IB Pharmaceuticals
Pharmaceuticals
Retire legacy pharma systems. Keep clinical, quality, and manufacturing records inspection-ready
Archive clinical trial, research, manufacturing, and quality data to shut down aging systems, reduce IT and cyber risk, and keep fast, controlled access to historical records for audits, inspections, and product lifecycle questions.
The Challenge
Pharma companies must keep records for decades, long after the systems that created them are obsolete
- Legacy SAP, ERP, and quality systems retained only to answer future audit questions
- Long retention periods for clinical, manufacturing, and quality records
- Data spread across R&D, manufacturing, quality, and regulatory systems, often inherited through mergers, divestitures, and site closures
- Unsupported applications holding sensitive research and product data
A pharmaceutical product’s records can matter for many years after launch, and sometimes after the product itself is discontinued. Trial data may be needed for follow-up questions and regulatory submissions. Batch and quality records may be needed to support investigations, complaints, or inspections. Meanwhile, every older system that holds this information adds hardware, licensing, validation overhead, and security exposure. Retiring those systems is hard to justify unless the records they hold stay accessible and controlled.
Solutions
Archive pharma data and retire legacy applications
- Extract clinical, R&D, manufacturing, and quality data from legacy systems with relationships and context preserved
- Retire legacy SAP and ERP applications, including older SAP versions, while keeping historical data accessible
- Search archived records quickly, including through natural language with AQL Copilot™, without keeping the source application running
- Deploy on-premises, in the cloud, or in a hybrid model, including support for SAP ECC and S/4HANA environments
Infobelt Omni Archive Manager (OAM™) is a unified platform that archives, verifies, compresses, encrypts, indexes, and extracts structured, semi-structured, and unstructured data. For SAP landscapes, Infobelt Essentials for SAP is certified by SAP for integration with SAP S/4HANA and supports archiving from SAP ECC and S/4HANA, on-premises or in the cloud. Archived content stays searchable by your teams, without depending on the original system.
Use Cases
Preserving the research and production record without running legacy systems
- Archive clinical trial data and supporting documents after study close-out or system consolidation
- Preserve research and development data, including laboratory and study records, after platform retirement
- Retire legacy manufacturing execution, ERP, and SAP systems at closed or divested sites while keeping batch and production history
- Retain quality records such as deviations, change controls, CAPAs, and complaint files for audits and inspections
- Consolidate data from acquired companies and divested product lines
- Support SAP ECC to S/4HANA transitions by archiving historical data and keeping it accessible
Benefits
Lower cost, faster audit response, reduced operational risk
- Reduce infrastructure, licensing, and maintenance costs from legacy systems
- Find and produce historical records faster during audits and inspections
- Shrink the footprint of unsupported or hard-to-patch applications
- Simplify site consolidation, divestitures, and ERP modernization programs
Quality, regulatory, IT, and manufacturing teams gain a single place to find historical records, rather than a patchwork of legacy applications and offline media.
Compliance & Risk Mitigation
Strengthen records governance while reducing data and cyber risk
- Apply retention schedules and legal holds to clinical, manufacturing, and quality records using OAM's built-in policy manager
- Maintain activity audit trails and access transparency across archived records
- Support defensible disposition of records once retention periods have ended
- Use immutable (WORM-capable) storage, archive encryption, and fine-grained entitlements to protect archived data
- Reduce ransomware exposure with isolated, immutable archives
Pharmaceutical records programs are commonly shaped by requirements such as FDA 21 CFR Part 11, GxP expectations, EU Annex 11, ICH GCP, and data privacy laws such as GDPR and HIPAA. OAM provides retention, audit trail, immutability, and disposition capabilities that support these programs. How they apply to a given system or record is a determination for your quality, regulatory, and legal teams, and any validation activities remain your responsibility.
Why Infobelt Omni Archive Manager (OAM™) for Pharmaceuticals
OAM brings archiving, records management, and retrieval into a single platform instead of a collection of separate tools.
- Acquire: Ingest data from databases, file systems, ERP systems, SaaS platforms, email, websites, and flat files using pre-built connectors
- Manage: Scale from megabytes to multi-petabytes, with OmniBot™ automation for archive management
- Access: Query archives with AQL Copilot™ and use full-text, keyword, and semantic search for e-discovery and analytics
- Govern: Retention policies, legal holds, audit trails, and defensible disposition in one platform
- SAP-ready: Infobelt Essentials for SAP supports SAP ECC and S/4HANA, including ArchiveLink and CMIS connectivity, and is aligned with RISE with SAP deployments
- Deploy: On-premises, cloud, or hybrid
OAM is proven at enterprise scale. Infobelt manages more than 30 trillion records for a Fortune 10 bank, with data drawn from over 550 legacy applications and data sources. Read the case study
Frequently Asked Questions
What is pharmaceutical data archiving?
Pharmaceutical data archiving moves clinical, research, manufacturing, and quality records out of active systems into a secure, searchable archive governed by retention rules. It keeps records accessible for audits and inspections while allowing legacy systems to be retired.
Can a legacy SAP or ERP system be retired without losing access to batch and quality history?
Yes. Application retirement extracts the data and its relationships into the archive, where it remains searchable and reportable, so the legacy SAP or ERP environment can be decommissioned.
Does OAM support SAP ECC and S/4HANA?
Infobelt Essentials for SAP supports SAP ECC and SAP S/4HANA across on-premises, cloud, and hybrid deployments, and is certified by SAP for integration with S/4HANA.
How does archiving help with audit and inspection readiness?
Archived records are indexed and searchable, with audit trails showing access activity. Teams can locate and retrieve historical records without restoring or operating the original system.
Does OAM guarantee regulatory compliance?
No archive platform can guarantee compliance on its own. OAM provides retention policies, legal holds, immutability, audit trails, and defensible disposition to support your compliance program, which your quality, regulatory, and legal teams define and validate.
Retire legacy pharma systems without losing the records you must keep
Talk with our team about archiving your clinical, research, manufacturing, and quality data and reducing the cost and risk of aging systems.