Regulatory Archival, Clinical Data Management & GxP Compliance Solutions
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Pharmaceutical companies regularly undertake ERP and Laboratory Information Management System modernisation programmes yet are compelled to retain legacy platforms in operation because of ongoing requirements to access historical batch records, quality data, and financial postings under GxP and regulatory frameworks.
SMARCK archives ERP transactional data, LIMS batch records, laboratory results, quality event records, and associated documentation in a validated, compliant repository -enabling full decommissioning of legacy systems without compromising data accessibility or regulatory standing.
Legacy platforms are retired on schedule, eliminating dual-system maintenance and licensing costs. Quality, regulatory affairs, and finance teams retain immediate access to all historical records, and the archived data meets GxP validation requirements for use in regulatory submissions and inspections.
Pharmaceutical manufacturers are subject to stringent GxP data retention obligations under FDA 21 CFR Part 11, EU Annex 11, ICH Q10, and equivalent frameworks - requiring that electronic records and audit trails are retained in a validated, secure state for defined periods, often exceeding the product lifecycle.
SMARCK provides a validated electronic archival platform with immutable storage, full audit trail preservation, role-based access controls, and electronic signature support - purpose-built to meet GxP data integrity requirements across regulated pharmaceutical environments.
Regulatory inspections and data integrity audits are navigated with confidence. Complete, unmodified records are available on demand with full audit trail traceability, and the risk of data integrity findings or regulatory action due to inadequate record retention is substantially mitigated.
Sponsors and contract research organisations are required to archive clinical trial master files, patient data, investigator records, and regulatory submissions for periods of up to 25 years post-trial. Managing this obligation across multiple studies, sites, and systems is operationally complex and costly.
SMARCK provides structured archival of electronic Trial Master Files, patient-level data, site files, and regulatory correspondence -with metadata-driven search, role-based access for sponsor and investigator personnel, and retention schedules aligned to ICH E6 and applicable regulations.
eTMF and clinical data archival obligations are met efficiently and cost-effectively. Regulatory agencies and inspection teams can access complete trial records rapidly, and sponsors demonstrate robust data stewardship throughout and beyond the study lifecycle - supporting regulatory submissions and lifecycle management activities.
Pharmacovigilance teams manage large volumes of individual case safety reports, aggregate safety data, risk management plans, and regulatory correspondence that must be retained and remain accessible for extended periods following product approval or withdrawal.
Pharmacovigilance teams manage large volumes of individual case safety reports, aggregate safety data, risk management plans, and regulatory correspondence that must be retained and remain accessible for extended periods following product approval or withdrawal.
SMARCK archives pharmacovigilance records -including ICSRs, PSURs, RMPs, and safety correspondence -with immutable storage, structured metadata, and access controls aligned to safety team roles and regulatory obligations.
SMARCK archives pharmacovigilance records -including ICSRs, PSURs, RMPs, and safety correspondence -with immutable storage, structured metadata, and access controls aligned to safety team roles and regulatory obligations.
Safety data is preserved with complete integrity throughout its required retention period. Regulatory submissions, inspections, and signal management activities are supported by rapid, structured access to complete safety histories, and pharmacovigilance teams demonstrate full compliance with global safety reporting obligations.
Safety data is preserved with complete integrity throughout its required retention period. Regulatory submissions, inspections, and signal management activities are supported by rapid, structured access to complete safety histories, and pharmacovigilance teams demonstrate full compliance with global safety reporting obligations.
Pharmaceutical manufacturers generate extensive batch production records, deviation reports, change control documentation, and validation records that must be retained in an accurate, accessible state for the duration of the product lifecycle and beyond. Retaining these records in active manufacturing systems imposes significant storage and performance burdens.
SMARCK archives batch records, manufacturing deviations, validation documentation, SOPs, and change control records with tamper-evident storage, version control, and metadata search -enabling rapid retrieval for batch release, investigations, and regulatory submissions.
Batch record retrieval for product investigations, customer complaints, and regulatory inspections is completed in minutes rather than hours. Manufacturing systems are relieved of historical data burdens, and quality teams maintain confidence in the completeness and integrity of archived documentation.
Pharmaceutical mergers, acquisitions, and product divestitures generate complex data management obligations -requiring the secure transfer, segregation, or long-term retention of clinical, regulatory, manufacturing, and commercial records from acquired or divested entities.
SMARCK provides a structured, secure archival environment for data associated with M&A and divestiture transactions -enabling clean data segregation, controlled access by transaction parties, and compliant long-term retention of records that must be preserved beyond the transaction.
Data management obligations arising from corporate transactions are fulfilled efficiently, reducing legal and regulatory risk. Acquiring entities gain structured access to inherited data assets, and divested products retain compliant record archives without ongoing dependency on the divesting organisation's systems.