Company News & Updates

PHARPRO June 2026 Update: DVS-PQR Module Launched, GAMP 5 Validation Projects Completed & Thermal Mapping Expands to Pakistan

6 min read By Mohammad Awawdeh

June 2026 included full-lifecycle validation work aligned with ISPE GAMP 5 Second Edition and EU GMP Annex 11, plus the launch of the AI-assisted DVS-PQR Module for controlled Product Quality Review workflows.

Below is a summary of PHARPRO's key activities and achievements this month — directly relevant to any pharmaceutical manufacturer, distributor, or contract organisation looking to strengthen their validation, quality, and training programmes.

New
AI-assisted DVS-PQR workflow launched
12+
Pharmaceutical clients served this month
7+
Countries with active PHARPRO engagements
100%
GAMP 5 & EU GMP Annex 11 aligned deliverables

1. Utility & Software Validation Project Completed — GAMP 5, C&Q & EU GMP Annex 11

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Full-Lifecycle Validation: Protocols, Training & Consulting Delivered

PHARPRO has successfully completed a comprehensive validation engagement for one of its valued pharmaceutical clients — covering the complete lifecycle from Validation Master Plan (VMP) through to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for both utility systems and computerized systems.

All protocols were developed and executed in strict alignment with the latest ISPE GAMP 5 Second Edition risk-based methodology, Commissioning & Qualification (C&Q) best practices, and EU GMP Annex 11 requirements for computerized systems — ensuring fully inspection-ready, audit-defensible documentation.

The engagement included on-site consulting support, team training on the GAMP 5 three-category risk model, and formal documentation sign-off aligned to the client's Quality Management System (QMS).

GAMP 5 Second Edition IQ / OQ / PQ EU GMP Annex 11 C&Q Utility Validation

Why this matters: Utility and software validation gaps are among the top findings in FDA and EU GMP inspections. A completed, GAMP 5-aligned validation package — with traceable IQ/OQ/PQ protocols, risk assessments, and training records — gives your team a defensible compliance position before any regulatory visit.

Need to validate a new system or close outstanding gaps in your CSV programme? Explore our CSV Validation services or request a free validation assessment.

2. Thermal Mapping Qualification Training Initiated in Pakistan

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PHARPRO Expands Thermal Mapping Services to Pakistan

PHARPRO has initiated a Thermal Mapping Qualification training programme for a pharmaceutical client in Pakistan — marking another international milestone for PHARPRO's growing global footprint. The engagement encompasses hands-on training in temperature distribution study (TDS) methodology, sensor placement strategy, data logger qualification, and GMP-compliant documentation.

In addition to training delivery, PHARPRO provided specialist consultation on thermal mapping equipment and instrumentation — supporting the client in selecting appropriately qualified data loggers and calibrated temperature sensors compliant with WHO Technical Report Series (TRS), ASHRAE, and EU GMP Annex 1 & GDP requirements for controlled storage environments.

The training covers warehouses, cold rooms, refrigerators, freezers, and distribution vehicles — equipping the client's internal team to execute and document thermal mapping studies independently going forward.

Thermal Mapping WHO TRS ASHRAE Pakistan GDP / Cold Chain

International reach: PHARPRO now serves regulated pharmaceutical clients across Jordan, UAE, Saudi Arabia, Egypt, Pakistan, and internationally. Both remote and on-site training delivery are available — designed to build lasting in-house capability, not dependency.

Running cold storage operations that need thermal qualification? See our CQV & Thermal Mapping services or browse our GMP Training programmes to register interest for the next thermal mapping course.

3. PHARPRO DVS-PQR Module Launched for Controlled Product Quality Reviews

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New: PHARPRO DVS-PQR — Full Product Quality Review Lifecycle with Native AI

PHARPRO has officially launched the DVS-PQR Module — a dedicated Product Quality Review (PQR) software solution integrated natively within the PHARPRO DVS platform. This is the most significant DVS feature release to date, and directly addresses one of the most time-consuming recurring compliance obligations in pharmaceutical manufacturing.

The DVS-PQR Module supports annual review planning, data collection, trend analysis, batch summaries, deviation and CAPA linkage, stability review and final report workflows. Electronic-record controls must be evaluated and validated for each intended use.

The integrated AI function assists with narrative drafts, trend signals and out-of-trend flags for qualified-user review. Time savings depend on data quality, product complexity and the baseline process and should be measured during a controlled pilot.

Product Quality Review Native AI FDA 21 CFR Part 11 EU GMP Chapter 1 PHARPRO DVS

See PHARPRO DVS-PQR in Action

Book a 30-minute workflow evaluation covering audit-trail records, electronic-signature controls and AI-assisted narrative drafting.

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Business case: Measure current PQR preparation, review and rework time, then compare the same products after a controlled pilot. Use observed results—not a generic savings claim—to approve the investment.

4. Project Record Verified Through August 2026

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12 Completed Engagements and 2 Active Projects

PHARPRO's founder-led record now documents 12 completed consulting and training engagements and two active projects as of August 2026. The record separates PHARPRO delivery from Mohammad Awawdeh's earlier employment experience.

The documented scope includes:

  • Computerized System Validation (CSV) — LIMS, ERP, and laboratory instrument validation aligned with GAMP 5 and 21 CFR Part 11
  • QA Gap Assessments — Pre-inspection readiness reviews for upcoming FDA and EU GMP authority visits
  • GMP Training Delivery — Data integrity, CAPA management, and compressed air testing training programmes
  • Thermal Mapping & CQV — Cold room and warehouse qualification studies across Jordan, UAE, and Pakistan
  • PHARPRO DVS Release — Public release of the founder-built digital validation platform in April 2026
  • Facility Design & Tender Management — Conceptual design, tender management, and pharmaceutical facility project support in the UAE

Project planning: If your organisation has validation, qualification, or compliance work planned for Q3 or Q4 2026, begin scoping early so timelines, deliverables, and resource needs can be agreed.

Work With PHARPRO — Start With a Free Compliance Assessment

Whether you are preparing for an inspection, validating a new system, establishing a facility or strengthening your quality programme, PHARPRO offers accountable, founder-led technical delivery.

Review the dated project record before deciding whether the experience and scope are relevant to your organisation.

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PHARPRO News DVS-PQR Module GAMP 5 EU GMP Annex 11 Thermal Mapping Pakistan Product Quality Review CSV Validation GMP Training June 2026

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