Power faster drug development with high-quality, trusted data
Regulatory compliance & audit readiness
Regulatory frameworks like FDA 21 CFR Part 11, EMA Annex 11, and GxP require accurate, auditable data across drug development and manufacturing. Poor data integrity can lead to failed audits, compliance violations, and product recalls.
Ataccama’s benefits
-
Centralized compliance data
Unify regulatory data across clinical trials, manufacturing, and supply chain for consistent reporting.
-
Audit-ready reporting
Maintain full data lineage and traceability to meet regulatory inspection requirements.
-
Automated data validation
Ensure accuracy and completeness of compliance data with built-in validation rules.
-
Reduced regulatory risk
Prevent costly fines and operational disruptions with reliable, high-quality data.
Clinical trial data integrity
Clinical trials depend on accurate, high-quality patient and trial data to support regulatory approvals. Data inconsistencies can result in delays, rejected submissions, and safety risks, jeopardizing drug approvals and market entry.
Ataccama’s benefits
-
Trusted trial data
Ensure accuracy and completeness in patient records, trial results, and adverse event reporting.
-
Real-time data quality monitoring
Detect inconsistencies in clinical trial data before submission to regulators.
-
Automated data cleansing
Eliminate duplicate records and incorrect patient identifiers across trial sites.
-
Regulatory submission support
Maintain structured, validated datasets for streamlined drug approval processes.
Supply chain visibility & traceability
Strict regulations like DSCSA and EU FMD require full traceability of pharmaceutical products. Poor supply chain data can lead to counterfeiting risks, compliance violations, and disruptions in drug availability.
Ataccama’s benefits
-
End-to-end supply chain data visibility
Track product movement from raw materials to final distribution.
-
Counterfeit prevention
Ensure data accuracy for serialization and track-and-trace programs.
-
Compliance-ready reporting
Maintain high-quality, auditable supply chain data for regulatory bodies.
-
Real-time anomaly detection
Flag discrepancies in supplier, inventory, and shipment records before they impact production.
New core systems & migrations
Migrating legacy systems without clean, structured data can cause compliance risks and delays in drug approvals. Pharmaceutical companies must ensure data integrity when moving to modern ERP, LIMS, or regulatory reporting platforms.
Ataccama’s benefits
-
Seamless data migration
Cleanse and standardize data before moving to new core systems.
-
Regulatory compliance
Maintain data integrity to meet FDA, EMA, and GxP requirements during migration.
-
Reduced operational risks
Prevent errors and inconsistencies in patient records, clinical trials, and supply chain data.
-
Accelerated deployment
Ensure faster, smoother system migrations with validated, high-quality data.
AI readiness
AI-driven drug discovery, clinical trials, and predictive analytics rely on high-quality, structured data. Poor data integrity can lead to unreliable AI models, failed predictions, and compliance issues in pharmaceutical research.
Ataccama’s benefits
-
Trusted AI datasets
Provide high-quality, unbiased data for AI-driven drug discovery and trial analysis.
-
Real-time data monitoring
Ensure AI models use clean, validated data for accurate predictions.
-
Bias-free analytics
Eliminate inconsistencies that could compromise regulatory submissions and market readiness.
-
Faster drug development
Enable AI-powered insights with complete, high-quality datasets.
Operational reporting
Pharmaceutical companies depend on accurate reporting for compliance, clinical trials, and supply chain management. Poor data quality leads to regulatory fines, misinformed decisions, and audit failures.
Ataccama’s benefits
-
Regulatory-ready reporting
Generate accurate, auditable reports for FDA, EMA, and global regulators.
-
Cross-functional data consistency
Unify data across R&D, manufacturing, and distribution teams.
-
Automated data validation
Eliminate errors in reporting with built-in data quality checks.
-
Improved decision-making
Ensure reliable insights for drug development and market forecasting.
Process automation
Manual data handling in clinical trials, regulatory submissions, and supply chain tracking increases the risk of errors, inefficiencies, and compliance violations. Automating data processes ensures accuracy and consistency across operations.
Ataccama’s benefits
-
Automated compliance workflows
Streamline data validation for regulatory reporting and audits.
-
Faster clinical trial data processing
Reduce delays by eliminating manual data reconciliation.
-
Reduced operational risks
Minimize errors in patient records, drug approvals, and inventory tracking.
-
Cost savings & efficiency
Free up resources by automating high-volume data processing tasks.
M&A integrations
Pharmaceutical mergers and acquisitions require seamless data integration across clinical, regulatory, and commercial systems. Inconsistent or siloed data causes delays in operational alignment, compliance risks, and reporting challenges.
Ataccama’s benefits
-
Standardized data consolidation
Unify patient, trial, and supply chain data across merged entities.
-
Faster post-merger integration
Accelerate system consolidation with automated data mapping and cleansing.
-
Regulatory alignment
Maintain compliance by ensuring consistent data across acquired business units.
-
Business continuity
Prevent disruptions by ensuring clean, consolidated data across all platforms.