VALIDATION
VALIDATION
The validation process is a critical step, requiring rigor and organization. Our experience of over 20 years in this domain will ensure state of the art validations. We will committed on projects planning constraints and on budgets expectations of our clients. Member of the ISPE, the SPC Group has been a major player in the Consulting and Integration of Industrial Information Systems for 30 years in a number of sectors, including the pharmaceutical industry, which accounts for nearly 40% of its business turnover.
With this positioning, the SPC Group will bring you in addition to its methodological and regulatory skills, a proven business competence and a proven knowledge of the solutions to be validated, all ensuring a successful and economical validation process.
Our methodology
Our consultants’ team is familiar with the methodology proposed by the GAMP 5 and the FDA guides. We systematically take into account Data Integrity requirements and ALCOA best practices.
Our approach is relying on 3 main principles :
- Relevant risk analyzes giving a fair assessment of the system,
- A qualification approach based heavily on good engineering practices (Acceptance tests, …)
- The establishment of appropriate processes for maintaining validated systems.
Beyond these highlights, we will of course accompany all along the different stages: Validation strategy, validation plan, risk management, preparation, execution and conclusions of qualifications, periodic review, change control and maintenance in a validated state.
Our methodology
Our consultants’ team is familiar with the methodology proposed by the GAMP 5 and the FDA guides. We systematically take into account Data Integrity requirements and ALCOA best practices.
Our approach is relying on 3 main principles :
- Relevant risk analyzes giving a fair assessment of the system,
- A qualification approach based heavily on good engineering practices (Acceptance tests, …)
- The establishment of appropriate processes for maintaining validated systems.
Beyond these highlights, we will of course accompany all along the different stages: Validation strategy, validation plan, risk management, preparation, execution and conclusions of qualifications, periodic review, change control and maintenance in a validated state.
Our skills
For 20 years, the SPC Group has been supporting its customers in validating systems in a wide variety of regulatory and industrial contexts.
Considering the number of projects we’ve carried out, we master most of the regulatory guidelines and manufacturing practices: US GxP, 21 CFR Part 11, European BPx, ICH Q7 or WHO GMP.
In addition, the skills of the SPC Group on computerized systems (ERP, LIMS, GED, EBR, QMS, MES, WMS, serialization…), on automated systems (SCADA, DCS, …), or even beyond on laboratory equipment (QC, or R & D) allow us to bring you a high level of advice to optimize their implementation in order to meet the regulatory requirements.
Our skills
For 20 years, the SPC Group has been supporting its customers in validating systems in a wide variety of regulatory and industrial contexts.
Considering the number of projects we’ve carried out, we master most of the regulatory guidelines and manufacturing practices: US GxP, 21 CFR Part 11, European BPx, ICH Q7 or WHO GMP.
In addition, the skills of the SPC Group on computerized systems (ERP, LIMS, GED, EBR, QMS, MES, WMS, serialization…), on automated systems (SCADA, DCS, …), or even beyond on laboratory equipment (QC, or R & D) allow us to bring you a high level of advice to optimize their implementation in order to meet the regulatory requirements.
Our assets
Our ambition is clearly to deliver a state of the art validation project that is optimized in terms of costs and deadlines.
By entrusting your validation process to the SPC Group, you will benefit of :
- an experienced assistance, respectful of the validation standards.
- a technical and functional knowledge of validated solutions as well as a recognized experience in the design and in the integration of automated and computerized systems providing us with the capability to deliver an optimal approach to qualification.
- a very good knowledge of the regulated industries and their regulatory requirements. This knowledge will especially benefit to address the critical management of risks.
Our assets
Our ambition is clearly to deliver a state of the art validation project that is optimized in terms of costs and deadlines.
By entrusting your validation process to the SPC Group, you will benefit of :
- an experienced assistance, respectful of the validation standards.
- a technical and functional knowledge of validated solutions as well as a recognized experience in the design and in the integration of automated and computerized systems providing us with the capability to deliver an optimal approach to qualification.
- a very good knowledge of the regulated industries and their regulatory requirements. This knowledge will especially benefit to address the critical management of risks.
