Validation, compliance and qualification across the entire life cycle

Validation documentation is the common thread linking requirements, risk analysis, verification activities and regulatory compliance throughout the entire life cycle of systems, plants and processes.

We support our clients in drafting, reviewing and managing the documentation needed to demonstrate that every solution is designed, built and verified according to defined, traceable criteria consistent with the applicable requirements.

Clear, complete and well-structured documentation makes collaboration between manufacturers, end users and quality functions easier, reducing project times, misunderstandings and the risk of non-compliance.

Validation covers everything that could pose a hazard to those who will use the medicine. For this reason, every part of the system that affects the quality and safety of the product must be described in detail.

• Definition of requirements and validation strategies
• Management of traceability between requirements, risks, verifications and documentary evidence
• Drafting of validation and GMP qualification documentation (URS, FDS, RA, VP, DQ, IQ, OQ, PQ and related documents)
• Updating and adapting the documentation when the system is modified, extended or evolves over its life cycle

GMP compliance is not just about applying regulatory requirements: it requires an in-depth knowledge of the processes, risks and responsibilities that affect product quality.

We support pharmaceutical companies, medical device manufacturers, machine and plant builders and technology suppliers in interpreting and applying regulatory requirements, helping Quality functions with the activities needed to maintain and demonstrate compliance.

The experience we have gained in production and validation settings allows us to combine regulatory aspects with the operational needs of the project, helping to reduce critical issues, deviations and risks throughout the life cycle of systems and processes.

• Support for Quality Assurance and Quality Control functions
• Risk management applied to processes, systems and organisations
• Gap analysis against GMP requirements and company procedures
• Definition and updating of procedures, methodologies and quality systems

Commissioning and qualification mark the transition from design to objective evidence of system performance.

We support manufacturers, integrators and end users in the verification, testing and qualification of machines, plants, software, environments and utilities, making sure that what has been built is installed correctly, works according to the defined requirements and is fit for its intended use.

The experience we have gained in production and regulated settings allows us to work both at the supplier’s site and at the client’s final site, collaborating with project teams throughout all verification and commissioning phases.

• Planning and execution of commissioning activities
• Support for Design Qualification (DQ)
• Verification of correct installation and configuration of systems
• Verification of functionality and performance against defined requirements (PQ)
• Execution of Installation Qualification (IQ) and Operational Qualification (OQ) activities
• Support for testing and on-site qualification