Guardian

application framework

The software is able to manage out random multicaratteristica against which you can use multiple control devices, connected to one or more personal computers. Where reality produttivva which is aimed more complex, the characteristics listed GUARDIAN is a module, allow distribution of system functions to monitor multiple locations so that the simultaneous visibility on the results.

Appropriate mechanisms for the allocation of competences (enable features), governing access to such information. Each station can be connected more devices, the type depending on the type of control that the manufacturer's specifications require to be made, as well as peripherals such as printers, magnetic card, optical drives, etc. ....

GUARDIAN can be connected with all other modules of our system (LIMS Dispensing Area Management System, etc. ...), and evntualmente with company procedures for acquiring information or non-priority system, however, useful for automatic generation of such generate work orders the opening of the production lot.

KEY FEATURES

The data structure upon which the application GUARDIAN provides for the establishment of the archive of reference, namely the "cards" that describe, in front of a product code, which controls (tests) are expected during operation of the product code concerned. In defining the individual essays, you can determine the characteristic supervised, the type of test (for variable, attribute, defects), and data that describe the sampling plan to be applied, on which will be expressed in the opinions of accordance with standard specifications. The system allows you to apply the laws of various kinds, the most commonly used (FU, Presidential Decree 392, MIL-STD 105D), to those which include sampling plans defined ad hoc (Cucconi). The user has the possibility to define the responsibilities of various positions which make up its systems with control, then assigning tasks depending on the type of each test. During operation, the user has an automatic feedback of the activities to be carried out and, after selection, one can make the required inspections, using an extremely simple and intuitive interface.

The required data can be collected directly by equipment connected to the PC and / or entered manually by typing on the keyboard. The sample to be inspected, of size set of parameters that characterize the Wise, is evaluated based on criteria adopted by the Statistical Law. The partial processing and / or sheet can be obtained on a single machine, single item dispenser machine and / or lot, considering data from different machines, providing the user with the response iimediata compliance than under control. Depending on the type of feature to be tested, GUARDIAN allows you to specify the mechanisms of diversified, adaptable to the requirements set by the situation.

Nl case of "uniformity of weight control (for example), the system allows you to specify, among other things, the weighing mode (Gross / Net Gross / Tare, Tare fixed, etc..), The type of weighted (single or additive). After the necessary verification of the specific case you can implement a total automatic control operations: if the weight control properties of small size using an automatic feeder (eg METTLER LV-10), together with a balance, can simplify the operations that require human intervention (assuming that the production machine is properly prepared expulsion of parts making up the sample.) As noted during the production (including the notes that you can enter at any time), is processed and stored and, at any moment, you can get feedback through computer graphic design (control charts, frequency histograms, maps X Sigma, etc ...) and / or hard copy (reports obtainable through the use of multiple "filters" to identify what interest).

Judgement

The audit is expected to sample type and specific assessment of the controls are defined at the level of single test (and therefore for each of the features of control). The processing of acquired data requires the application of the above specifications that describe the sampling plan, which allows a protection against the risk of rejecting lots complying (first type), and the risk of accepting non-conforming lots ( second type), the latter essential for the pharmaceutical sector.
The results obtained with regard to single fraction of control and / or production lot, are available in real time through interactive graphics and / or through print extremely detailed, showing the requested information by setting appropriate filters.

Processing

GUARDIAN make a historicizing the lessons. The data is visible at any time and in which it is possible to make calculations for the assessment of trends in production on various processing lines.
The archive can be sized appropriately based on user needs, by the backup feature, you can store as required. The procedure also runs guided recovery of stored data when their vision was needed, processing and / or printing. It 'will also be a feature of exporting data in this mdo available to other statistical procedures (as StstGraphics, SAS, etc ...)

Validation

GUARDIAN provides documentation for validation, necessary for inspection by the official inspection bodies. On request we can also show, get a deposit fiducial at the Notary's source.

Rule 690/78 

GUARDIAN control work in progress feature weight, has among its functions the choice of compliance for that characteristic, as provided by the Official Pharmacopoeia Italianaed. IXa for drugs, and dellaLegge 690/78 and subsequent round of integration, for Pre-packages.