66Validation

21 CFR Part 11

FDAThe American FFood and DDrug AAdministration regulatory authority isresponsible for monitoring production processes in the food, chemical andpharmaceutical industry. Also companies which export to the US aremonitored by the FDA and are subject to their regulations.

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

CFR The CCode of FFederal RRegulations, as a body of rules and regulations, isobligatory for the industries involved. The code is divided into separate titleswhich are mostly drafted according to result so that it is left up to thecompany to select the most suitable method.

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

21CFR Part11Part 11, which came into effect in 1997, deals with electronic records andsignatures. They are equated with manual documents and signatures whenTitle 21 CFR Part 11 is adhered to.

GMPThe EU GGood MManufacturing PPractice handbook is a standard volume whichregulates the manufacture and import of pharmaceutical products for use inthe EU.

SOPSStandard OOperating PProcedures provide directions for people manufacturingpharmaceutical and food products. They serve to minimise applicationerrors and for liability purposes. They are adapted specifically to acompany`s needs and connect the performance of the measurementtechnology with the environment of the process when data loggers are used.

Testo has specifically adapted the operating concept of ComSoft 3.3 inconjunction with Testo data loggers such that the number of possible humanerrors and also the range of SOPs necessary are reduced. Safety risksspecific to applications are, of course, still covered by appropriatedirections.

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21 CFR Part 11

Validation

ValidationThe manufacturers of FDA regulated products, in particular pharmaceuticaland chemical products as well as foodstuffs are subject to strict validation oftheir processes. The American regulatory authority Food & DrugAdministration stipulates uninterrupted documentation and long-term filingof process variables. Authority regulations in relation to the use of ElectronicRecords and Electronic Signatures are summarised in 21 CFR Part 11:

· AAuutthheennttiicciittyy:: Users and administrators of Electronic Records have to beclearly identifiable and authentic in the system.

· IInntteeggrriittyy:: Electronic Records data must facilitate clear reference to thedocumented processes. All of the changes during the process have to bedocumented.

· NNoonn--rreeppuuddiiaattiioonn:: The electronic signature which is inseparable from theelectronic record has to clearly identify the author responsible.

TTeessttoo has validation-capable products, software and services to meet theever growing demand for certifications, qualifications and validations.

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

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68Validation

Testo Products

Measuring instruments - Software systemsTesto data loggers have proven themselves in more than 10 years ofpractical applications. Long-term experience in production and service andwith our customers serves as a basis for verifiable operational reliability.The most important criteria for validation in accordance with 21CFR11 arethe clear-cut identification of the instrument and the possiblilty ofmonitoring access. For this reason, our data loggers have a serial numberand also the option of protecting the measurement program fromunauthorised access by way of an instrument password.

ComSoft 3.3 Version 21CFR11A validation-capable CCoommSSoofftt 33..33 VVeerrssiioonn 2211 CCFFRR 1111 was developedespecially to manage and file process data. All of the FDA requirements canbe fulfilled if used as part of a cohesive system:

· User management in User Groups by Administrator (using Windows2000 rights management and three additional ComSoft-specific usergroups)

· Save raw data in tamper-proof file format

· Recognition of transfer errors using proof totals

· Inactivity lockout to prevent unauthorised access

· Monitors logins and logouts, successful / failed use of digital signaturesand modification of raw data with the aid of Audit Trail

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

· 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.

As a market leader in the high quality measurements systems sector, Testoplaces major emphasis on the absolute security of their measured data. Inthe ComSoft 3.3 conforming with 21CFR11, we have consciously built onthe existing Windows NT security concept by the software developer,Microsoft, for security based access monitoring, rights and thedocumentation required. The core operating system by Windows NT wassuccessfully tested by NCSC in the C2 security level of the Orange Book.For this reason, the security of the user authentification and Audit Trail aswell as the file protection of Electronic Records (using NTFS standards) isguaranteed in CCoommSSoofftt 33..33 VVeerrssiioonn 2211 CCFFRR 1111.

User management in user groups

Display: Limits exceeded (red) in table format

Graphic display of readings

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

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

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Testo Calibration Service

Validation

Service - CalibrationCalibration involves the comparison of a measured value with the correctvalue in specified conditions, documentation of the deviation, calculation ofthe measurement uncertainty and the issue of a certificate. The use of ISO orDKD certificates from accredited test laboratories are particularlyrecommended for processes related to quality.

Service - QualificationFulfillment of all the specification requirements are documented by proof ofthe technical suitability of systems involved in quality processes. Thisapplies to new systems (prospective qualification) as well as to existingsystems (retrospective qualification). The qualification of the whole workingarea implies additional calibration of the measuring instruments used. In future, it may be required that the qualification is carried out by a neutralcompany.

Service - Validation in your companyThanks to its many years of experience with highly accurate measuringinstruments to monitor processes, Testo is also the ideal partner for carryingout the complete validation package on-site in your company. We can offer you our efficient calibration, qualification and validationservice.Please ask your Sales contact for full details on the different servicepackages available.

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