Evidence for systems that carry regulated work.
Reporting on the authorities, standards, systems, product changes, and operating decisions shaping regulated quality and regulatory work.
Kivo documents submission structures, content placeholders, a blinded-or-unblinded toggle, tracking spreadsheets, and export to publishing partners or software. A handoff still needs an approved content inventory, artifact-level blinding state, immutable transfer manifest, and receiver reconciliation before it can be treated as complete or appropriately disclosed.
Scilife describes controlled printing and reconciliation alongside its document-management workflows. A printed copy still needs a durable identity, point-of-use owner, issuance history, reconciliation state, and retirement evidence before teams can know which instruction was available for regulated work.
Generis presents CARA as one governed platform spanning regulatory, quality, safety, and clinical processes, with shared records and audit trails. The same underlying record can reduce re-entry, but each configured process still needs intended-use, migration, access, workflow, calculation, report, interface, and exception evidence before the organization can rely on it for regulated work.
EMA says the PLM web-based electronic Application Form becomes mandatory for human Centrally Authorised Product variation submissions on September 1, 2026, with justified technical exceptions for continued interactive-PDF use. Regulatory operations need to preserve the applicable form path, impediment, support evidence, submission package, and receipt outcome as separate controlled facts.
ArisGlobal presents LifeSphere Regulatory as an end-to-end environment for regulatory data, content, submissions, labeling, planning, tracking, and health-authority interactions. Connecting those records can improve oversight, but an incoming question, an outgoing response, a promised action, and completion evidence still need distinct identities, owners, dates, and approval states.
FDA labels Draft CVM GFI #256B as not for implementation and says it contains nonbinding recommendations for comment. The draft describes a future enforcement policy for certain animal drugs compounded from bulk substances in federally registered facilities, while stating that FDA generally would not intend to exercise enforcement discretion for current good manufacturing practice violations at those facilities.
ETQ presents audit management, quality events, nonconformance handling, CAPA, change, and release work in a configurable quality platform. Linking those workflows can reduce handoff loss, but an audit finding, immediate containment, systemic corrective action, and effectiveness conclusion remain different evidence states.
Kneat presents a digital platform for GxP validation requirements, testing, execution, review, traceability, and lifecycle change. An exception can reach a closed workflow state after investigation and planned correction, but the validated record still needs to show whether the affected requirement was retested under the approved conditions and what result was actually observed.
QT9 presents complaint handling with investigation, closure, escalation, and adverse-event reporting support inside its pharmaceutical QMS. Connecting those activities can reduce handoffs, but closing the quality complaint must not imply that a separate reporting assessment, submission, follow-up, or documented no-report decision is complete.
Rimsys presents regulatory intelligence, product data, approvals, submissions, UDI, and change management as a connected regulatory information environment for medtech. Connection can speed impact analysis, but a new signal or proposed change should not silently rewrite the product and registration state that was actually approved.
Dot Compliance presents Dottie as an AI quality and compliance guide within its life-sciences eQMS, alongside ready-to-use modules and quality workflows. Guidance may accelerate review, but the regulated record still needs attributable source evidence, qualified judgment, approval authority, and a preserved path from suggestion to decision.
Honeywell describes TrackWise PQR as automating Annual Product Quality Review work and TrackWise QMR as providing near-real-time metrics for management reviews. Connecting both can improve visibility, but a current metric, a periodic product review, and an authorized management conclusion answer different questions.
Ennov presents its Quality Suite as one application for managing and tracking quality documentation, processes, and data, with document management, quality management, and training in the suite. A unified record can make work visible and reviewable, but it does not by itself establish that a configured process was suitable, followed, or effective for its intended regulated use.
Greenlight Guru presents a medical-device platform connecting design controls, risk, product traceability, documents, training, suppliers, quality events, and CAPA. Linked evidence can make a release review reconstructable, but the links do not establish that requirements were met or authorize a device to move forward.
Qualio describes gap analysis, cross-mapped evidence, regulatory monitoring, and quality workflows in one platform. Reusing evidence can reduce duplicate work while each requirement still needs a current scope, implemented process, operating record, qualified review, and defensible conclusion.
Veeva describes a single cloud platform spanning quality assurance, quality control, and training. Connected records can reduce handoff friction without making a document approval, investigation conclusion, laboratory result, and training completion interchangeable.
A digital validation lifecycle can connect plans, execution, review, and evidence without making an approved package permanent proof that the process remains controlled after change.
A shared compliance environment can connect quality and regulatory work without turning a quality disposition into a registration decision—or a regulatory status into quality approval.
MasterControl documents configurable quality-event forms, rules-based routing, connected quality records, and AI-supported summaries and trend identification. Those functions can organize investigation, but the event, related change or training record, root-cause conclusion, and accountable disposition should remain separately evidenced.
Veeva documents one shared platform and data model across four regulatory applications. That connection should preserve the different states of a registration, submission plan, published dossier, authority correspondence, and historical archive.
Regulation (EU) 2017/746 connects scientific validity, analytical performance, clinical performance, post-market follow-up, and lifecycle updates. One completed study or stored report cannot stand in for that maintained evidence chain.
The drug CGMP definitions connect a lot number to a batch or lot's complete manufacturing and distribution history. That identifier supports traceability, but it does not by itself show that acceptance criteria were met or that quality authorized release.
The finished-pharmaceutical CGMP rule connects qualification and continuing training to assigned functions and the operations a person performs. A completed annual course, learning-system badge, or attendance total does not by itself establish that qualification.
ISO IDMP defines data structures for identifying and exchanging medicinal-product information. It does not approve a medicine, establish its current authorization status, or show that a dossier or authority submission is complete.
ISO's current record defines a medical-device quality-management-system standard for organizations across the lifecycle. It does not certify an application or make a configured workflow conforming by itself.
Articles 83 through 86 connect device-lifecycle surveillance, technical documentation, corrective action, and class-specific reporting instead of leaving post-market data in a separate complaint archive.
The guideline assigns the pharmaceutical company responsibility for controlling outsourced activities and purchased materials through prior assessment, written responsibilities, monitoring, and review.
The production-record rule connects quality-unit review, batch release, investigation beyond the first affected batch, written conclusions, and follow-up instead of allowing a passing final result to erase an unexplained event.
The pharmaceutical quality-system model connects a proposed change to risk-based evaluation before implementation and a check afterward that objectives were achieved without harming product quality.
Annex 11 requires formal responsibility boundaries when third parties support GMP computerised systems. A vendor package cannot substitute for the regulated user's lifecycle evidence.
Part 11 applies to specified electronic records and signatures in an FDA-regulated context. A system label cannot replace the first question: which record requirement, use, and retention obligation is in scope?
ICH Q9(R1) treats risk as a lifecycle decision process, including computerized systems. Buyers should test evidence, review triggers, and human authority.
The July release carries bug fixes and sits inside a broader transition toward structured application data, new MAA forms, and mandatory PLM web-based eAF use for centrally authorised product variations.
The July package refresh adds forward-compatibility samples and revises regional vocabulary, conformance, and transmission materials for a standard FDA already accepts for new applications.
The June release expands access to structured medicinal-product data while marketing authorisation holders face staged manufacturer and pack-data enrichment deadlines.
The transition moves actor, device, certificate, and market-surveillance records from voluntary use into required EU operating workflows, increasing the cost of disconnected regulatory data.
The February guidance focuses assurance effort on software risk and confidence rather than prescribing one validation-document package, giving buyers a sharper way to examine vendor evidence and intended use.
The rule now incorporates ISO 13485:2016 by reference and replaces QSIT with a new inspection process, shifting the questions device manufacturers should ask of quality systems and evidence.
The January transition changes classification and procedure rules for post-authorisation changes, forcing regulatory operations teams to align systems, forms, content, and implementation dates.
Draft revisions to Chapter 4 and Annex 11, plus a proposed Annex 22 for artificial intelligence, signal the direction of travel—but remain consultation drafts rather than operative requirements.
