Having visited a number of Pharmaceutical and other regulated manufacturers in recent months it is interesting to note a number of common regulatory themes.

The vast majority are grappling with interpretation of the latest Data Integrity regulatory updates from bodies such as the FDA, MHRA and PIC/S.

All are aware that the drive to improve quality is a journey with no end, with many reaching the conclusion that traditional paper and excel based systems used to manage Quality Control test data are becoming increasingly difficult to manage in a regulatory compliant manner.

Significant drivers in this are found in the latest MHRA guidance. MHRA guidance states:

‘It is expected that facilities should upgrade to an audit trailed system by the end of 2017 .... It is acknowledged that some computerised systems support only a single user login or limited numbers of users logins. Where alternative computerised systems have the ability to provide the required number of unique logins, facilities should upgrade to the appropriate system by the end of 2017’

Note the timescale – by the end of 2017! So what in practice is happening?

Most are currently interpreting and applying the guidelines in their Quality Control laboratories initially to Chromatography Data Systems or CDS as they are commonly referred to as. This is not a surprise as recent high profile regulatory Warning Letters citing issues with the integrity of data in CDS. The CDS is used to program control of the chromatography system, create and store methods used in analytical tests and capture and store test results. It also has the ability to interface with other software such as a Laboratory Information Management System (LIMS).

We are therefore seeing a surge of activity around validating CDS and making the appropriate changes to ensure that Data Integrity within CDS is achieved. This is a significant investment in terms of time but once done ensures that the system is fit for purpose, fits its required use and meets regulatory requirements.

So, if like many of your peers, your lab is undertaking or has completed its validation of CDS what is the next logical step? The answer could be deploying a Laboratory Information Management System (LIMS). If you are wondering why let’s spend a little time considering the test workflow.

The classic workflow will look something like this:

1. A sample is submitted
2. It is received into the Quality Control laboratory
3. The tests to be performed on the sample are determined and allocated to the sample
4. Tests are completed and results are noted
5. The results are validated and approved
6. Some form of certificate is produced to confirm that the sample has passed or failed the test. This is used to determine whether or not the batch can be released.

If we scrutinise the workflow it becomes apparent that the CDS is used for a small proportion of the process - testing the sample and entering results. Using a validated CDS is an excellent way to ensure Data Integrity for this part of the workflow.

But what about the rest?

Is this where LIMS can help? A well designed LIMS will interface with your CDS and importantly will ensure that the whole, not just part of, the process is handled in a regulatory compliant manner.

You now may be asking how it does this? By selecting a well-designed LIMS aligned to regulated markets you will ensure that:

• Individual users have their own password protected sign on.
• The audit trail will capture who does what and when. Data cannot be modified without being captured in the audit trail.
• Actions will be captured in the audit trail as they happen.
• Electronic signatures are in place. The stamp that confirms who entered the data and a major part of the FDA 21 CFR part 11 regulations.
• Permissions are allocated to ensure that only correctly trained personnel are able to perform a particular task.
• Calculations from test results are verified – no incorrect calculations.
• Test data is checked by a second individual to ensure accuracy and completeness.
• Data trending is performed in a secure environment - no more issues with trending within excel and the possibility that data is changed with no record as to how, when and why.
• Test data is backed up.

In other words, the whole sample test process is now operating in a regulatory compliant manner.

Imagine attempting to achieve all of this with manual systems. With the ever-increasing regulatory requirements the challenges are sure to grow so now could be the time to help yourself, your team and your business by moving your systems to the next level.

In summary, validated CDS combined with a validated LIMS will give you the confidence that the whole process meets the regulatory bodies’ requirements ensuring that your next inspection is a success. It will also simplify your systems and generate efficiencies.

Are you reaching the conclusion that a validated CDS is part of, but not the total Quality journey? Is now the time to investigate how LIMS software can help?

The team at Broughton Software are here to help. LabHQ LIMS has been developed with regulatory compliance at the top of the agenda. We would be delighted to hear from you, learn more about your challenges and investigate how we can help.