Most Quality Management Systems will have evolved over time. For many this will mean the design and use of custom excel spreadsheets to manage Quality Control test data. With the recent updated regulatory guidelines with respect to data integrity, how compliant are these spreadsheets?
Let’s take a look into the background of this topic. The publication, by the MHRA, in January 2015 of its updated guidelines outlining pre-inspection compliance requirements garnered a great deal of interest from stakeholders who had questions regarding what data integrity encompassed. The MHRA released their March 2015 update in answer to this question, adding clarification to the text in the hope that the industry will take proactive measures to protect and secure their data instead of reacting or defending their data processes in the event they are audited. By providing industry entities with this information ahead of time, the MHRA is hoping manufacturers and wholesalers will design and operate systems that adhere to the guidelines and produce pharmaceuticals that are safe.
A useful acronym when considering data integrity is ALCOA; data must be attributable, legible (permanent), contemporaneous, original and accurate. So how does this relate to spreadsheets and what can you do to overcome the associated issues?
Regulatory concerns associated with the use of non-validated spreadsheets include:
The lack of an audit trail. Without this, the regulators will suggest that you have not captured changes that are made to data, the reasons for the change and who made the change. This leads to questions which include how can you be sure that the data has not been tampered with?
No electronic signatures. This is the stamp that confirms who entered the data. Without this, how can you be sure that the person who entered the data had the authority to do so and is adequately trained?
A lack of user security. Similar to the point above, anyone can enter or change data in a spreadsheet.
Limited password protection.
One way to overcome these issues is to deploy and validate a Laboratory Information Management System (LIMS) that has been designed to facilitate regulatory compliance of Quality Control test data. Act in this way and you will no longer need custom spreadsheets as the LIMS will manage the whole data management process. If you choose to take this route, make sure that the LIMS you select facilitates compliance and manages audit trails, user permissions, electronic signatures and password protection.
There are products you can consider to validate your spreadsheets but with LIMS removing this requirement as well as managing your whole sample test process in a regulated system and generating efficiency gains, it is likely to be the optimum route for many. You can expect to achieve sample processing time savings in excess of 50% with the added benefit of easy data trending which can be used to achieve productivity gains.
Next time you review your Quality Systems, remember that the regulatory hot topic is data integrity and include your compliance against the new guidelines in your risk assessment.