Computer software documentation

Should you not use measuring devices in your organization, these requirements will not apply. If your means of verification are limited to visual inspection or professional judgement, as is the case with organizations that deal only with documentation, you will have no devices to control. However, you may use tools or computer software to assist you to determine conformance and these will need to be proven capable of producing a reliable result. 

U.S. Government Restricted Rights Notice Use, duplication, or disclosure of this software and related documentation by the U.S. government is subject to the Agreement with SAS Institute and the restrictions set forth in FAR 52.227-19, Commercial Computer Software-Restricted Rights (June 1987). 

Regulatory authorities recognize that, in spite of all the control systems put in place, deviations and changes are sometimes inevitable. A robust GMP system includes procedures to handle, review, and approve changes in raw materials, specifications, analytical methods, facilities, equipment, processes, computer software, and labeling and packaging. All the changes have to be documented with references for traceability. 

FDA Computer Investigation Expertise" and "Software Documentation" The Gold Sheet. July, 1986, 20, No. 7. 

Computer system documentation means records that relate to system operation and maintenance, from high-level design documents to end-user manuals. Sidebar 11-1 illustrates some typical SLC documentation. In the software-engineering context, computer systems documentation is regarded as software. All regulatory provisions applicable to software are also applicable to its documentation. 

The following process is applicable for changes to any component of computer technology that performs functions on regulated products, including hardware, peripheral devices, system software and utilities, application software, documentation, and communications hardware and software. These components can be either purchased from an external supplier or developed in house by the company or its designee. 

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. 

This Professional Edition of a pragmatic guide is designed to enlighten the industry at large, which suffers somewhat from the confusion created by earlier guidance documents now withdrawn. Written by an international expert in computer software and computer validation, it will become a classic of its kind when properly used to help companies implement their compliance requirements to meet the FDA and the MCA. 

The computer software your firm uses. .. is deficient. Your procedures do not require the documentation of calculation and entry errors. [FDA Warning Letter, 2000]... 

Check what has changed with computer system instrumentation, computer hardware, and computer software. Do design documents reflect these changes ... 

Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example Software such as Excel, Access, and Word used to create and maintain data bases (rejects, complaints, and concessions) and electronic documents, is not validated. 

The equipment hardware and computer software should be developed and validated according to a documented procedure, e.g., according to a product life cycle. The vendor should have a documented and certified quality system, e.g., ISO 9001. Quality must be designed and programmed into software prior to, and during, its development phases by following written develop-... 

CAP) inspection and accreditation checklists for laboratory computer software focus on documentation of practices that ensure the safe and reliable operation of the system, such as regular backup of data, validation of system function following software upgrades, and regular testing of the correctness of transmitted or printed laboratory results. 

Written instructions and procedures must be prepared to control and document the receipt of equipment, supplies, and services that affect the quality of measurement. Examples are reference materials (e.g., radionuclide standards), reagents, supplies (e.g., graduated cylinders, pipettes, planchets), and computer software and hardware. Controls should ensure that only correct items are accepted. If specifications are not met or the material is otherwise unsuitable, the QA officer should be notified and the material returned. 

National consensus standards that pertain specifically to computer software are available for reference, such as ANSI/IEEE Standard 730-2002 (IEEE, 2002). The user of equipment driven by software should refer to such documents to understand how the software will react under given conditions. When a user is unfamiliar with the intricacies of a software program, the results and their presentation are open to question. 

AR439 1.170 Software test documentation for digital computer software used in safety systems of nuclear... 

Some types of Karl Fischer instruments provide special capability of moisture analysis by utilizing a ramping oven feature that can differentiate surface from bound moisture in a single analysis. Optimizing moisture methods is simplified by computer software available to fully document sample analysis data treatment. 

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