Manual handling of requirements, design, traceability and testing with associated manual recording of results is still legion in many cases. Especially in regulatory controlled organizations such as the pharmaceutical and medical technology industries. The manual processes have a large number of limitations such as:
- Administratively heavy and often resource-demanding from work considerations.
- Time inefficient and repetitive.
- At risk due to sources of human error.
- Creation of large volumes of paper documentation.
- Impractical or impossible for recurring upgrades of systems, projects, flows and equipment.
- Inefficient in terms of test coverage.
It doesn’t have to be that way.
Support for requirements, design, testing, traceability and defect management
As tools, methods, processes and not least technology develop, there are good conditions for moving to electronic management of both requirements, design and the test process, as well as associated defect management over the system’s entire life cycle.
Tools such as Micro Focus ALM, Octane och qTest can be advantageously used for requirements management, design, test cases and deviation management as well as associated traceability and reporting. In addition, automation tools such as UFT and test data tools can be integrated to create test flows with higher test coverage and above all the possibility to streamline and enable testing to a completely different extent than a manually corresponding process. Standardized products that are set up and supplemented with processes, routines and associated control documents can provide a very effective process for managing the life cycle of computerised systems. Lemontree’s complete and ready LTE-framework can be easily applied to achieve the desired goals.
Automation to ensure that systems, applications, flows or the function acts as they have done in the past is standard in many industries. Positive testing against defined specifications, for example requirement, function or design specifications can be set up technically with ease. For example, when the system is commissioned for the first time and afterwards for efficient testing of system upgrades. For example. when patching software or automatic releases over the network.
Basically all types of systems with user interfaces. From LIMS, ERP, MES, SCADA to web services or Excel sheets can be test automated. It can be business systems such as SAP, IFS or Dynamics. It can also be medical equipment to be controlled or software for data analysis, logistics, labs, drug prescriptions, pharmacovigilance, etc. The list can be made long.
If we assume that your software (system, several connected systems or functions) needs to be updated, this usually means large manual work efforts to cover test needs by creating and approving test documentation and then clicking through all functions, options, scenarios, selecting combinations, drop-down lists and control functions. If it is also within a regulatory controlled environment, the documentation requirements are also great.
By automating the testing, a greater test coverage can be achieved and the quality can be increased in a way that is impossible with manual steps. Read our White Paper on how to get started and integrate automation into GxP-workflows.
Let us at Lemontree show you how your quality assurance process can be streamlined and still comply with current legislation and GAMP5.