System validation important documents

A computer system is composed of software and hardware, equipment, a processor, and a user, and it is used to execute a specific procedure. Regardless of whether the computer system is developed in-house or by a contractor or purchased off the shelf, establishing documented end-user requirements is extremely important for computer systems validation. Without first establishing end-user needs and intended use, it is virtually impossible to confirm that the system can consistently meet them. Once established, it should obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications. It is important that the end-user requirements specifications take into account predicate rules [12]. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

Transdermal system validation requires certain elements in order to be successful. Some of these elements are planning, documentation, time, budget, resources, quality, understanding, and communication. To illustrate how important... 

In most instances and due to the system validation life cycle, a modification to a high-level document will invariably affect lower-level documents. These lower-level documents are called dependant documents, and it is important to identify and update all affected documents. 

The documentation supplied with the CDS application or system (both hardware and software), user notes, and user standard operating procedures will not be discussed here as it is too specific and also depends npon the management approach in an individual laboratory. However, the importance of this system-specific docnmentation for validation should not be underestimated. Keeping this docnmentation cnrrent shonld be considered a vital part of ensuring the operational validation of any compnterized system. The nsers should know where to find the current copies of documentation to enable them to do their job. The old versions of user SOPs, system, and user documentation shonld be archived. 

The Validation Plan documents the validation scope of the LIMS. The Validation Plan must clearly define the boundaries of the validation activities, including the responsibilities of each contributor, and will therefore identify what is within the boundary of LIMS (e.g., interfaces, reporting tools, etc.). It is vitally important to ensure at this stage that there is full validation coverage for LIMS and all associated systems. The Validation Plan will define a number of specific areas on which the approach to validation will be based ... 

In addition to validating each individual imported document a check should be made to ensure that all required documents have been imported. Failure to do this could result in critical documents being missing from the EDMS. As part of this hnal check the documents should also be checked to see that the EDMS contains the current version of all the documents in question in case documents have been updated since import. On completion of this validation step in a full life-cycle system the management of the documents in question should then be transferred to the EDMS. 

Considering the complexity of this endpoint and the breadth of the application of the system, the Guidance Documents are considered an important element in the operation of the harmonized scheme. (As noted above. Annex 10 is subject to validation.)... 

Can the vendor guarantee access to software development documents This question is particularly important for those working in the regulated environments. Shipment of a declaration of system validation with each software or computer system provides such evidence. This declares that each software product and their actual revisions have been validated and that additional information on product development can be made available. 

FieldNotes user verification can be conducted by following the SOP written by Astrix, which can be downloaded from the Astrix Web site. The SOP contains a script that is typed into the computer system. If the printout matches the SOP script, then verification is complete. A record of this must be placed in the facility archive. This verification process takes 1 h or less. For FieldNotes, calculations are not verified at the field site since the manufacturer feels that the software developer and the sponsors have performed adequate validation of these calculations previously. This may, therefore, require a visit to the sponsor or to the manufacturer to confirm that this important step of the validation process has been completed and is adequately documented. By following the Astrix SOP, the user is simply ensuring that the program operates on their system(s). The SOP script must be typed in exactly as written in order to confirm the printout accuracy. QA must ensure that the verification documentation is properly archived. Just as with any other SOP, this SOP must be approved in writing by field site management to comply with GLP. 

A validation protocol is a document that describes the item to be qualified, the tests and checks to be performed, as well as the results that are expected to be obtained. It is a file in which the records, results, and evaluation of a completed validation program are assembled. It may also contain proposals for the improvement of processes and/or equipment [1]. Validation protocols are important in ensuring that documented evidence is taken which demonstrates that an equipment item, a system, a process, or a method consistently performs at a specified level... 

Fit the purpose calibration. It is common sense to check instrument performance each day, and GLP requirements simply formalize the performance and documentation of these checks. On the other hand, it is also important to use the right test (full calibration, verification, system suitability test, or instrument and method validation) to verify the performance and to avoid needlessly lengthy procedures. As already discussed (see Sections 13.2.3 and 13.3.1), it is not always necessary to perform a MS full calibration every day. For example, if a particular MS is used only to record complete full-scan mass spectra, a daily calibration or verification of the calibration of the m/z ratio scale is required. However, in the case where a MS is coupled with an LC and utilized primarily for the analysis of one or more analytes in the selected ion monitoring (SIM) mode, it does not always require a daily verification of the calibration. In this specific case it is quite common in LC-MS and LC-MS/MS applications to test only the following performance parameters (a) sensitivity, (b) system precision,... 

The pilot-production program is generally a result of cooperation between the development laboratories and the manufacturing department. Technology transfer documentation applies to processes as well as to the systems being qualified and validated and their testing standards and testing methods. This documentation is important, particularly where an NDA is involved. 

User requirement specifications cover more aspects than only the GMP requirement, because the URS is not written only for the validation procedure in fact, a URS is a very important project document covering technical as well as economic requirements of the technical system. Pharmaceutical manufacturing departments not only check the GMP aspects of a system additionally, following good engineering practice they will review the technical and economic aspects of a technical system. Obviously, the more experience a company gains, the more comprehensive a URS become. Past experiences such as project faults, inefficient technical systems, and bad commissioning can be included in a URS. 

Traceability and accountability of information to be maintained throughout validation life-cycle documents (particularly important in relating qualification tests to defined requirements). The mechanism (e.g., matrix) for establishing and maintaining requirements traceability should document where a user-specified requirement is met by more than one system function or covered by multiple tests... 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

It must be made clear that the GMP quality-critical parameters and data are not open to interpretation and must be controlled throughout all life-cycle activities and clearly identified throughout the validation documentation. This is particularly important for parameters and data that need to be controlled by restricted access during the design and development phases and also during operation of the computer system. 

Once reviewed and approved internally, the URS is issued to prospective suppliers as part of the tender document set so that detailed quotations for the system application can be obtained. The contractual status of the URS and its importance to the validation program should be made clear to the supplier. 

An important objective of ongoing evaluation is to uphold an auditable system of validation documentation and ensure a controlled, fully documented record of any activity that may affect the validation status of the computer system and the computerized operation it is part of. 

As with any computerized system, it is important that the implementation of the electronic submissions system be documented and validated. Changes to the system must be controlled in order to maintain the system s state of validation. Refer to Chap. 7 for an extensive overview of computer validation. 

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