21 CFR Part 11

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21 CFR Part 11 Fulfill FDA Regulation 21 CFR Part 11 using measuring instruments and software from Testo

FDA The American Food and Drug Administration regulatory authority is responsible for monitoring production processes in the food, chemical and pharmaceutical industry. Also companies which export to the US are monitored by the FDA and are subject to their regulations.

CFR The Code of Federal Regulations, as a body of rules and regulations, is obligatory for the industries involved. The code is divided into separate titles which are mostly drafted according to result so that it is left up to the company to select the most suitable method.

The body of rules and regulations of the FDA describes applications out of the food, pharmaceutical, health etc. industries in over 1,400 parts.

21CFR Part11 Part 11, which came into effect in 1997, deals with electronic records and signatures. They are equated with manual documents and signatures when Title 21 CFR Part 11 is adhered to.

GMP The EU Good Manufacturing Practice handbook is a standard volume which regulates the manufacture and import of pharmaceutical products for use in the EU.

SOP Standard Operating Procedures provide directions for people manufacturing pharmaceutical and food products. They serve to minimise application errors and for liability purposes. They are adapted specifically to a company`s needs and connect the performance of the measurement technology with the environment of the process when data loggers are used.

Testo has specifically adapted the operating concept of ComSoft 3.3 in conjunction with Testo data loggers such that the number of possible human errors and also the range of SOPs necessary are reduced. Safety risks specific to applications are, of course, still covered by appropriate directions.

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21 CFR Part 11

Validation The manufacturers of FDA regulated products, in particular pharmaceutical and chemical products as well as foodstuffs are subject to strict validation of their processes. The American regulatory authority Food & Drug Administration stipulates uninterrupted documentation and long-term filing of process variables. Authority regulations in relation to the use of Electronic Records and Electronic Signatures are summarised in 21 CFR Part 11:

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Authenticity: Users and administrators of Electronic Records have to be clearly identifiable and authentic in the system.

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Integrity: Electronic Records data must facilitate clear reference to the documented processes. All of the changes during the process have to be documented.

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Non-repudiation: The electronic signature which is inseparable from the electronic record has to clearly identify the author responsible.

Testo has validation-capable products, software and services to meet the ever growing demand for certifications, qualifications and validations.

A well-planned validation carried out on the complete system in conjunction with Testo data loggers and Testo software increases process efficiency in your company and will cut costs and risks in the long-term.

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Testo Products Fulfill FDA Regulation 21 CFR Part 11 by using measuring instruments and software from Testo

Measuring instruments - Software systems Testo data loggers have proven themselves in more than 10 years of practical applications. Long-term experience in production and service and with our customers serves as a basis for verifiable operational reliability.

The most important criteria for validation in accordance with 21CFR11 are the clear-cut identification of the instrument and the possiblilty of monitoring access. For this reason, our data loggers have a serial number and also the option of protecting the measurement program from unauthorised access by way of an instrument password.

ComSoft 3.3 Version 21CFR11 A validation-capable ComSoft 3.3 Version 21 CFR 11 was developed especially to manage and file process data. All of the FDA requirements can be fulfilled if used as part of a cohesive system:

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User management in User Groups by Administrator (using Windows 2000 rights management and three additional ComSoft-specific user groups)

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Save raw data in tamper-proof file format

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Complete integration in the Windows 2000 security system (certificates, rights management, user and password management, user authentification)

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Option of data export in generally readable PDF file format e.g. to send to the FDA validation point responsible or to display during a company audit.

Validation-capable testostor 171, testo 175, testo 177 loggers

Recognition of transfer errors using proof totals Inactivity lockout to prevent unauthorised access Monitors logins and logouts, successful / failed use of digital signatures and modification of raw data with the aid of Audit Trail

User management in user groups

As a market leader in the high quality measurements systems sector, Testo places major emphasis on the absolute security of their measured data. In the ComSoft 3.3 conforming with 21CFR11, we have consciously built on the existing Windows NT security concept by the software developer, Microsoft, for security based access monitoring, rights and the documentation required. The core operating system by Windows NT was successfully tested by NCSC in the C2 security level of the Orange Book.

For this reason, the security of the user authentification and Audit Trail as well as the file protection of Electronic Records (using NTFS standards) is guaranteed in ComSoft 3.3 Version 21 CFR 11.

Display: Limits exceeded (red) in table format

Graphic display of readings

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Testo Calibration Service

Service - Calibration Calibration involves the comparison of a measured value with the correct value in specified conditions, documentation of the deviation, calculation of the measurement uncertainty and the issue of a certificate. The use of ISO or DKD certificates from accredited test laboratories are particularly recommended for processes related to quality.

Service - Qualification Fulfillment of all the specification requirements are documented by proof of the technical suitability of systems involved in quality processes. This applies to new systems (prospective qualification) as well as to existing systems (retrospective qualification). The qualification of the whole working area implies additional calibration of the measuring instruments used.

In future, it may be required that the qualification is carried out by a neutral company.

Service - Validation in your company Thanks to its many years of experience with highly accurate measuring instruments to monitor processes, Testo is also the ideal partner for carrying out the complete validation package on-site in your company.

We can offer you our efficient calibration, qualification and validation service.

Please ask your Sales contact for full details on the different service packages available.