Software Life Cycle Management and Computer Software Validation

 

Software Development Life Cycle Management – A systematic approach to developing software is a proven technique that allows for faster system development and fewer defects. CSI will work with your users, IT department and vendors on all aspects of the SDLC including:

  • User/Functional Requirements Specification – a high level description of what the user wants the system to do.
  • Detailed Requirements Specification – a detailed description that bridges the user’s needs with the ability of the programmer to build the system.
  • System Design – a detailed description of the system design.
  • System Build – actual system development.
  • Unit and Integration Testing – test plans and test execution showing that the system works.
  • Trace Matrix – a link between the requirements, design and final system to show that the system works as intended.
  • SOP Development – documentation on how the system works.
  • User Training – training on the system to show that the users know how the system works.
  • Change Control – once a system has been validated and is in production, it is critical that the system maintains its validated state by implementing change control.
  • Backup / Restore and Disaster Recovery – data is critical. Developing and implementing these procedures ensure that you will have your data when you need it.
  • Validation – a concept that is integrated into all the steps above. By correctly performing the above steps, your new system will be validated.

LIMS (Laboratory Information Management Systems)

LIMS systems are a valuable tool in streamlining data capture and processing. CSI will work with your laboratory team to assist in LIMS implementations and validate the system as per regulatory guidelines.

Database Management Systems

These systems are mission critical as they contain all the company data. CSI can assist your IT department by assisting in database design and validation.

Risk Assessment and Remediation of Existing Systems

Legacy systems can make you vulnerable during an audit. CSI can determine the areas of the pose the greatest risk and provide recommendations for remediation.

Computer Software Validation

Regulatory guidelines clearly state that software must be validated. CSI will work closely with your IT department to ensure that the regulatory guidelines are being followed.

Evaluation of Software Packages

Commercial off the shelf software (COTS) can prove to be an invaluable resource. CSI will use its vast experience to help you formulate the tough questions for the software vendors to make sure that your purchase meets your needs both now and in the future.

SOP / User Guide Development

Software systems can create and enhance efficiencies. Standard Operating Procedures and User Guides are necessary components used in the training process. CSI will work with you and the software vendor to develop SOPs and User Guides to appropriately document your system.

Process Design Mapping

When new systems are implemented, it is likely that the process will change and become more efficient. Process mapping is a critical task that aids both the software developer in creating the system and the user in defining his role. CSI can facilitate the process mapping by using their expertise in working with cross-functional teams.

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