Christoph Knez, Sr. Account Executive, Pilgrim EMEA
Data Integrity is one of today’s hot topics in the Life Sciences industry. Look at the agenda of just about any industry conference, summit, or workshop event over the last two years, and you’ll notice Data Integrity has found its way into nearly every one.
If you listen carefully to attendees and others in the industry who are responsible every day for ensuring data integrity, you’ll hear how this very complex requirement creates a lot of anxiety among many companies when they examine their particular quality management processes. Their main objective is to avoid any observations by regulatory bodies resulting from data integrity issues. But why is it so complex?
What do regulatory bodies expect from you?
The U.S. FDA and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) expect that data be reliable and accurate. By definition, Data Integrity is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. This does not sound complex, but requires discipline and properly written and executed standard operating procedures (SOPs), something which should be customary within the highly regulated Life Sciences industry.
Are your processes old school or new?
Data Integrity applies to both paper-based and electronic quality management systems in laboratories, production, logistics, etc. Running a fully paper-based system only, or running an electronic system across all processes, theoretically should not create big issues in and of themselves. In theory, both approaches only require the discipline needed to successfully ensure data integrity.
However, reality is different. Today, most companies have a blend of paper and electronic processes. But even among those that have successfully managed to implement fully electronic solutions across all processes, quite a few still maintain electronic information islands, isolated data silos, and potentially outdated records. Those companies should not feel too comfortable; they should be worried about their data integrity. Those that run paper-based and electronic processes side-by-side will have the same issues. How can they ensure that accurate data is being transitioning from paper into electronic?
Are your current data management processes putting you at risk?
As awareness about the criticality of data integrity grows, organizations are developing SWOTS (analysis of strengths, weaknesses, opportunities, and threats) or similar strategies to identify their degree of vulnerability with regard to data integrity.
Typical Strengths reported:
- Most implemented systems do have upgrade capabilities
- Employees responsible for data input are trained to be precise and accurate
- Most of software used has individual user access
- Most spreadsheets are password protected, validated, and follow internal procedures per SOPs
Typical Weaknesses identified:
- Data backup (is it being done, how often, frequency, where stored, etc.)
- Traceability (missing audit trails)
- Specifically designed software being used for other purposes (example, generic ERP for specific quality management-related processes, etc.)
- Lack of computer validation
- Shared user access and shared passwords
- And many more
Do you want to amp up your approach to data integrity?
Even bearing the typical strengths identified above, more progress may be required before organizations can truly feel confident in their data integrity. Spreadsheets are a good example. It is cumbersome and resource-intensive to maintain data integrity using spreadsheets. Is it a strength to define that most of the systems have upgrade capabilities? As for the weaknesses cited above, these may only be the tip of the iceberg. There are certainly more if one digs deeper into a given organization.
Maintaining a purely paper-based system may be a good option for small organizations. They can certainly maintain good data integrity combined with well-trained personnel and up-to-date SOPs. But consistency could still be problematic.
The majority of organizations in the Life Science industry use both paper- and electronic-based processes. In order to make sure data integrity can be applied to the utmost extent, these organizations should ask themselves:
- Would it be better to eliminate disparate solutions and replace them with a harmonized system?
- Would it be better to select a system that provides the greatest possibilities of closed-loop processes to avoid redundancies and paper outside the solution?
- Would it be better to have a system that complies with the regulations, such as full audit trails, electronic signatures (CFR Part 11)?
- Would it be better to have a system that provides modern integration capabilities to ensure data integrity across different systems?
- Would it be better to have a system that provides multi-language capabilities to support local users and avoid data integrity issues caused by language issues?
Have you got a grip on data integrity yet?
Certainly, requirements surrounding data integrity will impact all of us over the next few years until the point is reached at which compliance issues caused by data integrity problems will be scarce. When Life Sciences companies unanimously respond positively to each of the aforementioned questions, we will be there, or certainly close.
Start taking control sooner than later.
SmartSolve®, from Pilgrim Quality Solutions, is a proven resource for getting data management under control. 21 CFR Part 11-compliant SmartSolve allows you to gain better control and visibility of your quality processes, boosts your confidence in your product quality, and prepares you for successful regulatory audits.
21 CFR Part 11
Industry Regulation White Paper
This document presents the requirements set forth in 21 CFR Part 11, along with Pilgrim’s own interpretation of the requirements.