Software Used by Pharmaceutical Companies

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Updated October 20, 2026

• Map pharmaceutical software by value-chain stage The table sorts 40 system classes into eight stages, from discovery research to commercial and medical teams, and adds our reading of each class's GxP status, owner and custom work in three further columns.
• GxP status follows records and use, not the product Regulations set requirements for records, controls and processes rather than naming software, so a system sits inside the validated boundary when it holds a record that a GMP, GDP, GCP or pharmacovigilance rule requires or is used as part of a regulated activity.
• Buy the system of record and build around it On our reading of the table, a company buys a commercial product for the regulated system of record, validates it for its intended use and builds where the workflow is specific to it or data crosses system boundaries. The custom work then goes into integrations, migrations, extensions, data platforms, AI layers with human review, validation evidence and apps for patients and HCPs.
• Standards define the seams between systems CDISC standards, HL7 FHIR, E2B(R3), IDMP, GS1 EPCIS and ISA-95 describe the main interfaces between pharmaceutical systems, which keeps integration work specific and testable.
• Clinical integrations sit inside GCP too E6(R3) wants computerized systems used in a trial to be fit for purpose, with risk-based validation where appropriate, so by this map's test any feed or data platform that carries trial data sits inside GCP alongside the EDC it connects to and should ship with validation evidence.

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In short: the software used by pharmaceutical companies is a chain of specialized systems, one or more per stage of the value chain. Research runs on electronic lab notebooks and laboratory information management systems (LIMS), clinical trials on a clinical trial management system (CTMS), electronic data capture (EDC) and an electronic trial master file, drug safety on a safety database and regulatory affairs on regulatory information management (RIM) and publishing tools. Manufacturing uses ERP, a manufacturing execution system (MES) and QC LIMS, quality uses an electronic quality management system (eQMS), the supply chain uses serialization systems and commercial teams use CRM. Read across the table below, our reading is that a pharmaceutical company buys a commercial system of record for each regulated function, validates it for its own intended use and commissions custom development around it: integrations, extensions, data pipelines and validation-ready tooling.

For the build side, see our pharma software development page.

What Software Do Pharmaceutical Companies Use?

The table lists 40 system classes across eight stages, naming classes rather than products and ranking no vendors. Its last three columns are Pharos Production's own reading, not a regulatory assignment. The GxP column applies the test set out in the next section: inside or outside the boundary, or depends when the answer turns on how a company uses the system. Ownership and custom work shift with company size, product type and outsourcing. No regulation cited here assigns these departments, although the rules name roles such as the regulated user and, in the EU, the Qualified Person who certifies batch release.

Our rule of thumb for the custom-work column: build where the workflow is specific to the company or data crosses system boundaries, and buy where a proven commercial product covers the regulated function, then validate it for the intended use. That is why the column describes work around each bought core rather than a replacement for it.

System class	Value-chain stage	What it does	Inside the GxP boundary? (our reading)	Typical owner	Where custom development usually happens
Electronic lab notebook (ELN)	Discovery and research	Records experiments and results as dated, attributable entries	outside	R&D informatics	LIMS and registration links, instrument capture, notebook migration
Research and bioanalytical LIMS	Discovery and research	Tracks samples, tests, results and chain of custody	depends	Lab informatics lead	Instrument integration, LIMS migration, cell therapy chain of identity
AI discovery and bioinformatics platforms	Discovery and research	Predict targets and properties, run sequencing pipelines	outside	Computational science teams	Assay data harmonization, feature stores, model serving
Clinical trial management system (CTMS)	Clinical development	Manages studies, sites, monitoring visits and investigator payments	inside	Clinical operations	EDC links, contract research organization (CRO) oversight dashboards, builds for CROs
Electronic data capture (EDC)	Clinical development	Captures case report forms with edit checks and queries	inside	Clinical data management	EHR-to-EDC eSource, lab feeds, extraction pipelines
eCOA and ePRO	Clinical development	Collect patient- and clinician-reported outcomes electronically	inside	Clinical operations	Wearable integration, apps for specific patient groups
eConsent	Clinical development	Delivers informed consent electronically with comprehension checks	inside	Clinical operations	Remote identity checks, localization
Interactive response technology (IRT)	Clinical development	Randomizes participants and manages trial supply	inside	Clinical supply chain	Forecasting models and depot links, rarely the core
Electronic trial master file (eTMF)	Clinical development	Keeps the trial master file inspection-ready	inside	TMF lead	Migrations, CRO handovers, document classification
Decentralized trial platforms	Clinical development	Support remote visits, home nursing and direct-to-patient shipment	inside	Clinical innovation	Patient apps, telehealth and logistics integrations
Clinical data platforms	Clinical development	Aggregate and reconcile EDC, lab, eCOA and IRT data	inside	Biometrics	Ingestion pipelines, safety and lab reconciliation
Statistical computing and CDISC tooling	Clinical development	Produce submission datasets and analysis outputs reproducibly	inside	Statistical programming	SDTM mapping automation, validated R and Python environments
Safety database	Safety and pharmacovigilance	Processes cases from intake to submission and feeds aggregate reports	inside	Drug safety operations	Migrations, intake integrations, aggregate report pipelines
E2B(R3) gateway	Safety and pharmacovigilance	Sends individual case safety reports (ICSRs) and processes acknowledgments	inside	Safety systems lead	Partner message validation, acknowledgment reconciliation
Signal detection and management	Safety and pharmacovigilance	Detects, evaluates and documents safety signals	inside	Safety scientists	Analytics on internal and regulator data
Literature monitoring and case intake	Safety and pharmacovigilance	Screen literature and extract cases from intake channels	inside	Pharmacovigilance operations	AI screening with human review, audit-ready logs
Regulatory information management (RIM)	Regulatory	Tracks registrations, submissions, commitments and variations	depends	Regulatory operations	Spreadsheet migration, change control links
eCTD publishing and gateways	Regulatory	Compile, validate and send submissions	depends	Regulatory publishing	Formatting and readiness checks upstream
IDMP and SPOR master data	Regulatory	Maintains standardized medicinal product data for EMA	depends	Regulatory data lead	Mapping from ERP and RIM, data-quality rules
Labeling (US SPL, EU ePI)	Regulatory	Authors and publishes structured product information	depends	Labeling lead	SPL and ePI generation, change tracking across markets
ERP	Manufacturing	Runs materials, production orders, inventory and batch status	inside	CIO, supply chain	MES, LIMS and serialization interfaces, ERP migration
MES and electronic batch records (EBR)	Manufacturing	Executes and records each batch against its master record	inside	Manufacturing IT	ERP, LIMS and equipment integration, batch data extraction
QC LIMS	Manufacturing	Manages QC testing, stability, release and certificates of analysis	inside	QC lab head	ERP quality links, certificate automation
Scientific data management (SDMS) and chromatography data systems	Manufacturing	Capture raw instrument data with metadata and audit trails	inside	QC lab head	File parsers, data lake ingestion, readable archives
Process analytical technology (PAT)	Manufacturing	Measures quality attributes in-line with multivariate models	inside	Process engineering	Spectrometer data pipelines, model monitoring
Operational technology (OT) data platforms and historians	Manufacturing	Connect equipment and process data for analytics	depends	Digital manufacturing	Plant data lakes, equipment connectivity
Electronic quality management system (eQMS)	Quality	Runs corrective and preventive actions (CAPA), deviations, change control and audits	inside	Head of quality	Deviations raised from LIMS, MES or ERP events
Document management and training	Quality	Controls standard operating procedures (SOPs) and training records	inside	QA	Migrations, HR system integration
Validation and data integrity tools	Quality	Produce validation evidence and review audit trails	inside	Computer system validation (CSV) lead	Test automation, requirement-to-test traceability
Serialization and aggregation	Supply chain	Puts unique identifiers on packs and aggregates them	inside	Packaging engineering	Line-to-site integration, contract manufacturer onboarding
Traceability and verification	Supply chain	Exchanges package data under DSCSA and verifies packs under EU rules	depends	Trade compliance	EPCIS ingestion, exception handling, warehouse links
Cold chain and good distribution practice (GDP) monitoring	Supply chain	Monitors temperature in storage and transport	inside	GDP or quality lead	Sensor integration, excursions into eQMS deviations
CRM and omnichannel engagement	Commercial and medical	Manages healthcare professional (HCP) accounts, calls, samples and consent	outside	Commercial excellence	CRM migration, HCP portals, consent centers
MLR review	Commercial and medical	Routes promotional material through medical, legal and regulatory review	outside	Commercial compliance	Pre-review that matches claims to references
Market access tools	Commercial and medical	Build value dossiers and health technology assessment evidence	outside	Market access, health economics and outcomes research (HEOR)	Web-based value tools, evidence data management
Aggregate spend and transparency	Commercial and medical	Reports transfers of value to HCPs	outside	Compliance	Pipelines from expenses, CRM and events
Medical information and medical science liaison (MSL) tools	Commercial and medical	Answer medical inquiries and capture field insights	depends	Medical affairs	Assistants over approved content, adverse event hand-off
Patient support program (PSP) platforms	Commercial and medical	Handle enrollment, benefits verification, nurse support and adherence	depends	Patient services	Patient and HCP portals, adverse event capture
Patient and digital therapeutics apps	Commercial and medical	Support medication use or, for digital therapeutics, treat a condition	depends	Brand team	App engineering, with intended use setting the regulatory load
Real-world data (RWD) platforms	Commercial and medical	Build evidence from claims, health records and registries	depends	Epidemiology, HEOR	Common data model pipelines, record linkage

Which Pharmaceutical Systems Fall Under GxP Rules?

A system falls under GxP (good practice) rules when it holds a record that a GMP, GDP, GCP or pharmacovigilance rule requires, or when it is used as part of a regulated activity, such as capturing trial data. No regulation cited here tells a pharmaceutical company which software to buy, because the rules attach to records, controls and processes in whichever system holds them. US drug current good manufacturing practice (CGMP) rules show the pattern in 21 CFR 211.68(b): "Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel". EU GMP Annex 11 covers every computerized system used as part of a GMP-regulated activity and states its core principle for them: "The application should be validated; IT infrastructure should be qualified."

FDA's Part 11 scope and application guidance reads Part 11 narrowly while still enforcing the predicate rules that create record requirements, which is why, under Part 11, the test is the record and not the product. By our reading, 23 of the 40 rows in the table sit inside the validated boundary, 11 depend on use and 6 sit outside it: two discovery classes and four commercial ones. An outside system moves inside once its data feeds a regulated record or decision. Custom work inside the boundary ships with validation evidence, while work outside it follows an ordinary engineering process.

Status snapshot (checked 2026-09-30): postmarketing ICSRs on human drug products, biological products and drug- or biologic-led combination products submitted to FDA through ESG NextGen must use E2B(R3) from October 1, 2026, as FDA announced in a Federal Register notice. ICH E6(R3) Annex 2 applies in the EU from January 15, 2027, per EMA's E6 guideline page, while at FDA it is still a draft guidance. The 2025 drafts of a revised EU GMP Annex 11 and of a new Annex 22 on AI went to a consultation that closed on October 7, 2025. Neither is adopted, and the EudraLex Volume 4 index still lists the 2011 Annex 11.

Discovery and Research Software

In our observation, notebooks and research LIMS are bought as products, and the custom work is plumbing such as instrument data capture. Nonclinical study data has its own CDISC standard, SEND, which CDISC describes as an implementation of SDTM for nonclinical studies.

AI discovery platforms are a different case. FDA's draft guidance on AI for regulatory decision-making leaves AI used for drug discovery outside its scope. The work there is engineering, assay data harmonization for example, with the client's scientists owning the methods.

Clinical Development Systems

ICH E6(R3) frames the whole stage, and EMA's Step 5 copy asks that computerized systems used in trials be fit for purpose, with risk-based validation where appropriate, and that responsibilities for each system be clear and documented.

EDC holds the case report forms. FDA's guidance on electronic source data describes their status: "The eCRF is an auditable electronic record of information that generally is reported to the sponsor on each trial subject". In our observation, sponsors rarely build EDC, but they pay for what feeds it and what it feeds: eSource from health records, central lab and eCOA transfers and extraction into clinical data platforms.

Trial master file systems carry a validation expectation of their own. EMA's TMF guideline says: "The eTMF systems should be validated to demonstrate that the functionality is fit for purpose". Randomization systems can do more than logistics. EMA's guideline on computerized systems in clinical trials notes: "Where the IRT system is collecting clinical data, important data should be subject to source data verification". In our assessment, sponsors leave the IRT, eTMF and eConsent cores to specialist products as well, and commission migrations, forecasting models and CTMS links alongside them.

CDISC describes SDTM and ADaM each as one of the required standards for data submission to FDA and Japan's PMDA. FDA's study data guidance points to its Data Standards Catalog for the standards it can process. Clinical data platforms and statistical tooling, which turn EDC, lab, eCOA and IRT data into CDISC datasets, are where we see custom builds cluster. Decentralized trial platforms add remote visits and home nursing, which ICH E6(R3) Annex 2 covers alongside pragmatic elements and real-world data, with its EU and FDA status given in the snapshot above. In the EU, trial applications go through the Clinical Trials Information System.

Safety and Pharmacovigilance Systems

For postmarketing ICSRs sent to FDA through ESG NextGen, a Federal Register notice announced E2B(R3) as the required format, with the product scope and date given in the status snapshot above. EudraVigilance accepts no E2B(R2) messages. FDA's testing guide has gateway partners validate E2B(R3) test files generated from their safety database with FDA's validator, so generation, validation and transport can be built as separate components.

Intake is where volume and rules meet. EU GVP Module VI sets a cadence for literature screening: "Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week". That weekly expectation is an EU one.

Screening at that pace, plus case intake from email, calls and patient programs, is, in our observation, a frequent candidate for AI tooling. CIOMS Working Group XIV lists human oversight among the seven guiding principles of its report on AI in pharmacovigilance. Tools built for this should, in our view, keep a person reviewing each extraction. For signal management, EU GVP Module IX expects marketing authorization holders to monitor EudraVigilance data to the extent they have access, which adds an external feed to the internal case data.

Regulatory Affairs Systems

FDA's CDER and CBER accept new applications in eCTD v4.0 as an option, and EMA's eSubmission site plans mandatory v4.0 use for new marketing authorization applications for centrally authorized products, with v3.2.2 accepted during the transition. Publishing tools, in our observation, are bought, and the build is the formatting and readiness check upstream.

Product master data is one area where EU law names a standard. EMA's IDMP overview states: "Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges European Union (EU) Member States, marketing authorisation holders and EMA to make use of the ISO IDMP standards." EMA implements those standards in phases through its SPOR master data services, which makes IDMP a mapping and data-quality job across ERP, RIM and labeling.

The US and the EU each define a structured electronic format for product information, and in the US it is already in use through SPL. FDA's SPL resources page describes Structured Product Labeling (SPL) as a document markup standard approved by Health Level Seven (HL7) and adopted by FDA for exchanging product and facility information.

In the EU, electronic product information (ePI) uses a semi-structured format whose common standard is based on FHIR, and EMA has published its guidance for submitting ePI for centrally authorized medicines ahead of go-live. Once ePI is live, we expect generating SPL and ePI from one content source to be a typical build.

Manufacturing Systems From ERP to the Shop Floor

ERP plans materials and orders, the MES executes each batch against its master record and QC LIMS holds the test results behind release, which in the EU a Qualified Person certifies. Under 21 CFR 211.188, "Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch". The QC lab carries a record duty of its own: under 21 CFR 211.194(a), laboratory records must include complete data from all tests needed to show compliance with specifications and standards, so the test data that an SDMS or chromatography system captures there belongs to that record.

In our assessment, MES and batch record cores are configured by the product's specialists. Custom work sits at their interfaces, and equipment connections can run over OPC UA, covered in our OPC UA integration guide.

Plant data platforms follow the same test. FDA's PAT guidance describes PAT as a way to control manufacturing by measuring critical quality and performance attributes while processing is under way. A historian that only serves analytics, with no GMP record or decision depending on it, can be built as an ordinary data platform. Once its data supports a batch or quality decision, it enters the validated boundary, with the extent of validation set by a documented risk assessment.

Quality Systems and Validation Tooling

ICH Q10 expects a CAPA system and an effective change management system, in the sense of a process rather than a product. EU GMP Chapter 4 accepts electronic documentation with controls for its accuracy, integrity, availability and legibility. The eQMS builds we see are mostly the integration that raises a deviation from a LIMS, MES or ERP event.

Validation tooling is the exception, because every custom GxP component needs evidence. Annex 11 expects the regulated user to take all reasonable steps to ensure a system was developed under an appropriate quality management system and to assess the supplier. FDA's data integrity questions and answers expect staff who review CGMP records to review the related audit trails too. Test automation that produces objective evidence, requirement-to-test traceability and audit-trail review tooling follow from both.

Supply Chain and Traceability Systems

FDA's DSCSA page summarizes the US law: "The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain."

The EU uses a repository model. Under Delegated Regulation (EU) 2016/161, packs of prescription medicines not exempted in its Annex I, of the non-prescription medicines listed in its Annex II and of any product a Member State has brought into scope carry a unique identifier and an anti-tampering device. The regulation provides for verifying a unique identifier by comparing it with the legitimate identifiers stored in a repositories system.

In our observation, serialization and verification platforms are bought, while cold chain monitoring carries more engineering. On the traceability side the custom work is integration, such as exception handling when product arrives without matching data. In the US, FDA's draft guidance on DSCSA standards recommends GS1 EPCIS for the data exchange, a recommendation rather than a requirement. EMA describes good distribution practice as the minimum standards a wholesale distributor must meet to keep medicine quality and integrity across the supply chain. One way to show that in transit is to join sensor data, excursion rules and eQMS deviations in one workflow, which is IoT development work.

Commercial, Medical and Patient Services Software

By our reading, four of the eight commercial and medical classes sit outside GxP and the other four depend on whether they handle safety or trial data, but several carry rules of their own. Promotional material goes through medical, legal and regulatory (MLR) review, and in the US an NDA applicant must file specimens under 21 CFR 314.81(b)(3)(i): promotional labeling at its initial dissemination and prescription drug advertisements at their initial publication.

Open Payments is a US national disclosure program, so aggregate spend systems pull transfers of value from expenses, CRM and events. Market access teams build evidence for EU joint clinical assessments, which began with new cancer medicines and advanced therapy medicinal products.

In our observation, medical information teams and patient support programs are regular sources of adverse event reports, so both need a route into the safety database. EU GVP Module VI, applying the ICH E2D definition, classes reports from patient support programs as solicited: "solicited reports of suspected adverse reactions are those derived from organised data collection systems, which include clinical trials, non-interventional studies, registries, post-approval named patient use programmes, other patient support and disease management programmes". For a PSP platform, that route should be a tested hand-off.

Privacy and device rules depend on role and intended use. For HIPAA, 45 CFR 160.103 defines covered entities as health plans, health care clearinghouses and providers that transmit health information electronically in covered transactions, and business associates as those who handle protected health information on a covered entity's behalf. FDA, quoting the IMDRF definition, describes software as a medical device as software intended for medical purposes that performs them without being part of a hardware medical device. Intended use therefore decides whether a patient app is engineered under a device quality system such as FDA's QMSR.

How Pharmaceutical Systems Connect

We see most custom work sit on a handful of interfaces between these systems. Each seam below has a standard or a regulatory text behind it, and that is what keeps the work specific enough to test.

• Clinical sites can feed EDC through eSource. FDA's guidance on EHR data in clinical investigations names the interoperability of EHR and EDC systems among its objectives, and HL7 describes FHIR as a standard for exchanging healthcare information electronically.
• The Part 11 line sits at the sponsor's system. FDA's Part 11 questions and answers for clinical investigations separate the two sides: "FDA does not intend to assess compliance of an electronic health record (EHR) system", but the agency intends to assess Part 11 compliance once the record enters the sponsor's EDC system. Our EHR integration guide covers the hospital side.
• Study builds start from the protocol. ICH M11 adds a technical specification of protocol data elements for electronic exchange, and CDISC's Digital Data Flow work defines the Unified Study Definitions Model as a reference architecture for digital protocol standards.
• For submissions to FDA and Japan's PMDA, clinical data moves through CDISC standards: CDASH can structure collection, and SDTM, ADaM and Define-XML carry the submission. CDISC's Define-XML page states: "Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission".
• ERP and MES meet at the boundary ISA-95 defines. From ISA's description of the standard: "The interface considered is between level 3 manufacturing systems and level 4 business systems in the hierarchical model defined in Part 1".
• Safety cases sent to EudraVigilance, or to FDA through ESG NextGen, leave as E2B(R3) messages, and product data flows from RIM into IDMP master data and labeling.
• Serialization systems can pass package data to US trading partners as EPCIS events, the standard FDA's draft guidance recommends, while EU packs are checked against the repositories system. LIMS, MES and ERP events can open deviations and change requests in the eQMS, feeding the CAPA and change management processes that ICH Q10 describes.

Where Pharmaceutical Companies Commission Custom Software

On our reading of the table, the work a company commissions around the system of record it buys and validates takes eight recurring forms.

• Integrations between systems from different suppliers, where most of the interfaces above are found.
• Migrations, including legacy modernization after a merger.
• Extensions on a platform's own APIs.
• Validation evidence: automated tests, requirement-to-test traceability and evidence captured in the delivery pipeline.
• Data platforms for clinical, safety, manufacturing and real-world data.
• Generative AI layers for intake, literature screening and drafting, with a person checking each output.
• Portals and apps for patients, healthcare professionals and trial sites.
• Product engineering for vendors that sell eClinical, decentralized trial or pharmacovigilance platforms.

Commissioning the work does not move regulatory responsibility. EU GMP Chapter 7 states: "The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities." For software, Annex 11 section 3.1 requires a formal agreement with any third party that provides, configures, validates or maintains a computerized system, and that agreement should state the third party's responsibilities.

For clinical systems, ICH E6(R3) keeps the duty with the sponsor or investigator and has them brief whoever builds the system: "The responsible party should ensure that those developing computerised systems for clinical trials on their behalf are aware of the intended purpose and the regulatory requirements that apply to them."

In practice that means validation-ready delivery. The builder traces requirements to tests and records every change. The client, as the regulated user, stays accountable for validation, usually through its QA team, and can then assess the supplier without reconstructing the build history.

How Pharos Production Helps

Pharos Production takes on the custom work described above and delivers it validation-ready: requirements traced to tests, change records and software development lifecycle (SDLC) evidence go to the client's QA team, while validation stays with the client as the regulated user. Our pharmaceutical software development services page covers engagements, while our software integration services, QA services and healthcare IT solutions teams cover single capabilities.

Sources: eCFR, 21 CFR Part 11, 211 and 314; FDA, Part 11 scope and application, Part 11 questions and answers for clinical investigations and electronic source data guidances; EMA, ICH E6(R3) Step 5 and GVP Module VI; European Commission, EudraLex Volume 4 Annex 11 and Chapter 7. Other sources are linked where cited. Engineering guidance, not regulatory or legal advice.

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Last updated: October 20, 2026

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• What is pharmaceutical software?

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  Pharmaceutical software is any system a drug company uses to research, develop, test, register, make, distribute, monitor or sell medicines. It includes regulated systems of record, such as a safety database or a manufacturing execution system, and tools outside GxP rules, such as research analytics or commercial CRM.

  The deciding question is whether the system holds records that a good practice rule on manufacturing, distribution, clinical trials or pharmacovigilance requires, or is used to carry out one of those regulated activities.

• Do regulations require pharmaceutical companies to use specific software?

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  No. The rules we reviewed set duties for records, controls and processes, not product categories. US drug CGMP requires controls over computer systems so that only authorized personnel change master production and control records, and EU GMP Annex 11 expects the application to be validated and its IT infrastructure qualified, whatever product a company chooses.

• Which pharmaceutical systems are usually custom built?

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  On our reading of this map, few systems of record are. Companies buy the EDC, IRT, eTMF, eQMS and MES cores and validate them for their intended use, and what they commission is the work around those cores, from interfaces to data platforms.

  Technology vendors that sell to the industry are the exception, because they build the products others buy.

• What is the difference between an ELN and a LIMS?

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  An ELN is the scientist's record of the work itself: what was tried, under which protocol and with what result, each entry dated and attributed. A LIMS follows the material, meaning samples and tests from receipt through results, with chain of custody.

  Research groups can run both, and linking them lets a sample registered in the LIMS be traced to the experiment recorded in the notebook.

• Who validates software that a vendor builds for a pharmaceutical company?

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  The pharmaceutical company, as the regulated user, stays accountable for validation and for the work it outsources. A vendor may do validation work or supply the documentation, which the company reviews before relying on it, and under EU GMP the two sides need a formal agreement that states the vendor's responsibilities.

• Which systems does a company that outsources to a CRO or CDMO usually not run itself?

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  In our observation, a sponsor that outsources a trial often works in the CRO's EDC, IRT and eTMF instead of running its own, and keeps an oversight layer: a CTMS view of CRO data, KPI and reconciliation checks and the trial master file handed over at closeout. A company that outsources manufacturing usually leaves the MES, batch records and QC LIMS to the CDMO and keeps its own eQMS and the serialization data it exchanges with the CDMO.

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