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Data makes the pharma world go ’round. The United States continues to lead the globe in terms of pharma development and research, and issued more new drug patents than the rest of the countries in the top five put together between 2001 and 2010. Ten years on, the industry continues to forge ahead, with pharma spending expected to top $400 billion in 2020.
Of course, data from tests and trials is fueling this progress, but this is not the full extent of data to deployment in the industry.
We also have to consider other datasets, such as:
- Employee data
- Regulatory compliance data
- Plant and facility design data
- Plant and facility safety data
- Instrument calibration data
- Batch processing data
- Raw material quantity data
- Material storage and handling data
- And much, much more
To put it simply, data may be a driving force for the pharma industry here in the United States, but it can also be a burden. With so much data to process and manage, the integrity of the datasets — and therefore the reliability of the results derived from them — may suffer.
So, how do we ensure pharmaceutical data integrity?
Protecting the Integrity of Data Held in Electronic Records
Today, the majority of data is held in — or, at least, backed up by — electronic records. The rapid expansion of tech concepts such as cloud computing and remote access and collaboration has led to a rapid evolution in the regulations that govern electronic records. These include:
- ISO 15489: Records management
- ISO 23081-1, ISO 23081-2, and ISO 23081-3: Managing metadata for records (parts 1, 2 and 3)
- ISO 16175: Principles and functional requirements for records in electronic office environments
- As well as many other standards, including national and local regulation and compliance requirements
Beyond these regulations, there are a number of ways you can protect the integrity of the data you are using and storing. Begin by dividing the task up into five key areas.
1. Computing hardware / devices
- Make sure users can access data securely and with permission.
- Extend permission protection to all sensitive files and areas.
- Put protection in place to prevent cyberattacks.
- Make sure hardware is being monitored for operational errors.
- Put in place an upgrade schedule.
2. Software and applications
- Make sure all software and applications are secured.
- Make sure updates are carried out on schedule.
- Make sure all software and applications are in compliance with regulation.
- Make sure the vendor can provide ongoing support.
3. Users
- Hold ongoing training and education for users to make sure they are handling data in the right way.
- Attach expiry dates to passwords and log-in credentials.
- Outline a clear policy for removing user access or closing accounts.
4. Data backup and retrieval
- Put a policy in place for regular data backup.
- Identify key datasets and areas that need more regular backup.
- Enlist a team to handle data backup.
- Make sure backed up data is monitored and verified.
- Invest in software to quickly and easily retrieve backed-up data.
- Implement a reliable process for retrieving backed-up data when required.
- Implement a system to ensure reliable data archiving.
The above items are really just the beginning of proper pharmaceutical data integrity. Achieving this is an ongoing process, and one that you will need to pursue in the long term if you are to get the right results. However, the rewards are well worth the struggle.