Unauthorized alterations

The unauthorized alteration of internal air thermostats and time switches ... 

The unauthorized alteration of set parameters is the most common problem and it is possible to install tamperproof... 

The implicit requirements in Part 11 include the availability of the tools necessary to display and/or print audit trail records, and associated metadata, in human readable form. Another important use of audit trails is the protection from subsequent unauthorized alteration and destruction, and to permit the detection of security violations and after-the-fact investigations into their cause. 

In summary, electronic records must be protected against loss, damage, and unauthorized alteration. 

A digital signature is used to ensure integrity of an electronic record, namely to prevent unauthorized alteration of the content of an electronic record. It is also used for nonrepudiation for an electronic transactions, namely to prevent a denial of an involvement in an electronic contract for a legally binding agreement. 

Technological Supplier ER/ES systems should be capable of recording all electronic record create, update and delete operations. Data to be recorded must include, as a minimum, time and date, unambiguous description of event and identity of operator. This record should be secure from subsequent unauthorized alteration. 

The equipment shall be in the custody of the Technical Secretariat and be designated, calibrated and approved by the Technical Secretariat. The Technical Secretariat shall, to the extent possible, select that equipment which is specifically designed for the specific kind of inspection required. Designated and approved equipment shall be specifically protected against unauthorized alteration. 

Access to electronic records should be restricted and monitored by the system s software through its log-on requirements, security procedures, and audit trail records. The electronic records must not be altered, browsed, queried, or reported by external software applications that do not gain entry through the protective system software. In addition to the logical security built into the system, physical security must be provided to ensure that access to computer systems and, consequently, to electronic records is prevented for unauthorized personnel. 

Data authentication To provide evidence that the data possessed by the system has not been altered or destroyed in an unauthorized manner. Examples of how data authentication may be assured include the use of an authentication code, or digital signature. ... 

Product Security Tamper-evident packaging closures and security tags should be used. Containers that appear to have been opened or otherwise altered by unauthorized persons should not be used until the purity of the substance has been confirmed. 

Trojan Horse FDA (1995) A method of attacking a computer system, typically by providing a useful program that contains code intended to compromise a computer system by secretly providing for unauthorized access, the unauthorized collection of privileged system and user data, the unauthorized reading or altering of hies, the performance of unintended and unexpected funchons, or the malicious destruction of software and hardware. 

Data should only be entered or amended by persons authorized to do so. Suitable methods of deterring unauthorized entry of data include the use of keys, pass cards, personal codes and restricted access to computer terminals. There should be a defined procedure for the issue, cancellation and alteration of authorization to amend data, including the changing of personal codes. 

Revalidation Examine the need to revalidate, e.g., if many changes have been made or if regulatory requirements have altered. Check whether any unauthorized changes have been made. 

Inadequate control of inputs and changes. It is absolutely vital to ensure that only the authorized personnel have access to the work for which they are responsible that no unauthorized changes are possible and that all changes are recorded. For example, if an instrumentation engineer alters the data of an instrument for which he is responsible, this must not make a change to the P ID to which the instrument data is connected, without the authorization of the responsible process engineer. 

Scrambling The alteration of the characteristics of a video, audio, or coded data stream in order to prevent unauthorized reception of the information in a clear form. This alteration is a specified process under the control of a conditional access system. 

Eighth Data Protection Principle. Appropriate security measures shall be taken against unauthorized access to or alteration, disclosure or destruction of, personal data and against accidental loss or destruction of personal data. 

Containers or valves should never be altered or repaired by unauthorized personnel. Use only reducing valves and gaskets designed for chlorine. Consult the chlorine manufacturer for details. The Chlorine Institute has compiled industry recommendations for chlorine tank cars in Pamphlet 66, Chlorine Tank Car Loading, Unloading, Air Padding, Hydrostatic Testing [12]. 

Courts and other legal processes usually require proof that the laboratory has taken all reasonable precautions against unwanted tampering or alteration of the evidence. This applies to specimens and to physical exhibits used by the laboratory for toxicology investigations. Consequently, it is essential that the correct identifying details are recorded on the exhibit or specimen container and an adequate record is kept of persons in possession of the exhibit(s). Alternatively, when couriers are used to transport exhibits, the exhibit must be adequately sealed to prevent unauthorized tampering. 

According to [5], dependabihty is an integrative concept composed of the attributes availability readiness for correct service reliability continuity of correct service safety absence of catastrophic consequences on the user(s) and the environment confidentiality absence of unauthorized disclosure of information integrity absence of improper system state alterations maintainability ability to undergo repairs and modification. Such emergent system properties are usually demonstrated by argumentation in so-called dependability cases. 

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