COMMISSIONING AND VALIDATION

Cx is critical because it underpins compliance and product quality. Cx proves systems perform to design; validation demonstrates they meet FDA/GMP expectations for consistent, controlled results - reducing batch risk, deviations, and startup delays. Hallam-ICS Cx & V experts map commissioning outputs directly into qualification to streamline compliance.

Commissioning is a quality-focused process that verifies and documents that systems are planned, designed, installed, tested, operated, and maintained to meet the Owner’s Project Requirements (OPR). Validation (in regulated industries) adds documented evidence - often via IQ/OQ/PQ - that equipment and processes consistently perform as intended. Our Commissioning & Validation team delivers both under one coordinated methodology.

• IQ verifies proper installation against approved design/manufacturer specs.
• OQ verifies the system operates as intended across defined ranges.
• PQ confirms the process performs consistently in real-world conditions.
  Hallam-ICS Cx & V experts author and execute risk-based IQ/OQ/PQ (and DQ where required) aligned to your SOPs and regulators’ expectations.

Yes. Our methodology aligns with ANSI/ASHRAE Guideline 0 / Standard 202 for commissioning and with industry guidance for validation (ISPE concepts, GAMP-style documentation) to ensure traceability from user requirements to testing and maintenance. 

We coordinate with QA/IT to address user requirements, access control, audit trails, backup/restore, and 21 CFR Part 11-style expectations. Validation evidence (e.g., OQ of alarms, reports, and security) is incorporated into the final package for inspection readiness. 

Expect a complete, audit-ready package: OPR/BOD traceability, design review records, pre-functional/functional tests, deficiency logs, training agendas, SOP inputs, and validation documents (V-plan, risk assessments, approved IQ/OQ/PQ protocols and reports). Our Commissioning & Validation team structures documentation for regulators and operations. 

Yes. When planned early, commissioning checklists and functional tests become evidence for qualification, minimizing duplicate testing and compressing schedules. Our Cx & V experts use a V-Model approach to connect design specs to executed tests and qualification. 

Life sciences (biotech, pharma, medical devices), semiconductor/advanced manufacturing, food & beverage, and other regulated industrial facilities. Our Cx & V experts adapt protocols to your process hazards, cleanliness/classification, and regulatory profile.

Absolutely. Services include temperature/ RH mapping of warehouses and controlled environments, HEPA/airflow verification, pressure cascade checks, and data integrity for reports—executed and reported by our Commissioning & Validation team.

Scope typically covers OPR/BOD alignment, design reviews, submittal checks, construction checklists, functional performance testing, training, and turnover documentation—plus validation planning, IQ/OQ/PQ protocol development/execution, and summary reports. Our Commissioning & Validation team manages the entire arc from pre-design through operational readiness.