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Pharma Document Management System in 2026: GMP Document Control and Inspection Readiness

Learn how pharmaceutical teams can strengthen document control, manage electronic records, support data integrity, and prepare for inspections. This guide explains key system controls, audit expectations, and practical checks for a more reliable GMP documentation process.
  • Blog, Computerized System Validation
Pharmaceutical quality professional using an electronic system for controlled records, audit trail review, and data integrity oversight

Novocure Devices Stayed Secure; 1,400+ U.S. Patient Records Put Digital Quality Under Scrutiny

Novocure reported that unauthorized access to certain information systems in mid-August exposed records linked to more than 1,400 U.S. patients. The company confirmed that its medical treatment devices were not accessed and all systems remain operational. Nevertheless, the incident highlights
  • News
Novocure Devices Stayed Secure; 1,400+ U.S. Patient Records Put Digital Quality Under Scrutiny

Pharma Data Science in 2026: Applications, AI, and GMP Compliance

Explore how data science in pharma supports AI, machine learning, manufacturing analytics, and GMP decisions. Learn where data quality, validation, human oversight, and inspection readiness matter most across the pharmaceutical lifecycle, from development to post-market safety.
  • Blog, Computerized System Validation
Pharma 4.0 environment with pharmaceutical analysts reviewing data dashboards beside a modern manufacturing line.

FDA and Duke Advance QMIN; Quantitative Medicine Gains Regulatory Momentum

The FDA and Duke-Margolis Institute for Health Policy convened a virtual summit on September 1 to help shape the Quantitative Medicine Innovation Network (QMIN). The planned cross-sector network would connect regulators, industry, academia, healthcare providers and patient groups to advance
  • News
FDA and Duke Advance QMIN; Quantitative Medicine Gains Regulatory Momentum

3 Deaths Pause 8 Novartis CAR-T Trials; Safety Review Now Expands

Novartis paused eight clinical trials of an experimental CAR-T therapy for autoimmune and neurological disorders in late August after 3 patient deaths linked to a severe immune response. The Swiss drugmaker is reviewing the safety events with independent safety boards
  • News
3 Deaths Pause 8 Novartis CAR-T Trials; Safety Review Now Expands

Cipla Licence Cancellation Withdrawn; Bombay HC Challenges Maharashtra FDA Procedure

The Maharashtra Food and Drugs Administration has withdrawn its cancellation of drug sale licences for Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility in Wadki, Pune, after the Bombay High Court criticised the procedure behind the action. The
  • News
Cipla Licence Cancellation Withdrawn; Bombay HC Challenges Maharashtra FDA Procedure

Best LabWare LIMS Alternatives in 2026: Features, Pricing, Validation, and Pharma Compliance Compared

Compare leading LIMS platforms for regulated pharmaceutical laboratories and see how they differ in validation, compliance, audit trails, deployment, and workflow control. This guide helps quality and laboratory teams choose a system that better fits operational and regulatory needs.
  • Blog, Computerized System Validation
Pharmaceutical laboratory using LIMS software with data integrity, audit trail, and GxP compliance controls.

Baxter Saline Recall Flags Fiberglass Risk; Particulate Controls Face New Scrutiny

Baxter International has voluntarily recalled two lots of 0.9% Sodium Chloride Injection in the United States because of the potential presence of fiberglass particulate matter. The FDA published Baxter’s announcement on August 26, 2026. The affected 500 mL VIAFLEX products
  • News
Baxter Saline Recall Flags Fiberglass Risk; Particulate Controls Face New Scrutiny

Apitegromab Met Its Trial Goal; Manufacturing Issues Forced Scholar Rock’s EU Reset

Scholar Rock has withdrawn its European application for apitegromab, its experimental spinal muscular atrophy treatment, and plans to resubmit using a different manufacturing site. The decision follows manufacturing compliance, fill-finish facility, and regulatory path issues at the Bloomington, Indiana site
  • News
Apitegromab Met Its Trial Goal; Manufacturing Issues Forced Scholar Rock’s EU Reset

No Quality Defect, Yet EU Supply Is Disrupted: EMA Flags Paliperidone Shortage

The European Medicines Agency has reported a shortage of long-acting injectable paliperidone palmitate medicines in some EU member states after manufacturing problems at Greek contract manufacturer Pharmathen International disrupted supply. The affected medicines treat adults with schizophrenia whose condition has
  • News
No Quality Defect, Yet EU Supply Is Disrupted: EMA Flags Paliperidone Shortage