Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all department levels understand their roles and responsibilities with data integrity.
Let’s take a look at a few individuals’ responsibilities based on their job titles/ department:
Executives – Send a top-down message that data integrity violations will not be tolerated at the company.
Individuals at an executive level must ensure that employees have the proper data integrity training, as well as must be honest about their company’s own data; understanding when and how to report data integrity and guaranteeing ethical reporting it.
Operations – Demonstrate data integrity through paper and electronic documentation.
Individuals who perform and complete most of the manufacturing work are typically the ones audited by the FDA. They must ensure that the products have the safety, integrity, strength, purity and quality they claim to have before it goes to market.
Product Development – Ensure proper data integrity practices are carried out.
Individuals who perform research supporting clinical trials, where data integrity is extremely important, are responsible for guaranteeing data integrity when constructing accurate packages to drive change requests.
Quality – Be knowledgeable in regulations and means to report suspected violations.
These individuals can enforce data integrity in the organization by performing thorough reviews of audit trails.
Cleaners – Be knowledgeable on good documentation and how to report violations.
These individuals may need to document GMP cleaning which is a criticality to the manufacturing process. They must be aware of the significance of data integrity in order to know what a violation looks like for reporting and be able to properly log books.
Every employee in every department across your organization is responsible for data integrity. With informed employees on proper knowledge and understanding of each level’s role, corporations can ensure safer, more efficient, and higher quality drugs.
Source: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf