Process Specifications, Input/Output Design, Process Life Cycle : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

Process Specifications, Input/Output Design, Process Life Cycle

Documenting, analyzing, and explaining decisions made based on input data is imperative for the creation of output data from process input data.

Process Specifications

Documenting, analyzing, and explaining decisions made based on input data is imperative for the creation of output data from process input data. In other words, it lays down and specifies the requirements and procedures as they relate to regulatory/engineering requirements. A clear and complete process specification is necessary for high-quality, consistent data. An organized process specification reduces ambiguity, providing a way for individuals or organizations to determine exactly what tasks and accomplishments were achieved, and the validity of the design of the system, including the data dictionary and flow diagrams.

A process specification is created for primitive processes (minispecs) and for higher-level data flow diagram processes (process specifications). Formulas and algorithms are used as communication tools to communicate engineering requirements and procedures to companies engaged in the development of the process. Structured English, decision tables, decision trees and decision trees are the best ways to represent process logic. There are many ways to describe processes, either through a form or through a CASE tool repository. For processes with physical input or output, for processes that represent simple data validation, or for processes that already exist with pre-written code, process specifications are not created.

Input/output design

Input design

When raw data is input into an information system, it is processed to generate output. When designing input devices, developers need to take into account input methods such as PC, MICR, OMR, etc. This implies that the quality of the system output depends on the quality of the system input. The following properties are present in well-designed input screens and forms.
  • Store, record, and retrieve information effectively should be among the functions of any storage system.
  • The system should ensure accurate completion.
  • The system should ensure accurate completion.
  • Consistency, simplicity, and user attention should all be focused on.
Basic design principles are used to ensure these objectives.
  • Which inputs are required for the system?
  • Understanding how users interact with screens and forms.

Objectives

Designing inputs has the following objectives:
  • Procedures for entering and entering data
  • Reduce the input volume
  • Develop a method for collecting data or design source documents.
  • A designer designs input data records, user interface screens, data entry screens, etc.
  • Developing effective input controls and utilizing validation checks.

Input integrity controls

Several methods are employed to ensure end-user input is accurate and error-free. A value check is also performed on each field, both for its format and its completeness. Transaction logs record all entries and system operations to provide security and a way of recovering from failures. Data entry and system operations are audited in this way.

Output design

Input design has the following objectives:
  • Create output designs that serve the intended purpose and eliminate unnecessary outputs.
  • Design output to meet the requirements of the end user.
  • To provide accurate output quantities.
  • Format the output appropriately and direct it appropriately.
  • Making good decisions requires the output to be available on time.
Outputs can be produced in the following ways.

External output

External printer outputs are designed and created by manufacturers. Using external outputs, the system can enable their recipients to follow up on their trigger actions or confirm their actions. Outputs designed to be used as turnaround outputs are implemented as a form and re-entered into the system as inputs.

Internal output

Users and managers can view and use internal outputs inside the system. Reporting and decision making are supported by internal outputs.

Three types of reports are generated by the management information system
  • Detailed reports - Information contained in them is almost completely filtered and restricted, limiting its potential for usage in management planning and control.
  • Exception report - Exceptions are found in these reports, as data is filtered and conditional before being presented as information to the manager.
  • Summary reports - For managers who don't want details, they summarize trends and potential problems and categorize them.

Output integrity reports

The output integrity control consists of routing codes for identifying the recipient system and verification messages for confirming that messages handled by network protocols were received successfully. A printed or screen-formatted report should contain the date/time the report was printed as well as the data. For multi-page reports, report titles and descriptions should be included. Version numbers and effective dates are usually included on preprinted forms.

Process life cycle

Operating systems recognize five states in which a process may be starting from the time a request for execution is made, to the time it is executed by the system. There are four states in which a process can exist:
  • Process state
  • The process queue acknowledges the submission of the process it submitted.
  • A new status is assigned to the process after the acknowledgement is made.
  • Ready state
  • The process then enters the Ready State, where it waits for an OS processor to be assigned
  • Running state
  • Waiting and Termination state
  • The following transitions can now be followed by the process -
  • Processes may have all the resources they need and may proceed directly to termination state if the resources are available.
  • There are a few different reasons a process might need to wait.
  • By requesting values from the user, the user can access the input/output device via a console
  • If a higher priority operation is required, the process may be intentionally interrupted by OS
  • There may be a memory or resource access that is being used by another process, so the current process is placed in a waiting state and waits for the resource to become free.
  • It can directly go to termination state or need to wait for a possible input/resource/priority interrupt once requirements are met, for example, when it is returned to the execution state or locked resources are made available.
  • Termination
Get subject wise printable pdf documentsView Here





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


No comments:

Post a Comment

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts