Validation
C&M Scientific understand the need to validate.
C&M Scientific can support all aspects of validation including:
URS [User Requirement Specification] compilation, with template examples available.
Design Qualification. regulatory bodies expect to find a DQ where the supply is bespoke. Constructing a useful and meaningful DQ can be highly productive when taking on large multifaceted systems, particularly where customisation or bespoke software is included.
Installation Qualification. The starting block for many Validation Projects. This is often as far as some companies get. A good IQ can cover many aspects of the validation process. C&M Scientific can offer advise on the scope of such documentation. We have a small library of protocols available as examples.
Operational Qualification. Most companies should achieve this level of validation. C&M Scientific have a considerable experience in executing OQ. From the simple temperature control to complex analytical equipment, establish and executing high quality OQ is a strong element of C&M Scientifics capability.
Performance Qualification. Perhaps the most meaningful element of validation. Testing the equipment in a dynamic state with the plan use of load configurations provides the most valued data in supporting a regulated process. In conjunction with the client C&M Scientific can construct high quality documentation and the execution of PQ.
By using C&M Scientific's Validation Team you can:
Reduce commitment to fulltime employment overhead.
Access experience staff from day one of a project.
Have costings available on hourly, daily, or project basis.
C&M Scientific can provide experienced support in the following areas of operation
Help establish a Quality system.
Provide a review of current validation status.
Support a total site validation exercise.
Support a project specific validation exercise.
Supplement existing validation resources, or provide an entire validation team.
Provide expert on site support during audit or client inspections.
C&M Scientific have over 25 years experience :
Validating equipment for Biotechnology ,Pharmaceuticals and Hospital Laboratories
Validating electronic data systems, including spreadsheets and databases.
Metrology systems for GLP & cGMp
C&M Scientific can provide qualification protocols for a wide range of instruments to IQ ,OQ and PQ level.
Key features of the services and protocols include:
Manufacturer and model specific protocols that can be tailored to include individual needs
Document control analogous to industry and contract laboratory GMP regulations
Pre-Approval section for protocol to be completed prior to execution
Performer/Reviewer credentials and signature on each page,
Identification of the equipment to be qualified
A listing of traceable materials required to complete qualification to provide fully traceable results
The detailed procedure of how the qualification is completed,
Final Approval section to be completed following execution
The contact for validation services in C&M SCIENTIFIC LTD is: Alistair Bamford
Validation is an extremely diverse and complex area of regulatory concern, impacting all areas of pharmaceutical and medical device manufacturing, biological research and clinical testing.
Validation has become one of the most important areas of regulatory compliance for the science laboratory, particularly in the pharmaceutical industry and international regulatory agencies, led by the United States Food and Drug Administration, (FDA) now require laboratories to show validation for both methods and analytical equipment.
Within the validation programme lies the whole area of qualification testing which is carried out at predefined intervals and sets out to show that the equipment has been installed and operates or performs to the manufacturer's requirements or specifications and is suitable for its intended use.
The following somewhat simplistic schematic of the qualification programme shows the relationship between the stages of qualification testing and validated use. 