Quality assurance source documents

A data quality plan is a tool to aid in the implementation of data quality. The plan should be developed as soon as the protocol is finalized. Data quality is a shared responsibility across all functions. For example, the monitor assures quality by source document verification (SDV), and the clinician reviews listings of individual patient profiles and study outliers. ... 

All surveyors need a database of technical information, which should include reports of accidents or of defects that could lead to accidents derived from other sources. He also needs a regular supply of technical documentation from his head office that keeps him abreast of technical developments. If his company operates an effective quality assurance system, they will periodically check that he is keeping these data properly and they may control the indexing of them. 

The requirements for hardware validation are identical to those of any other equipment in use, comprising the OQ/IQ/PQ cycle, except that in the PQ, it is the test of software used. The software validation comprises functional testing, in which defined inputs produce outputs that meet expectations or specifications a thorough examination of source codes, database designs, programming standards, control methods, and support documentation or a quality-assurance program that includes alternate plans, contingency practices, record retrieval, and security practices... 

The level of control and validation documentation required (i.e., through increased testing and tighter specifications) increases as one moves closer, in a multistep, in-plant process, to the outcomes [i.e., final intermediate(s) and the API itself]. Naturally, when key and final intermediates are sourced from outside the company, they must enter with appropriate certificates of analysis (CofA), plus thorough inspections of off-site facilities by quality assurance personnel. 

Data screening and quality assurance checking were conducted at initial information retrieval and all data entries cross-checked during subsequent data compilation. Production/activity levels were verified against different information sources including annual records, selfmonitoring reports and ad hoc study reports. There was inadequate documentation of local industrial/commercial/urban activities and/or limited analytical data on the level of POPs contamination in some classes of emission sources. These were identified as inventory data gaps for followup actions. 

The second component of a successful clinical manufacturing program is appropriate quality assurance systems for the production of cell or viral banks, raw materials, in-process materials, and final product. Much has been written about the production and testing of cell and viral banks for use in manufacturing. Both FDA guidelines and other reference information are available (http // www.fda.gov.cber/guidelines.htm http //www.ich.org, http //www. emea.eu.int). The production of AAV vector batches for use in clinical trials should use qualified cell, viral, and/or plasmid banks as appropriate. Documentation on the source materials for these banks is also crucial in assuring the quality and safety of the clinical trial materials. 

Sample preparation involves physical and chemical treatments which are potential sources of bias, variance, contamination, and mechanical loss. Sample preparation should be planned carefully and documented in sufficient detail to provide a complete record of the sample history. Furthermore, samples taken specifically to test the quality assurance system should be subjected to the same preparation steps as the test sample. 

A Source Code Review must be performed on application software unless there is evidence from the Supplier Audit that the source code has been, or will be, developed in a quality assured manner and subjected to review as part of its development life cycle. The decision and justification not to perform a review must be documented within the Validation Plan. 

Validation approach, quality assurance and auditing Specification, design and Source Code Reviews Planning documents... 

Facdities should be designedand operated forthe comfort of the animals and the convenience ofthe investigator. Another critical factor in facility design operations involves the prevention of transmission of latent diseases from animal to animal, or animals to humans. The first step involves purchaseofanimals from clean sources who have a documented animal health quality assurance program. Newly arrived animals should be held in a quarantine area in the facility to prevent potential contamination ofexisting research animalpopulations. The quarantine facility should be located in an area adjacent to the main colony, but with separate access to prevent cross-contamination of the colony as would be the case with common traffic flows. 

Verification the process of determining whether the quahty or performance of a product or service is as stated, as intended or as required. Verification is closely related to quahty assurance and quality control. It is the evaluation performed to confirm the correctness of a written procedure or guidehne to ensure that technical and human factor concerns have been properly incorporated. EOF verification The objective of EOF verification is to determine that consistency has been maintained between the EOFs and the EOF source documents. Consistency is determined by verification principles of written correctness and technical accuracy. Written correctness ensures that information is incorporated as specified by administrative guidance. Technical accuracy ensures proper incorporation of generic and plant specific technical information. 

The test plans, procedures, expected results and reports on the tests should be maintained and should be available for quality assurance audits and third party assessments. The test procedures should present the rationale for each test case and provide for tracing of the test cases to the relevant source documents. The expected test results should be stated (with their method of derivation) in the test documentation prior to execution of the tests. 

The standard also requires that the instructions be derived from appropriate sources, such as the quality plan, the control plan, and the product realization process, which means that all instructions should be traceable to one or more of these documents. They should form a set, so that there are no instructions used outside those that have been approved by the planning team. This is to ensure that no unauthorized practices are employed. Another important aspect to consider is the use of informal practices - practices known only to the particular operator. Process capability should be based on formal routines, otherwise repeatability cannot be assured when operators change. 

Documentation of data origin is essential. Each completed data collection form needs to contain a file reference number or code to connect it to the documentation sources. This provides an essential trail to audit data quality, to confirm risk or reliability estimates or to investigate data values that appear questionable. Procedures to control data during handling, processing, recording, and reviewing are also necessary to prevent loss of data and to assure that opportunities are not lost to check the content of a form, by... 

The majority of analytical processes in regulated environments rely on computer control for automation and for data capture and evaluation. It is therefore important that not only is the instrument validated but also the computer and operational software. Validation of software is more complex than hardware validation, especially since source codes for many analytical processes can run to several hundred thousand lines. In this case the responsibility for validation still remains with the user, who should have the assurance that the computer system has been validated during and at the end of the DQ phase. The vendor should provide documentation with a declaration that the software has been validated to these or similar guidelines to ensure software quality standards. Further, the vendor should provide access to the source codes if required by the user. 

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