Our expertise – QCV, quality and production

With experience in the life sciences sectors, LabG consultants in accordance with their area of expertise, guide manufacturers in the evolution and compliance of all their systems (Quality, Equipment, Processes and Facilities).

Project management and engineering

LabG guides your company from the perfecting to the delivery of products in all your production, compliance and construction projects.

Our services (non-exhaustive list) :

N

Project management

  • Project management within the specified time, budget and quality framework
  • Implementation of an adequate project organization: team Management and planning, implementation of follow-up and information meetings and KPIs…
  • Verification of quality compliance documents and project profitability
N

Engineering

  • Drafting and approval of the URS, the specifications…
  • Conducting feasibility studies, design
  • Management and execution of FAT, SAT and design qualification
  • Management of technical shutdowns, maintenance and calibrations

Qualification and validation

LabG’s Commissioning, Qualification and Validation (CQV) engineers guide you and provide you with their expertise in all your qualification and validation activities of equipment, manufacturing processes, facilities and computerized systems and disposal.

Our services (non-exhaustive list) :

N

Definition of qualification and validation strategies

N

Drafting and/or updating and approval of all qualification and validation documents :

  • Validation plan
  • Risk analysis
  • Traceability matrix
  • Qualification and validation procedure
  • Protocol and report
  • Instruction for use in production following qualification and validation
N

Planning and monitoring of all qualification and validation activities and the maintenance of the validated state

N

Execution of commissioning, installation qualification, operational qualification and performance qualification, requalification and revalidation tests

N

Coordination of external service providers

N

Training of production staff to operate qualified systems and equipment

Quality assurance

Confronted with the constant evolution of regulations and the many challenges of production, LabG quality assurance experts guide you in all your quality assurance activities, from the implementation of your quality systems to the release of production batches on the market.

Our services (non-exhaustive list) :

N

Review and approval of qualification / validation and production documents

N

Implementation and improvement of the quality system

N

Evaluation of suppliers

N

Review, evaluation and approval of change requests, non-conformities and CAPA

N

Participation in audits and inspections

Production support

LabG supports your operational teams in their daily activities by freeing up time for them to focus on their core business and achieve production objectives.

Our services (non-exhaustive list) :

N

Treatment of deviations

N

Investigation of anomalies related to the batch record

N

Document update: SOP, checklist, logbook, etc.

N

Continuous improvements implementation

N

Production staff training