\t\n<\/div>\n

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Evaluation area<\/th>\nWhat to verify<\/th>\n<\/tr>\n<\/thead>\n
Intended use and risk<\/td>\nCan the supplier explain the platform\u2019s intended use, limitations, and validation responsibilities?<\/td>\n<\/tr>\n
Documentation<\/td>\nCan the platform manage the specific CSV deliverables your process requires?<\/td>\n<\/tr>\n
Traceability<\/td>\nCan you follow requirements, risks, tests, results and deviations through the record?<\/td>\n<\/tr>\n
Access and records<\/td>\nHow are user permissions, audit trails, electronic signatures and record retention handled?<\/td>\n<\/tr>\n
Change management<\/td>\nHow are software releases communicated, assessed and documented?<\/td>\n<\/tr>\n
Supplier responsibilities<\/td>\nWho manages configuration, access, support, backups and other operational tasks?<\/td>\n<\/tr>\n
Data export and exit<\/td>\nCan records and associated evidence be retrieved in a usable format if you change suppliers?<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Request a demonstration using a representative validation scenario\u2014record which requirements are demonstrated, which need configuration, and which are not supported.<\/p>\n\t\t\n<\/div>\n

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Before making a decision, ask each supplier these questions:<\/strong><\/p>\n\t\t\n<\/div>\n

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01<\/div>\n
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Can the platform manage the CSV deliverables, traceability, testing and approvals your organisation requires?<\/p>\n <\/div>\n <\/div>\n\n

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02<\/div>\n
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How does it handle changes, software releases, periodic reviews, access controls and data exports?<\/p>\n <\/div>\n <\/div>\n\n

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03<\/div>\n
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How are responsibilities divided between the supplier and your team, and what supporting documentation is available?<\/p>\n <\/div>\n <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Evaluating CSV Software for Your Pharma Operations?<\/strong><\/h2>\n\t\t\n<\/div>\n
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Choosing the right platform depends on your GxP requirements, validation workflows, and documentation needs. Contact IncepBio to discuss your computer system validation and digital compliance requirements.<\/p>\n\t\t\n<\/div>\n

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\n \n Discuss Your CSV Requirements\n <\/a>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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How IncepOne Fits CSV Software Requirements<\/strong><\/h2>\n\t\t\n<\/div>\n
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IncepBio describes IncepOne as a digital validation platform. Some of its published capabilities relate to document control, validation workflows, and digital approvals. However, these capabilities alone do not prove the platform meets every CSV-specific requirement. Buyers should assess the product against their intended use and verify relevant functions during a demonstration.<\/p>\n\t\t\n<\/div>\n

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Confirmed Capabilities<\/strong><\/h3>\n\t\t\n<\/div>\n
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\n\t\t\t\t\t\t\t\t\tAccording to IncepBio’s IncepOne product page<\/a>, the platform includes validation lifecycle tracking, workflow automation and dashboards, plus protocol templates, version control, review workflows and digital approvals. It also lists role-based access, audit trails, electronic-signature controls, a centralised document repository, a client portal and cloud hosting. These relate to the document control, workflow, and access requirements above.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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CSV Capabilities to Verify in a Demonstration<\/strong><\/h3>\n\t\t\n<\/div>\n
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IncepBio describes IncepOne in the context of digital validation, including HVAC and CQV workflows. Organisations considering it for CSV should ask the product team to demonstrate how the platform handles their required CSV deliverables.<\/p>\n\t\t\n<\/div>\n

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Key questions include:<\/strong><\/p>\n\t\t\n<\/div>\n

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Can requirements, risk assessments, test steps, results and deviations be linked?<\/p>\n <\/div>\n\n

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Can the platform support the CSV documents and approval records required by the organisation?<\/p>\n <\/div>\n\n

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How are changes, software releases and periodic reviews managed?<\/p>\n <\/div>\n\n

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What access, record-retention and data-export controls are available?<\/p>\n <\/div>\n\n

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Who configures, administers, supports and maintains the platform?<\/p>\n <\/div>\n\n

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What responsibilities remain with the customer, and what supporting documentation does the supplier provide?<\/p>\n <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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These questions should be answered using a demonstration and appropriate product documentation. The platform\u2019s suitability must be assessed for the organisation\u2019s intended use; purchasing software does not transfer the organisation\u2019s compliance responsibilities to the supplier.<\/p>\n\t\t\n<\/div>\n

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Conclusion<\/strong><\/h2>\n\t\t\n<\/div>\n
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Computer system validation software can help pharmaceutical teams organise validation evidence, maintain traceability and manage documentation. However, software alone does not establish compliance or replace risk assessment, approved procedures and qualified judgement. Evaluate each platform against your intended use, applicable regulatory requirements and demonstrated capabilities before making a decision.<\/p>\n\t\t\n<\/div>\n

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Frequently Asked Questions<\/strong><\/h2>\n\t\t\n<\/div>\n
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Does CSV software itself need to be validated? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Assess its intended use and GxP risk to determine the necessary validation activities and documentation.<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Does buying software make us Part 11 or Annex 11 compliant? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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No. Compliance depends on applicable requirements, system configuration, validation, procedures, and operation.<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Who is responsible when the platform is cloud-hosted? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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The regulated organisation retains responsibility for system oversight, while supplier responsibilities should be defined through agreements.<\/p>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Should pharma teams choose CSA instead of CSV? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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No. FDA\u2019s CSA guidance focuses on software used in medical-device production and quality management systems. Pharma teams should follow applicable GMP requirements and appropriate risk-based validation practices.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Can one platform manage both equipment qualification and CSV records? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Possibly. Verify that the platform supports the required documentation, traceability, testing, and approvals for both processes.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Choose the Right CSV Approach for Your Pharma Operations<\/strong><\/h3>\n\t\t\n<\/div>\n
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Every pharmaceutical organisation has different validation needs. Evaluate software against your GxP requirements, risk controls, documentation needs, and intended use before making a decision.<\/p>\n\t\t\n<\/div>\n

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\n Explore\n \n IncepBio\u2019s CSA and CSV services\n <\/a>\n to understand how they may support your computer system validation requirements.\n<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Choosing computer system validation software for a pharmaceutical environment requires more than document storage and approval workflows. The platform must support the evidence, traceability, access controls, and lifecycle records needed for your intended GxP use. This guide explains the capabilities to assess, the regulatory considerations to understand, and the questions to ask software suppliers before […]<\/p>\n","protected":false},"author":2,"featured_media":277,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[59,62,86,82,79,83,80,11,77,85,84,51,75,60],"class_list":["post-275","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-21-cfr-part-11","tag-computer-system-validation","tag-computerised-systems","tag-csv-software","tag-data-integrity","tag-digital-validation","tag-eu-gmp-annex-11","tag-gmp-compliance","tag-gxp-compliance","tag-incepone","tag-pharmaceutical-software","tag-pharmaceutical-validation","tag-risk-based-validation","tag-validation-documentation"],"_links":{"self":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/275","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/comments?post=275"}],"version-history":[{"count":11,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/275\/revisions"}],"predecessor-version":[{"id":288,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/275\/revisions\/288"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/media\/277"}],"wp:attachment":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/media?parent=275"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/categories?post=275"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/tags?post=275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}