Good Manufacturing Practice (GMP) is a set of guidelines created to ensure that production processes of goods follow quality and control standards. While GMP refers to the manufacturing of pharmaceutical goods, Good Distribution Practice (GDP) refers to the wholesale distribution of these goods. GMP and GDP vary from between countries, but rely on the same basic principles.
GMP/GDP principles require a safe and controlled environment that protects research information from loss or manipulation, including raw data and procedure protocols from all stages of production. This means that not only the lab work itself needs to comply with regulations, but the systems used for scientific data management — such as digital lab notebooks or informatics software — need to as well. Assuring the validity of a software involves assessing the risks that might be caused by each action in the system, and thoroughly testing to ensure that the risks are minimized.
We at Labguru understand that for some of our customers, research management systems must answer to GMP/GDP guidelines at the highest level. Therefore, we are now introducing a new model of validation for Labguru informatics software, implementing quality assurance, good manufacturing practices, quality control, and quality risk management.
In our new validation model, each new customer who requests a validated environment will receive a tailored validation plan. The validation plan will include:
In addition to validation performed within Biodata, the customer responsibility is to devise and perform PQ validation based on the organizations QMS, to verify that the informatics software complies with the intended use.
The development life cycle of Validated Labguru includes several key steps as described below. The proper execution of these steps is maintained and supervised by our Validation Management Team:
Before development starts, the impact of each change is assessed. The impact assessment serves as the guideline for new test protocols, and is a key component in the decision whether the FRS and MSA is to be updated when creating a new version.
Labguru development at Biodata adheres to the industry-wide accepted standards for developing web applications, including industry standards for graphical user interfaces (GUIs). Additionally, our code development adheres to the guidelines for software development per Biodata's internal protocols and practices as documented in Biodata’s QMS..
Biodata adhered to the highest quality and reliability standards. The quality assurance (QA) and testing procedures are based on a scaled agile framework.. Any changes to Labguru (for example a new feature enhancement) is released only after comprehensive testing efforts that include multiple individuals and an automatic testing system to ensure full testing coverage. The tests are done throughout the different phases of development to verify the new feature enhancement produces the expected results (i.e. that it is aligned with the functional requirements) and does not cause regression with the existing functions in the application or affects it’s performance.
All issues found throughout the validation life cycle are recorded and managed in a specialised software, and tracked from creation to resolution. The impact of each issue resolution (bug fix) is assessed and then tested and approved in the testing phase. Bug fixes are then added to the period release versions where they are tested again as part of the release.
For each update of validated Labguru the validation management team assesses all changes introduced into Labguru since the previous update and performs the needed updates to Labguru’s FRS, MRA and test protocols. A report is created to summarize the activity and to approve the validity of the new version. When a new version of Labguru is released, it is after thorough testing procedures that meet Biodata high standard of quality, reliability and traceability.
For more information about Labguru Validated Informatics Software, click here: