Our design experts provide complete technical engineering documents which includes –
Record information of the automation project from the Start to finish. These documents are divided in two forms –
Improve process efficiency, improve overall quality, decrease costs, save development time, eliminate flaws, ensure compliance with the documents and records provided by our team.
Procedural or instructional documents
Procedural document is the detailed document which explains the methods/ways to perform the operations.
Records; i.e. evidence of compliance
Records are, the documents either designed or generated from system, as an evidence of conformity to comply the system functioning as per the design.
Our design & document department can help you with various documents and record that are used throughout the manufacturing process, as well as supporting processes like Quality control or Quality Assurance. Document list include (but are not limited to):
A Batch Report is a document that provides the complete manufacturing history of a product. It aims to assure the safety and quality of the manufactured product by providing details of process parameters or steps followed during the execution of a manufacturing processes.
Hardware Design Specification (HDS)
The HDS Hardware Design Specification is a document that provides an overall description of the hardware and implementation. It provides description of main components and interactions and as well requirement for proper connection to utilities and installation.
A Process Cycle Report is a document that provides the details of process parameters or steps followed during the execution of executed cycle.
Software Design Specification (SDS)
The SDS Software Design Specification is a document that provides an overall description of the software, implementation, functions and interface with the users.
Functional Requirement/Design Specification (FRS, FDS)
The FDS provides the basis of the design of the system and will be used as well to verify and validate the system during the testing, ensuring all the required functions are present and that they operate correctly.
Audit trails provide evidence, enabling companies to track any modifications made to electronic records, including who made the changes, when they made them, and what they changed.
FAT Execution Protocol is the document made on the base of Design document to verify and test each component of machine as per acceptance criteria.
SAT Execution Protocol is a process document used to verify that a system meets the requirements of the customer or user.
Trend Reports & Operating Manual
Trend reports show how the value of one or more items changes over time. Operating manual is a document which provides the standard operating procedure to run the machine.
User Management Record
User Management Records represent the complete profile of each user in the system (Creation, deletion..). Policy related changes are also recorded in this record.
Recipe Record & Validation Documents
To capture the golden batch set-up, the recipe records are maintained for the executed batches. The validation documents provides a high degree of assurance to a desired result with predefined compliance
Risk Analysis / Risk Mitigation
Risk analysis document provide quantitative or qualitative process of linking the severity and probability of harm (severity being a measure of the possible consequences of a hazard) by evaluating the design/measures that have control over their occurrence and detection
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