PharmaCap Digital Capability Framework Overview

Detailed Process Guide

Explore Every Capability

Select a layer to explore capability areas and their six-step process descriptions in detail.

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Layer 01

Stakeholder & Market Engagement

Digital experience management, omnichannel marketing, stakeholder engagement, and external integration capabilities enabling meaningful interactions across HCPs, patients, and partners.

Digital Experience & Information

Web Portals

Define portal architecture, user personas and access tiers for HCPs, patients and partners.
Design and implement responsive UI/UX with brand-compliant templates.
Configure role-based authentication, SSO integration and session management.
Publish, version and retire content pages following a structured approval workflow.
Monitor uptime, page performance and accessibility compliance (WCAG 2.1).
Collect user feedback and analytics to drive iterative improvements.

HCP / Patient Portals

Onboard healthcare professionals and patients through identity-verified registration.
Integrate EHR/EMR data feeds to personalise clinical content and treatment history.
Provide secure messaging, prescription refill requests and appointment scheduling.
Deliver medication adherence reminders, educational resources and safety alerts.
Enforce HIPAA/GDPR data-handling controls and audit trails.
Measure portal engagement KPIs and patient satisfaction scores monthly.

Web Content Management

Maintain a content taxonomy aligned with therapeutic areas and product brands.
Manage editorial calendar, content creation, review and MLR approval.
Publish multilingual content with localisation review for regional compliance.
Govern content expiration, archival and removal through lifecycle workflows.
Integrate CMS with DAM and PIM to surface rich media and product data.
Track content performance via SEO metrics, page views and conversion rates.

Digital Asset Management

Ingest, tag and categorise all brand assets with metadata.
Enforce rights management, usage licences and expiry dates on each asset.
Provide self-service search and download portals for internal teams and agencies.
Version-control assets and maintain audit history for regulatory submissions.
Integrate DAM with CMS, marketing automation and email platforms.
Conduct quarterly asset audits to remove outdated or non-compliant materials.

Product Information Management

Establish a master product data model covering SKU, formulation, dosage and indication.
Onboard and validate product data from R&D, regulatory and manufacturing sources.
Manage multilingual product attributes for global market distribution.
Syndicate approved product data to portals, e-commerce and distributor catalogues.
Enforce data quality rules and trigger alerts for incomplete or conflicting records.
Review and update product data on every label change or new indication approval.

Customer Data Platform

Collect and unify first-party data from portals, CRM, events and digital channels.
Build consolidated HCP and patient identity profiles with consent records.
Segment audiences based on specialty, prescribing behaviour and engagement history.
Activate audience segments across email, paid media and sales tools in real time.
Enforce consent management, data residency and opt-out processing automatically.
Provide analytics on segment performance, identity match rates and channel attribution.

Omnichannel Marketing

Email / Web / Social Campaigns

Plan campaign briefs aligned to brand strategy and market access milestones.
Develop campaign content through cross-functional MLR review and approval.
Configure audience targeting using CDP segments and CRM data.
Deploy campaigns across email, web banners and social channels.
Monitor deliverability, open rates, CTR and social engagement in real time.
Generate post-campaign reports; iterate creative and targeting based on learnings.

Journey Orchestration

Map customer journeys by HCP archetype from awareness through prescribing adoption.
Design multi-step orchestration flows combining digital and field touchpoints.
Define entry, exit and branching logic based on behavioural and engagement signals.
Coordinate journey triggers with MSL visits, congresses and scientific exchange events.
Monitor journey progression, drop-off rates and next-best-action effectiveness.
Optimise journeys quarterly using engagement analytics and field feedback.

Personalization

Define personalisation use cases by segment: specialty, treatment stage, geography.
Implement real-time decisioning engine to select content variants per individual.
Deliver personalised content on portals, emails and sales rep tools dynamically.
Manage personalisation rules, fallback logic and consent boundaries centrally.
Measure lift in engagement and prescription intent from personalised experiences.
Conduct ethics and compliance review of personalisation rules bi-annually.

Digital Advertising

Define paid media strategy across search, display, programmatic and social platforms.
Configure audience targeting using third-party data, lookalike modelling and retargeting.
Submit ad creatives through MLR review before trafficking to ad platforms.
Manage campaign budgets, bid strategies and pacing using media management tools.
Monitor impressions, reach, frequency, ROAS and adverse event reporting.
Optimise campaigns weekly; reconcile spend against budget and adjust channels.

Stakeholder Engagement

KOL Engagement

Identify and tier key opinion leaders using publication, trial activity and influence data.
Develop tailored engagement plans per KOL aligned to therapeutic area strategy.
Coordinate advisory boards, speaking engagements and scientific panel participation.
Document all KOL interactions in CRM with fair market value and compliance records.
Manage contracts, honoraria and disclosure obligations through legal review.
Measure KOL advocacy outcomes including publications and guidelines impact.

MSL Management

Recruit, onboard and train Medical Science Liaisons on therapeutic area and compliance.
Assign MSL territories based on HCP density, trial sites and scientific priority.
Equip MSLs with approved scientific content, clinical data summaries and presentation tools.
Log and document every MSL-HCP interaction for compliance and CRM accuracy.
Coordinate MSL activities with commercial teams while maintaining medical independence.
Evaluate MSL performance against engagement quality and reach KPIs.

Conference & Event Management

Develop annual congress and event calendar aligned to therapeutic and brand priorities.
Plan logistics: booth design, symposia sponsorship, abstract submission and speaker management.
Coordinate MLR review of all event materials and presentations before deployment.
Manage on-site operations: registration, HCP engagement and adverse event reporting.
Capture leads, interaction data and congress insights into CRM post-event.
Conduct post-event ROI analysis covering attendance, engagement and scientific impact.

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Layer 02

Drug Development & Lifecycle Management

End-to-end capabilities from early target identification through clinical development, regulatory submissions, pharmacovigilance, and product lifecycle strategy.

Research & Discovery

Target Identification

Conduct genomic, proteomic and phenotypic screening to identify disease-relevant biological targets.
Evaluate target tractability, novelty and freedom-to-operate through bioinformatics analysis.
Build target dossiers aggregating literature, patent and competitive intelligence data.
Prioritise targets through multi-criteria scoring integrating scientific and commercial value.
Initiate target validation studies (in vitro, in vivo, genetic models) to confirm disease link.
Document target selection decisions in electronic lab notebooks for IP and regulatory traceability.

Biomarker Discovery

Define biomarker strategy (predictive, prognostic, pharmacodynamic, safety) for each programme.
Collect and bank biological samples under IRB-approved protocols.
Apply multi-omics platforms (genomics, transcriptomics, proteomics, metabolomics) to discover signatures.
Statistically validate biomarker candidates using training and independent validation cohorts.
Develop and qualify analytical assays (ELISA, NGS, mass spectrometry) to measure biomarkers.
Submit validated biomarker data to regulatory agencies as part of CDx development strategy.

Preclinical Research

Design in vitro and in vivo studies to characterise mechanism of action and efficacy.
Select species and study designs in alignment with ICH and OECD guidelines.
Execute GLP toxicology studies at qualified sites.
Analyse PK/PD data to establish exposure-response relationships and safe starting doses.
Compile preclinical package for IND/CTA filing covering safety pharmacology and toxicology.
Archive raw data and study reports in validated systems per 21 CFR Part 11.

Clinical Development

Trial Design

Define clinical development plan (CDP) aligning endpoints, populations and study designs to regulatory strategy.
Conduct protocol design workshops with biostatistics, clinical, regulatory and patient advocacy teams.
Develop statistical analysis plan (SAP) specifying primary/secondary endpoints and sample size.
Submit protocols to IRB/IEC, competent authorities and data monitoring committees for approval.
Design eCRF, randomisation and blinding procedures in the EDC system.
Conduct protocol feasibility assessments at investigator sites prior to study initiation.

Patient Recruitment

Develop global patient recruitment strategy including site selection and enrolment projections.
Deploy digital recruitment channels (social media, patient registries, disease communities).
Implement pre-screening tools and eligibility check workflows to reduce screen failure rates.
Monitor enrolment rates at site and country level against planned timelines weekly.
Apply rescue strategies (protocol amendments, additional sites) when behind target.
Track diversity and inclusion metrics in enrolled population against pre-defined targets.

Trial Monitoring

Develop risk-based monitoring (RBM) plan defining remote and on-site monitoring triggers.
Conduct remote centralised monitoring of data trends, outliers and protocol deviations.
Perform on-site monitoring visits (SIVs, IMVs, COVs) with structured monitoring reports.
Escalate critical findings to sponsor management and site immediately with CAPA tracking.
Validate source data verification (SDV) completeness against protocol-defined thresholds.
Aggregate monitoring metrics to assess trial quality and adjust monitoring frequency dynamically.

Regulatory Affairs

Regulatory Strategy

Develop global regulatory strategy covering target geographies, accelerated pathways and TPP alignment.
Engage with FDA, EMA and other authorities through pre-IND and Scientific Advice meetings.
Map regulatory requirements per jurisdiction and identify evidence package gaps.
Assess eligibility for Orphan Drug, Breakthrough, PRIME and other designation programmes.
Update regulatory strategy at each stage gate based on clinical data and authority feedback.
Coordinate regional regulatory strategies with affiliates and local regulatory representatives.

Submission Management

Plan submission timelines for IND, NDA/BLA, MAA and post-approval filings.
Coordinate cross-functional authoring teams for Module 2 summaries, Module 3 CMC and Module 5 clinical data.
Publish eCTD-compliant dossiers using validated publishing software and perform technical QC.
Transmit submissions electronically via ESG (FDA) or CESP (EMA).
Track submission status, questions lists and authority action dates in regulatory tracking system.
Manage post-submission queries with structured response plans and authority communication logs.

Pharmacovigilance

Establish global adverse event intake channels (call centres, medical information, literature, digital).
Triage all incoming safety reports for seriousness, expectedness and causality within 24 hours.
Report expedited serious adverse events to authorities within ICH E2A timelines (7/15-day rules).
Execute disproportionality analyses (PRR, ROR) on spontaneous databases monthly.
Develop Risk Management Plans (RMPs) and REMS at approval.
Compile and submit Periodic Safety Update Reports (PSURs/PBRERs) within authority-defined windows.

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Layer 03

Manufacturing & Supply Operations

GMP-compliant manufacturing, supply chain planning, distribution, quality management, packaging, and asset management capabilities supporting reliable product supply.

Manufacturing

Batch Manufacturing

Execute manufacturing batch records (MBRs) following approved SOPs and process parameters.
Manage in-process controls (IPCs) and release testing against pre-defined specifications.
Perform batch disposition through qualified person (QP) review and formal release decision.
Investigate OOS and OOT results with documented root cause analysis.
Maintain equipment logs, cleaning records and environmental monitoring data per GMP.
Archive completed batch records for the required regulatory retention period.

GMP Compliance

Maintain site GMP self-inspection programme with structured audit schedule and CAPA tracking.
Manage authority inspection readiness including mock inspections and response protocols.
Ensure all GMP documentation (SOPs, specifications, batch records) is current and approved.
Train all manufacturing personnel on GMP requirements, SOPs and data integrity principles.
Review and trend quality metrics (deviations, OOS, complaints, CAPAs) in monthly quality board reviews.
Submit annual product reviews (APRs) and support site regulatory filings as required.

Supply Chain Planning (S&OP)

Execute monthly S&OP cycle: demand review, supply review, pre-S&OP and executive S&OP meetings.
Align unconstrained demand plan to supply capacity; surface constraints and resolution options.
Integrate financial plan into integrated business planning (IBP) review.
Document S&OP decisions, assumptions and escalations with action owners and due dates.
Produce rolling 18–24 month supply plan outputs for manufacturing scheduling and procurement.
Measure S&OP process maturity and plan adherence KPIs; target continuous improvement annually.

Cold Chain Logistics

Define cold chain specifications (2–8°C, -20°C, -80°C, cryogenic) per product and route.
Qualify cold chain packaging systems and carrier lanes through temperature mapping.
Monitor cold chain shipments using IoT data loggers with automated temperature excursion alerts.
Assess and document temperature excursions through quality risk assessment.
Train logistics partners on cold chain handling, packing procedures and excursion response protocols.
Review cold chain performance data (excursion rate, packaging failure rate) quarterly.

Serialization

Implement item-level serialisation using GS1 DataMatrix codes per EU FMD, DSCSA and SFDA requirements.
Manage serial number allocation, assignment and commissioning through validated systems.
Aggregate serialised items into barcoded cases and pallets with parent-child hierarchies.
Report aggregation data to national medicines verification systems (NMVS, DSCSA trading partners).
Conduct serialisation audits at packaging lines to verify scan rates and data accuracy.
Manage serialisation master data (GTIN, NDC, NHRN) across markets and update on label changes.

CAPA Management

Initiate CAPAs from deviations, audits, complaints, regulatory inspections and trending analysis.
Define effectiveness criteria and metrics to evaluate whether the corrective action achieved its intent.
Assign CAPA owners, reviewers and due dates with escalation workflows for overdue items.
Implement and verify corrective actions with documented evidence before closure.
Conduct effectiveness checks at defined intervals post-closure to confirm sustained improvement.
Report CAPA cycle times, overdue rates and re-occurrence metrics in monthly quality reviews.

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Layer 04

Commercial & Revenue Operations

Customer relationship management, order-to-cash processes, market access, pricing strategy, and reimbursement capabilities driving commercial performance.

Customer Relationship Management

HCP Relationship Management

Maintain accurate HCP profiles covering specialty, affiliation, prescribing segments and contact preferences.
Execute call planning and territory alignment to optimise field force coverage and frequency.
Log all HCP interactions (visits, calls, emails) in CRM within 24 hours of occurrence.
Segment HCPs by potential, loyalty and prescribing behaviour to prioritise engagement resources.
Coordinate MSL, KAM and sales rep engagement to present a unified stakeholder experience.
Measure HCP satisfaction, relationship strength and segment share-of-voice quarterly.

Patient Support Programs

Design support programmes covering adherence, nursing, co-pay assistance and financial aid.
Enrol patients through HCP referral, digital channels and pharmacy integration workflows.
Provide multi-channel patient support via phone, app and nurse educator touchpoints.
Track programme enrolment, adherence rates, completion and patient outcomes.
Ensure programme compliance with anti-kickback, HIPAA and applicable state regulations.
Evaluate programme ROI by measuring adherence improvement, refill rates and brand loyalty impact.

Order-to-Cash

Receive and validate customer purchase orders via EDI, portal and manual channels.
Check inventory availability, credit limits and export licence requirements before order acceptance.
Process standard, rush and backorder orders through ERP with priority and routing rules.
Generate accurate invoices at shipment or order fulfilment trigger per customer billing terms.
Maintain rebate contracts with GPOs, government agencies, managed care and specialty distributors.
Track order fill rate, perfect order rate and on-time delivery metrics daily.

Market Access & Pricing

Pricing Strategy

Develop global reference pricing policy and IRP monitoring framework to manage cross-market price corridors.
Conduct value-based pricing analysis using willingness-to-pay research and QALYs gained.
Model net price scenarios under different contracting and rebate structures to optimise payer access.
Obtain internal price approval through governance committees before launch and price change filings.
Monitor competitor pricing and market access developments to update pricing positioning quarterly.
Report net price realisation, gross-to-net bridge and pricing variance to finance and leadership.

Reimbursement Strategy

Map payer landscape (national, regional, private) and decision-making processes per target market.
Develop payer dossiers and value dossiers tailored to each payer segment and system (AMNOG, SMC, HAS).
Engage payers early through scientific advisory boards and parallel scientific advice with HTA bodies.
Submit reimbursement applications with clinical and economic evidence packages within authority timelines.
Negotiate listing conditions, restrictions and managed entry agreements (MEAs) with payers.
Monitor reimbursement decision outcomes and access conditions against launch assumptions quarterly.

HEOR Analytics

Design health economic models (cost-effectiveness, budget impact) aligned to payer decision frameworks.
Collect and analyse real-world data to generate comparative effectiveness and cost outcomes evidence.
Publish HEOR findings in peer-reviewed journals and present at HTA advisory board meetings.
Develop country-adapted economic models and local cost inputs for each reimbursement submission.
Respond to payer technical economic model reviews and queries with methodological documentation.
Maintain and update economic models as new clinical data or real-world evidence becomes available.

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Layer 05

Enterprise Business Support

Finance, legal & compliance, HR workforce management, vendor governance, and program portfolio management enabling organisational effectiveness.

Finance

Budgeting & Financial Reporting

Execute annual budget cycle with bottom-up submission, consolidation and executive approval process.
Develop driver-based budget models linking commercial assumptions to revenue and cost forecasts.
Close the financial books monthly, quarterly and annually per IFRS or US GAAP requirements.
Prepare statutory financial statements and coordinate external audit engagements.
Ensure Sarbanes-Oxley (SOX) compliance through documented controls and quarterly testing.
Distribute board and investor reporting packages with supporting analysis and business narrative.

Treasury

Manage daily cash positioning and liquidity to meet operational funding requirements.
Execute foreign exchange hedging programmes to manage transactional and translational FX exposure.
Administer banking relationships, credit facilities and covenant compliance monitoring.
Invest surplus cash in approved instruments per treasury policy risk and liquidity guidelines.
Manage debt structure, refinancing timelines and counterparty credit risk.
Report treasury positions, hedging outcomes and liquidity metrics to CFO and Audit Committee.

Corporate Compliance

Develop and maintain a corporate compliance programme covering anti-bribery and competition law.
Conduct annual risk assessments to identify and prioritise compliance programme focus areas.
Deliver mandatory compliance training to all employees with completion tracking.
Manage the confidential ethics hotline and investigate reported concerns following established protocols.
Conduct third-party due diligence on HCP-facing vendors, distributors and commercial partners.
Report compliance programme performance and investigation outcomes to the Audit Committee.

HR / Workforce

Talent Management

Design and manage end-to-end recruitment process from job posting through offer acceptance.
Implement structured assessment processes (competency interviews, technical assessments).
Run early talent programmes (graduate, internship, rotation) to build future leadership pipeline.
Identify high-potential employees and implement targeted development plans and stretch assignments.
Manage succession plans for critical and executive roles with defined readiness timelines.
Track talent acquisition metrics (time-to-fill, quality-of-hire, diversity) and report monthly.

Performance & Compensation Management

Design goal-setting framework aligned to company OKRs or balanced scorecard.
Execute annual and mid-year performance review cycles with structured manager-employee dialogue.
Calibrate performance ratings across teams to ensure consistency and manage distribution guidelines.
Design competitive compensation structures (salary bands, bonus plans, long-term incentives) aligned to market benchmarks.
Conduct annual compensation benchmarking using third-party survey data.
Ensure pay equity through periodic pay equity analyses and remediation where gaps are identified.

Transparency Reporting

Collect and validate HCP/HCO transfer-of-value (TOV) data from all payment sources.
Reconcile TOV data against contractual records, expense reports and event management systems.
Obtain required HCP consent for public disclosure under EFPIA, Sunshine Act and local regulations.
Submit annual transparency reports to national authorities and industry body portals on time.
Publish HCP payment disclosures on required public platforms with accurate HCP identification data.
Respond to HCP queries and disputes regarding disclosed payments with a structured process.

⚙️

Layer 06

Digital Automation & Integration

Integration platforms, process automation, RPA, intelligent automation, and BPM capabilities enabling seamless digital operations across the enterprise.

Integration Platforms

API Gateway

Design and deploy API gateway as the single entry point for all internal and external API traffic.
Enforce authentication, authorisation, rate limiting and IP whitelisting policies at the gateway layer.
Publish and manage API lifecycle (design, test, deploy, deprecate) through developer portal.
Monitor API traffic, latency, error rates and SLA compliance with real-time alerting.
Apply request/response transformation, caching and routing rules to optimise API performance.
Conduct quarterly gateway security reviews including penetration testing and vulnerability assessment.

Event Streaming

Design event-driven architecture using streaming platforms (Kafka, Azure Event Hub, AWS Kinesis).
Define event schemas, topic naming conventions and retention policies in a schema registry.
Implement producer and consumer applications with idempotent processing and dead-letter queue handling.
Monitor stream lag, throughput and consumer group health with automated alerting.
Manage event streaming infrastructure for high availability.
Conduct capacity planning for event streaming volumes and review data retention costs quarterly.

RPA & Intelligent Automation

Identify and prioritise RPA candidates using process assessment (volume, rule-based, digital interface criteria).
Document process-specific automation design documents (PDD/SDD) before bot development.
Assess intelligent automation opportunities combining RPA with AI/ML, NLP and computer vision.
Train, validate and deploy AI/ML models within automation pipelines with version control.
Monitor model performance, drift and explainability in production automation processes.
Report intelligent automation value realisation (FTE savings, quality improvement, speed) quarterly.

BPM & Workflow Automation

Establish BPM centre of excellence with standards for process modelling, governance and improvement.
Model enterprise processes using BPMN 2.0 tooling and publish in process repository.
Conduct process performance analysis using BPM analytics to identify bottlenecks and waste.
Execute process improvement cycles using Lean, Six Sigma or PDCA methodologies.
Configure workflow automation rules, routing logic, approval matrices and escalation paths.
Report BPM maturity, process KPI improvements and savings realised to leadership quarterly.

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Layer 07

Enterprise Data & Analytics

Performance reporting, clinical/commercial/supply analytics, AI and machine learning, and enterprise data management capabilities powering data-driven decisions.

Performance Reporting

Operational KPI Reporting

Define operational KPI library with metric definitions, owners, data sources and reporting cadence.
Automate KPI data collection from source systems and load to reporting data warehouse.
Publish operational KPI dashboards with drill-down capability to cost centre and product level.
Conduct monthly operational performance reviews against targets with root cause for underperformance.
Manage KPI governance: adding, retiring and redefining metrics through change control.
Report operational KPIs to leadership with trend analysis and benchmark comparison quarterly.

Commercial Analytics

Integrate syndicated data (IQVIA, Symphony, Claims) with CRM and financial data for commercial insights.
Build prescription driver models linking HCP characteristics, touchpoints and prescribing behaviour.
Conduct market share and patient journey analysis by segment, geography and channel.
Measure promotional ROI and channel attribution using econometric and multi-touch models.
Generate next-best-action recommendations for field teams using prescriptive analytics.
Present commercial analytics insights and implications to brand teams and commercial leadership.

AI Drug Discovery

Apply generative AI and deep learning to design novel molecular structures with desired target properties.
Use structure-based and ligand-based virtual screening to prioritise compound libraries for synthesis.
Integrate AI predictions with experimental validation loops to iteratively improve compound design.
Apply AI to predict ADMET (absorption, distribution, metabolism, excretion, toxicity) properties in silico.
Build AI models for biomarker prediction, patient stratification and clinical endpoint forecasting.
Document AI model validation, uncertainty quantification and limitations for regulatory and scientific review.

Master Data Management

Define master data domains (HCP, product, site, vendor, patient) with golden record ownership.
Implement MDM platform for data ingestion, matching, merging and survivorship across sources.
Manage master data creation, modification and retirement workflows with multi-tier approval.
Cleanse and enrich master data using third-party reference data (OneKey, IQVIA data) periodically.
Publish golden record master data to consuming systems via real-time API and batch feeds.
Report MDM data quality scores, duplicate rates and domain coverage to data governance monthly.

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Layer 08

Cybersecurity & Digital Trust

Identity and access management, security operations, data protection, encryption, and secure collaboration capabilities maintaining digital trust and compliance.

Identity & Access Management

Identity Governance

Define identity lifecycle workflows: provisioning, role assignment, transfer and deprovisioning.
Maintain role-based access control (RBAC) framework with role definitions and entitlement matrices.
Automate identity provisioning via HR system integration for joiners, movers and leavers.
Enforce separation of duties (SoD) controls and detect conflicts through automated rule engines.
Manage orphan accounts and stale accounts through automated detection and remediation.
Report identity governance compliance metrics (provisioning SLA, SoD violations) to CISO monthly.

Privileged Access Management

Manage privileged accounts (admin, service, root) through a PAM solution.
Enforce just-in-time (JIT) privileged access with session recording and approval workflows.
Rotate privileged credentials automatically and store securely in an enterprise credential vault.
Monitor privileged session activity for anomalous behaviour with real-time alerting.
Audit privileged access usage and review entitlement appropriateness quarterly.
Report privileged account inventory, access events and policy violations to CISO monthly.

Threat Detection & Incident Response

Operate a SIEM platform ingesting logs from endpoints, network, cloud and application sources.
Develop and tune detection rules and use cases for known threat actor TTPs (MITRE ATT&CK).
Apply UEBA (User and Entity Behaviour Analytics) to detect insider threats and compromised accounts.
Maintain a tested incident response plan covering preparation, detection, containment and recovery.
Perform forensic evidence collection, malware analysis and root cause determination.
Conduct post-incident review; update playbooks and controls based on lessons learned.

Data Loss Prevention

Deploy DLP tools across email, endpoint and cloud channels to detect and prevent data exfiltration.
Define and tune DLP policies for sensitive data categories (PII, IP, clinical data, financial data).
Investigate DLP policy alerts and take proportionate response actions (block, quarantine, educate).
Monitor DLP incident trends and adjust policy thresholds to reduce false positives and false negatives.
Train employees on data handling policies and report DLP incidents as part of security awareness.
Report DLP incident volumes, policy violations and remediation actions to CISO monthly.

☁️

Layer 09

Enterprise Technology Platform

End user services, enterprise applications (ERP, CRM, clinical systems), cloud infrastructure, network, and compute platforms underpinning the entire digital estate.

Enterprise Applications

ERP Platform

Manage ERP platform (SAP, Oracle) covering FI, CO, MM, SD, PP, QM and HR modules.
Execute ERP release management including SAP Note application, patches and upgrades.
Govern ERP master data (materials, vendors, customers, GL accounts) through formal change control.
Monitor ERP system performance, batch job runtimes and interface health daily.
Support ERP project delivery for new module implementations, roll-outs and integrations.
Conduct annual ERP landscape roadmap review aligned to vendor releases and business needs.

CRM Platform

Manage CRM platform (Salesforce, Veeva) covering HCP profiling, call reporting and campaign management.
Govern CRM data quality through duplicate management, validation rules and data stewardship.
Deploy CRM releases including new features, workflow changes and integration updates via change management.
Configure and maintain CRM territory management, targeting and cycle plan functionality.
Train field users on CRM capabilities, mobile app use and data entry standards.
Report CRM adoption rates, data quality metrics and system performance to commercial IT leadership.

Cloud Infrastructure

Manage multi-cloud or hybrid cloud environments (Azure, AWS, GCP) with defined landing zones.
Enforce cloud security baselines, policy-as-code and continuous compliance monitoring.
Optimise cloud cost through reservation management, right-sizing and waste identification.
Manage cloud resource provisioning via Infrastructure-as-Code (Terraform, ARM, CloudFormation).
Monitor cloud service health, availability and performance against SLA thresholds daily.
Review cloud architecture and cost optimisation opportunities quarterly.

Manufacturing Systems (MES)

Manage Manufacturing Execution System (MES) for electronic batch record (EBR) execution.
Maintain MES recipe and master data aligned to approved manufacturing processes.
Integrate MES with ERP, LIMS, PI and serialisation systems for seamless data flow.
Execute MES validation and change control for all system modifications in a GMP environment.
Monitor MES system performance, batch execution errors and interface availability 24×7.
Support MES rollout to new sites or production lines through validated implementation projects.

IT Service Management

Service Desk

Provide multi-channel IT service desk (phone, chat, email, portal) with defined service hours.
Triage and categorise incidents and requests against SLA tiers (P1–P4) for routing.
Resolve Tier 1 incidents at first contact (FCR target ≥70%) using knowledge base support.
Escalate Tier 2/3 incidents to technical resolver groups with SLA tracking.
Manage service request fulfilment (software, access, hardware) against catalogued SLAs.
Report service desk KPIs (FCR, CSAT, SLA compliance, ticket volumes) to IT leadership monthly.

Backup & Recovery

Implement backup policies covering RPO/RTO requirements for all critical systems and data.
Execute scheduled backups and monitor completion success rates with alerting for failures.
Test backup restoration quarterly for critical systems to validate recoverability.
Manage offline and offsite backup copies to protect against ransomware and site disasters.
Maintain backup infrastructure (servers, agents, media) with software and hardware currency.
Report backup success rates, RTO test results and data protection coverage to IT leadership.

The Complete
Digital Capability
Map for Pharma

Nine Layers. End-to-End Coverage.

Explore Every Capability

The CompleteDigital CapabilityMap for Pharma

Nine Layers. End-to-End Coverage.

Explore Every Capability

The Complete
Digital Capability
Map for Pharma