By Donald C. Singer
Ebook via Singer, Donald C.
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Extra resources for A Laboratory Quality Handbook of Best Practices & Relevant Regulations
A quality function and the management of the area(s) having responsibilities defined in the procedure must approve all SOPs. Key points of the SOP controlling SOPs are: • Use a standard format/template; • Have a unique identity and version number; • Be written in the active voice; • Describe the objectives and scope; • Define definitions; • Describe any safety requirements; • Define management responsibilities; • Include any references; • Describe any appendices (diagrams, flow charts); • Describe the process of writing and approving SOPs; • Define approvals; • Clarify who has control of official copies; • Identify revision procedures, including review period; • Explain deviation approval process; and • Include document history.
Documentation is important to demonstrate software and system validation. The documentation should include a written design of what the software and system is intended to do and how it will do it. A written validation or test plan should be developed to include structural and functional analysis. Test results and evaluate the data to demonstrate that the specification of the system or software was met. The validation protocol should also ensure that changes to the software such as upgrades, equipment, component replacement, or new instrumentation will maintain the integrity of the electronic data.
The copy must be initialed and dated by the individual checking that the copy and original are exactly the same. CONCLUSIONS Electronic capture of data and information, and now electronic signatures, has changed the operations of the analytical laboratory. Equipment has the ability to analyze more samples for more tests in a faster time than was possible only a few years ago. The amount of data collected for interpretation and statistical analysis has increased many times. Conventional calculators are still used but the sheer volume of data requires computers to handle the data before being processed.
A Laboratory Quality Handbook of Best Practices & Relevant Regulations by Donald C. Singer