Automation protocols processes

It seems pretty clear that easy-to-use and web-interfaced, automated protocols will be more and more useful in the near future. The possibility of combining different tools at different steps of the integrated process makes it inevitable that more of them will be developed and open to the pubhc. What is good about this kind of approach is that... 

We have developed a new process to improve the efficiency of sample reanalysis. This process includes four steps data review, replating, reanalysis, and data alignment. We have also generated an Excel template, a Gilson s Unipoint protocol, and an in-house visual basic program to automate the process. 

In this section, we present the development of an automated protocol for prostate tissue histology [164] from infrared spectroscopic imaging data as an example of the techniques described (Fig. 8.11). The data is three dimensional with x-y—axes representing the image plane and the 2-axis representing the spectral dimension. After data acquisition, two important pre-processing steps, namely baseline correction and de-noising, are performed. Since the entire data set is derived from human tissue samples, the spectra have similar characteristics and, therefore, a manually chosen set of pre-defined wave number could be used as the reference points for baseline correction. It is... 

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. 

One of the critical steps in qualitative and quantitative analysis is the sample preparation procedure. Sample preparation step can affect specificity, sensitivity, accuracy, precision, and throughput of a bioanalytical procedure. In addition to development and optimization of the chemistry involved in sample processing, the use of semiautomated or fully automated protocols has been... 

Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system as required by 21 CFR 820.70(i). For example your hrm s XXXX is computer controlled. It uses software programs to record data from measurements of the radius of curvature and comeal refraction of the eye. However, your firm has not validated the software and computer system used to record this data for its intended uses. Your firm has no documentation to assure that they perform as intended. Also, there is no validation and documentation of subsequent changes to the software. 

An important aspect is that of data and model stability. The raw data, for example, assay data, need to be updated regularly as new results become available. This process is tedious and time consuming and once a valid protocol for data acquisition and validation has been established, it is suitable for automation. The automatic procedure requires extensive data integrity checks (e.g., do all data points have valid structures and experimental results, how to handle conflicting results from different experiments) and a formalized automated normahzation process. This involves answering questions such as how to handle isomers, do experimental in vivo results have precedence over in vitro results or should all results be shown, should more confidence be put in results from Good Laboratory Practice (GLP)-studies, and so on. The models are then automatically rebuilt using the updated data and auto-updated as was mentioned in the QSAR section. A model may be promoted to use in the production system if it passes some defined validation tests, specific for each model, which was also mentioned earlier. 

A group of computers can become networked once intercomputer communication is established. Prior to the 1980s, all system suppHers used proprietary protocols to network their systems. The recent introduction of standardized protocols is based on the ISO-OSI seven-layer model. The manufacturing automation protocol (MAP), which adopted the ISO-OSI standards as its basis, specifies a broadband backbone local area network (LAN). Originally intended for discrete component systems, MAP has evolved to address the integration of DCSs used in process control as well. TCP/IP (transmission control protocol/internet protocol) has been adopted for communication between nodes that have different operating systems. 

Since data analysis is a complicated and very time-consuming task, attempts have been made to automate this process. Kurvinen et al. have developed an algorithm that allows automated assignment and quantification of TAGs based on MS data [35,36]. A similar algorithm was implemented by Liebisch et al. for determination of PC and SM species from PI spectra [37]. Han and Gross have published a protocol for the analysis of phospholipid and triglyceride molecular species (with acyl chain information) based on a two-dimensional matrix of data produced by multiple MS/MS scans [4]. We have recently developed a method that allows accurate quantitative analysis of lipidomes based on two-dimensional LC-MS data [19]. 

Once you have your SAS data ready for transport, you need to determine a means to deliver it. There are many ways to send data, but you should strive for process simplicity and data security. To keep your data secure and to comply with 21 CFR-Part 11, you need to encrypt your data files for transport. The best encryption you can use is key exchange high-bit encryption software such as PGP, which creates essentially unbreakable files when used properly. Once your data files are encrypted, you can either send them on physical media such as CD-ROM or send them electronically with secure transmission software such as Secure File Transport Protocol (SFTP). If you need to send data to someone once, a CD-ROM is simple enough to produce. However, if you need to send the data repeatedly, then you should use a more automated electronic method of data exchange. Shell scripts and batch files can be written to automate the electronic data transfer process. 

During the tissue fixation process, proteins are cross-linked, causing some epitopes to become undetectable by the staining protocols.10 HIAR reverses this effect, allowing these epitopes to be stained, and therefore has become increasingly important for many IHC staining protocols.19-22 However, the available automated IHC platforms vary in their ability to perform online HIAR. 

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