Data Integrity in a New QMS

Data Integrity isn’t just a buzzword; it is a way of life. As with any life change—marriage, moving to a new city, having a new baby, for example—there is a period of adjustment. For a startup company, the new way of life is a flurry of activity—developing the product, satisfying investors, and hiring a workforce—that can lead to stress, overwork, disorganization, and lost sleep.

It is a requirement for a medical device startup company to develop a QMS (Quality Management System). The major purpose of a QMS is to provide a structure to assure an organization can fulfill customer and regulatory requirements. A key aspect of the QMS is management involvement in decision-making, and decision effectiveness is based on accurate information.

Accurate information results from data integrity. For this reason, data integrity controls must be incorporated into the new QMS, even when a startup company has so many competing priorities. Data integrity can be seen as a tradeoff of short-term expediency for the long-term payoff. Similar to the decision to spend money on a gourmet coffee today, or to allocate that sum to a savings account for a dream home, spending extra time to investigate the root cause of a laboratory problem can cost you a year of recurrent future problems.

Data integrity is also a cost avoidance, and it is no more evident than during the product development process for the medical device startup. Objective review of test data for prototype devices can result in “fast failure” to eliminate problematic prototypes from the start. Audit trails to identify who performed the testing, as well as when, and how, provides context around test conditions to understand the test conditions leading to product failure. The cost of a failed clinical trial needs to be avoided, as this can impact the company’s very survival.

Eventually, the company’s survival depends on a passing FDA inspection. Data integrity breaches are costly to remediate after an FDA inspection but are relatively inexpensive to avoid. Data integrity does not need to be sophisticated and can be implemented with a paper-based system through instrument calibration and validation, and through manual verification of calculations, experiments, and documentation. Once the startup company has established a routine process and has a revenue stream, it can begin to search for electronic systems that use individual user logins, audit trails, and electronic signatures to maintain data integrity.

Startup life sciences companies need to include a policy around signatures, records, document management and data integrity within the QMS and ensure affected employees trained on this policy. This will safeguard the company from a cost-avoidance standpoint and develop goodwill with the FDA, which will speed product approvals and market access. If you have questions about QMS development or data integrity, contact the experts at Compliance Team.