Lifecycle Validation Framework

Validation & Qualification Overview

Procure | Install | Qualify | Validate | Maintain

  • Ensures systems, equipment, and processes perform as intended across their lifecycle
  • Covers GLP, GMP, GCP, and CSV compliance requirements
  • Delivers reliable, accurate, and reproducible results
  • Aligned with ICH, EU GMP Annex 15, and FDA standards
  • Ensures data integrity and inspection readiness

Guided by Experts

Guided by Experts

  • Led by experienced validation experts across GMP, GLP, GCP, and CSV frameworks
  • End-to-end lifecycle support for equipment, systems, and processes
  • Risk-based, science-driven validation approach
  • Ensures regulatory compliance, data integrity, and inspection readiness
  • Strengthens system reliability and regulatory confidence
Abstract scientific / pharma visual – molecules or lab precision

Our Expertise

Clarity, compliance, and control through expert audits.

KNOW MORE +

Validation & Qualification We Support

Validated instruments. Compliant digital systems.

HPLC Systems

GC Systems

Dissolution Apparatus

Stability Chambers

Autoclaves

Incubators

Balances

Environmental Monitoring Systems

Microbiology Equipment

Computerised Systems

A Process Built for Precision

Built for accuracy. Proven in compliance.

1

Procurement Support

Select instruments aligned with laboratory needs, ISO 9001:2015, and MHRA Annex 15 requirements.

2

Professional Installation

Ensure proper setup, environmental conditions, and operational readiness for all instruments.

3

Qualification (IQ/OQ/PQ)

  • Installation Qualification (IQ): Verify correct installation, documentation, and system readiness.
  • Operational Qualification (OQ): Confirm equipment performs within manufacturer specifications.
  • Performance Qualification (PQ): Demonstrate consistent, accurate performance under real operational conditions.
4

Calibration

Schedule and perform regular calibration, maintain traceability, and provide supporting certificates.

5

Preventive Maintenance & Servicing

Implement maintenance programs to minimize downtime, maintain validation, and ensure long-term operational efficiency

6

Documentation & Audit Readiness

Deliver complete documentation packages, including validation reports, calibration certificates, and maintenance logs, fully compliant with ISO 9001:2015 and Annex 15Readiness

Analytical Equipment Specialists

Deep technical expertise across all major analytical instruments from chromatography systems to spectroscopy, dissolution testing, and precision balances. We know your equipment inside and out.

Regulatory Compliance Built-In

Every service we provide is designed to meet ISO 9001:2015 and MHRA Annex 15 requirements. Your equipment documentation will stand up to any audit or regulatory inspection.

Full-service QC instrument compliance

Installation, IQ/OQ/PQ, calibration, maintenance planning, repair coordination, documentation packs, training, and asset management

Why Choose
Sciom

Engineered for Precision. Proven in Audits.