WHAT IS DATA INTEGRITY?
Data Integrity is the extent to which all data is complete, consistent, and accurate throughout the Data Integrity life-cycle. It must be attributable, legible, contemporaneously recorded and have an original copy.
WHY IS IT IMPORTANT?
Data Integrity can be compromised in numerous ways, whether it be human error intentionally or unintentionally. Data Integrity can come down to a life or death circumstance and therefore, companies must ensure that data is 100% accurate if governing bodies come back to your business.
Many manufacturers may not realise that Data Integrity in the manufacturing process is the most important aspect in the process. It is highly recommended that manufacturers use an electronic system to ensure greater control over the data and information.
Utilising an electronic system where this information is secure, automatically time stamped and can’t be maliciously altered, allows for greater confidence in the data.
Not being compliant can lead to warning letters and regulatory action from governing bodies. Every year there are reports of manufacturers falsifying data to get the products to market as quickly as possible.
HOW CAN MASON TECHNOLOGY HELP YOU WITH DATA INTEGRITY?
Mason Technology have numerous products and software programmes that can meet your Data Integrity needs and we are here to help with any queries related to Data Integrity.
Call Mason Technology today, to see how we can help be a solution provider for your Data Integrity needs!
All levels of management are responsible for quality and compliance in regulated laboratories.
Systems that are file based are not fit for use in regulated environments as it is easy to delete data, instead use a system with an integrated database.
A laboratory application must be configured to enable the audit trail, turn on electronic signatures and define user types with associated access privileges.
Design your work processes to work electronically for greater efficiency and speed. Validate the system for intended use, keep paper print-outs to a minimum, define electronic records/raw data for the system and sign the reports electronically.
Allocate each user a unique identity and use adequate password strength. When a person leaves or no longer requires access, disable the account to ensure that the user identity is not reused. Ensure the passwords are sufficiently strong and are not shared or written down.
Use the IT department to administer the system if possible to avoid conflicts of interest. For example application configuration settings and user account management.
Determine and document which analytical procedures can be adjusted and those which cannot, this control can include the data acquisition, instrument control and integration parameters as deemed necessary.
SOP defines hot interpret data for specific instrument types.
Staff must be trained in all the SOP’s applicable to the system. Training includes data integrity.
Carry out effective self-inspections or internal audits. Self-inspections must be independent and focus on ensuring data integrity within any system. Auditors must focus on the electronic records and working practices within the system rather than any paper records outside of it. If non-compliances are identified ensure that CAPA’s are effective and issues are not repeated.
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