Steps to Minimize the Data Integrity Risk

Data security and has become a hot issue in pharmaceuticals over the past few years because FDA and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records. Recently FDA has published a guideline in the form of question and answer for the compliance of data integrity in firms. These documents clarify the expectations of the FDA from pharmaceutical firms regarding data integrity.

According to the concept of ALCOA data should be Attributable, Legible, Contemporaneous, Original and Accurate. Data should be accurate and unchanged during its whole life. Data must be recorded at the time of the activity is being done and it should not be backdated.

The use of computers in industries is common and in the age of computers, it is easy to generate fake records. Sometimes it happens unknowingly but in most of the cases, employee generates the fake data to take a short cut or due to excess workload. Following are some strategies to minimize the risk of data integrity issues in pharmaceutical industries.

1. Audit Trail Implementation

Audit trail in any computerized system records all activities conducted on it. It records user identity, date and time of the activities done on the system. Audit trial helps to ensure the authenticity of the electronic records and their modification of deletion from the system. Each and every computerized system must be audit trail enabled.

2. Implementation of 21 CFR Part 11

21 CFR Part 11 has guidelines for the maintenance of electronic records. ALCOA principles are helpful to implement the recommendations of the 21 CFR. All electronic documents must have electronic signatures to make them trustworthy and reliable.

3. Computer System Validation

Computer software is responsible for the working of the computerized systems. Therefore all software used in computerized systems in the firm must be validated. Software validation ensures the efficient and error-free working of the computerized systems. In most of cased the software vendor provides the software validation and firm should ask for the same.

4. Secure Documents and Record

Pharmaceutical records must be secured and must not be assessable to all personnel. The access to the record should be restricted and authorized personnel must be allowed to access. The electronic data must also be password protected and it should be assessed by username and password.

5. Backup and Recovery

Each and every file of electronic record is important therefore a strategy for backup and recovery of data must be implemented. Periodic backup of data should be taken and must be stored in the form of DVDs or other data storage device so that it could be restored in any unexpected event of data loss from the instrument.

6. User Training

Proper training of the employees should be given for their assigned jobs. Special training for record maintenance and data integrity must be provided to all employees. The training for data maintenance should be included in the training calendar to repeat it periodically.

7. Internal Audits

Internal audits provide the confidence the employees and ensure the implementation of the procedures. The errors and problems found during the internal audits are rectified and continuous improvement in procedures and records take place.

As you know data integrity has its importance in the industries. The impact of unprotected records can be dangerous for its reliability as well as product quality. I have written many articles on data integrity because the data quality is not a focal point for many companies and issues are being raised by regulatory agencies. Record maintenance is entirely deferent from data integrity. It is not necessary that a properly maintained record would have integrity and accuracy.

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