{"id":35513,"date":"2015-09-17T05:20:58","date_gmt":"2015-09-17T02:20:58","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35513"},"modified":"2015-09-17T05:20:58","modified_gmt":"2015-09-17T02:20:58","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-computerized-system-validation","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/en\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-computerized-system-validation\/","title":{"rendered":"Computerized System Validation"},"content":{"rendered":"

\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4<\/a> -Computerized System Validation<\/h2>\n

\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n

Each system has a specific life length dependent on the time taken for the system to become outdated; this life length is called System Life Cycle\u00a0–\u00a0SLC<\/p>\n

The SLC is defined as an organized method to plan develop, test, modify and maintain a computer-based system<\/p>\n

:The SLC requires the following<\/p>\n

Unit tests – The test protocols shall be traced to low level design document and will be approved by the user prior to execution. The approval of the report shall be performed by representatives of the user's validation team, IT QA<\/a><\/p>\n

Management<\/p>\n

Requirements<\/p>\n

Design<\/p>\n

Implementation coding<\/p>\n

Integration<\/p>\n

Installation<\/p>\n

Operation and support<\/p>\n

Maintenance<\/p>\n

Change control<\/p>\n

Management<\/p>\n

Management must identify and provide an appropriate validation environment. Refer to Code of Federal Regulations (CFR) 820.20 which is a law issued by the US<\/p>\n

:A plan must be developed to include<\/p>\n

Validation tasks for each life cycle system<\/p>\n

Methods and procedures for each validation task<\/p>\n

Criteria for initiation and completion of each validation task<\/p>\n

Inputs for each validation task<\/p>\n

Outputs for each validation task<\/p>\n

Criteria for defining and documenting outputs in terms<\/p>\n

Requirements<\/p>\n

:Electronic Records<\/p>\n

The system\/product should ensure cover of the following requirements, related to Electronic Records<\/p>\n

The system\/product must generate accurate and complete copies of records in both human and electronic form<\/p>\n

The system\/product must protect records to enable their accurate and ready retrieval throughout the records retention period<\/p>\n

The operational system\/product checks must enforce the proper sequencing of steps in a process,<\/code>\u00a0as appropriate<\/p>\n

:The system\/product must ensure that only authorized individuals can<\/p>\n

Criteria for defining and documenting outputs in terms<\/p>\n

Use the system, logical access<\/p>\n

Electronically sign a record<\/p>\n

Access the operation or computer system input,\u00a0including time\/date and idle session<\/p>\n

Access the operation or computer system output device<\/p>\n

Alter a record<\/p>\n

Audit Trail<\/p>\n

The system must cover the following requirements related to Audit Trail<\/p>\n

The audit trail must be secure<\/p>\n

The audit trail must be computer generated<\/p>\n

The audit trail must include time and date stamp<\/p>\n

:The audit trail must independently record the date\/time of operator entries and actions that<\/p>\n

Create electronic records<\/p>\n

Modify electronic records<\/p>\n

Delete electronic records<\/p>\n

The system\/product must ensure that changes to electronic records cannot obscure previously recorded information<\/p>\n

The audit trail records must be maintained for at least as long as the retention of the underlying records<\/p>\n

The audit trail records must be available for review and copying<\/p>\n

Electronic Signatures –\u00a0ES<\/p>\n

The system will relate to ES (linkage between the record and the signature) during the working process under the following requirements<\/p>\n

The ES must contain the printed name of the signer<\/p>\n

The ES must contain the date and time of signing<\/p>\n

The ES must contain the meaning of the signing,\u00a0such as approval, review, responsibility etc<\/p>\n

The ES must include a part of any human readable form of the electronic record,\u00a0such as electronic display and\/or printout or report<\/p>\n

The 3 items above must have the same controls as for electronic records<\/p>\n

The signatures linked to their respective electronic records must ensure that these records cannot be cut, copied, or otherwise transferred by ordinary means for the purpose of falsification<\/p>\n

The system must ensure that the electronic signature is unique to one individual and not be reused by, or reassigned to, anyone else<\/p>\n

The electronic signature must employ, at least 2 identification components, such as identification code and password<\/p>\n

The system must enable customization of workflow signing rules (using one or all signature components in different scenarios), when an individual executes a series of signings during a single or continuous period of controlled system access<\/p>\n

The system must be contained into a unique Digital Signature (biometrics, token, cards, cryptographic symbols etc<\/p>\n

Controls for Identification Codes\/Password<\/p>\n

The combination of the identification code and password must be unique<\/p>\n

The combination of the identification code and password must be revised,\u00a0e.g., to cover such events as password aging<\/p>\n

Unauthorized use of password identifications and devices must be reported to the system security unit and\/or management, as appropriate<\/p>\n

\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n

\"\u05d0\u05d9\u05dc\u05df<\/a><\/p>\n