Using non-ERES Compliant Business Intelligence Tools in Support of GxP Decision Making

Another interesting question here - this time posted in the LinkedIn 21 CFR Part 11 discussion group on the use of business intelligence tools to support GxP decision making,. However, the business intelligence tools are not 21 CFR Part 11 compliant!

Q. We are implementing a 'system' which comprises of replicating software from Oracle and a destination replicated Oracle database. The purpose of this 'system' will be for running Oracle and Cognos reports from this replicated database instead of the high transactional source database. This system will be accessed only by the DBA.

The replicating software is pretty much command line based which is basically to say it does not have a GUI. From the command prompt user interface of this software, we can define (enter commands) for the source and target database; define the number of processes to run; set filters for what data are to be replicated and the frequencey for replication.

We did an assessment and found that part 11 is applicable. The problem is that we cannot satisfy all the part 11 requirements.

Although we deal with e-records (store the data from the source system including setup/ configuration of replication process) how do we still justify that e-signatures, audit trail requirements or password aging/restrictions are not applicable and not supported by the replicating software?

A. We've just finished doing exactly this for another project where we set up a reporting database to reduce the load on the transactional system. Some of the reports from the data warehouse were GxP significant.

 

We also had similar issues consolidating medical device traceability data for the device history record from signed records in SAP to the SAP Business Warehouse (BW) where we lost the secure relationship between the signed records in the transactional database and the copy in BW.

 

It's all about clearly identifying what records and data are used for what purposes, documenting the rationale and design, developing or updating appropriate SOPs and training your users and DBAs accordingly.

 

The first thing to do is to clearly differentiate between the records that you will ultimately rely on for regulatory purposes versus the data that you use for reporting. We maintained (and clearly documented) that the signed records in the transactional system would always be the ultimate source of data for regulatory decision-making (i.e. product recall, CAPA investigations etc). Where applicable these were signed and could be verified and were still Part 11 compliant.

 

Our rationale was that the data warehouse (and associated GxP reports) were acting as a grand 'indexing system' which allowed us to find the key regulatory records much faster (which has to be good for patient safety). We would not use these reports for making regulatory critical decisions, but we did use these reports to be able to more quickly find the key records in the transactional database which we could then rely upon for regulatory decision-making. Under that rationale the records and signatures which was subject to Part 11 remained in the transactional database.

 

We made sure that SOPs for key processes such as product recall, CAPA investigation etc were updated to reflect the appropriate use of the reports and the signed transactional records. We were able to demonstrate that using the data warehouse reports was between 2 to 3 times faster than running queries and filters in the transactional system and we could find the records much faster. In our testing we were also able to demonstrate that we always found the correct record (more than 99.9% of the time) unless something had subsequently been changed in the transactional database (less than 0.1% of the time) and even where this was the case the discrepancy was obvious and would not lead to erroneous decision-making.
 

However, that's not to say that the GxP significant reports were not important. We still validated the software which replicated the databases, we qualified the underlying IT infrastructure and we validated the GxP significant reports.

 

We essentially had three categories of report:

• Non-GxP reports, which were not validated (this was the majority of reports)
•  GxP significant reports, which were not based upon signed copies of Part 11 records, but which were validated.
• GxP significant reports, which were based upon signed copies of Part 11 records help in the transactional system.These were validated and were clearly annotated to the effect that they should not be relied upon for regulatory decision-making and they also gave a reference to the signed, transactional record in the transactional database.

 

On both of these projects we had much better tools for the replication of the data. Since you're using Oracle databases we would recommend that you create (and maintained under change control/configuration management) PL SQL programs to replicate the data bases. This will significantly reduce the likelihood of human error, allow you to replicate the databases on a scheduled basis and make it much easier to validate replication process.

 

For more background (discussion paper and webcast) on the use of validated Business Intelligence tools for GxP decision making on our website at http://www.businessdecision-lifesciences.com/2297-operational-analytics-in-life-sciences.htm.

Integrated ERP and CRM in Life Sciences

As many of you all know, over the last few weeks we've organized a couple of webcasts looking at the integration of ERP and CRM systems ("Leverage Your ERP & CRM Data to Make Faster, Smarter Decisions" and "How To Integrate Product, Customer and Patient Data"). This is as part of a series of five webcasts we are running related to enterprise systems.

The last two webcasts have looked not only at the advantages of integrating ERP and CRM systems, but also the use of master data management, business process orchestration and business intelligence tools.

There are some good questions the came out of yesterday's webcast session and unfortunately we didn't have time to answer them all during the live webcast. 

As we promised we've reproduce the unanswered questions and our answers here our blog.

Q. Can you say more about why some life sciences companies are keen to get into healthcare management and what they are doing?

A. We talked about this quite extensively in one about earlier webcasts () but basically were seeing a number of life sciences companies move more into healthcare as they see their traditional profit margins being increasingly squeezed. Moving into healthcare has several advantages such as:

• Opening sources of new revenue
• Ensuring better health outcomes for patients

In the case of this latter benefit this means that patients are more likely to continue using the regulated companies drugs or devices, thereby ensuring an on-going revenue stream. At a time when many payers (whether these are insurers or governments) are increasingly looking to pay based upon results it makes sense for life sciences companies to ensure that patients are complying with their medication regimes and treatment is successful.

In the case of yesterday's webcast were seeing a number of life sciences companies increasingly extend the use of their CRM systems to incorporate the use of patient and healthcare management.

Q. Can aggregate spend reporting be built into CRM systems?

A. It is certainly possible to build aggregate spend reporting based upon information that is held in CRM systems. For small to medium life sciences companies with only a single CRM system, these systems may indeed contain all of the information required to produce accurate aggregate spend reports. However, where there are multiple CRM systems data usually needs to be aggregated across the systems and as we saw yesterday's webcast there are also advantages in terms of integrating information from the ERP system such as cost information and expense data.

For those of you specifically interested in this topic we'll be talking more about aggregate spend in a webcast in the New Year

Q. With such a focus on external patient facing activities, easy ERP system becoming less important?

A. The traditional reasons for implementing ERP systems have never gone away. Those of us remember the days of early MRP and MRPII implementations understand the significant benefits that such functionality brings. For small to medium life sciences companies who do not currently leveraging ERP system there is considerable return on investment from implementing core ERP functionality. This should really be the primary reason for acquiring and implementing a new ERP system.

However, we are seeing ERP systems become increasingly integrated across the enterprise and not just in areas such as manufacturing and operations. While ERP systems are just as important as ever, they are becoming more and more integrated into the enterprise applications landscape.

For a company that has no ERP system implementation of a new ERP system is properly one of the most important things the company can do in terms of investment in IT. However once the basic ERP functionality has been implemented there are a number of additional end to end business processes that can be facilitated by integration of the ERP system and it is perhaps true to say that additional manufacturing functionality may not be the most important extension of functionality.

If you have any remaining questions please do get in touch and for those of you who missed the webcasts the recordings are still available on the Business and Decision Life Sciences website (see Past Events). We do hope you'll be available for the rest of the webcasts where we were looking at some interesting topics such as

• How to leveraged software and system integration activities for cost effective validation
• How to integrate good record-keeping and document management with your ERP and CRM systems
• How to plan for successful ERP and CRM systems as a regulated company

Answers to Webcast Questions - Compliant Business Intelligence and Analytics in Life Sciences

Thank you to everyone who attended the webcast "Compliant Business Intelligence and Analytics" and who submitted questions. The recording is now on-line and subscribers can download the slides from the Business & Decision Life Sciences website via the Client Hub.
Listed below are the questions that we didn't have time for in the live webcast, along with the answers we promised to provide.


Q. How could BI be beneficial in an IT industry "IT Project"?
A. IT projects and processes are another subset of business processes and Business Intelligence and Analytics can certainly be applied there. The use of Key Performance Indicators in IT Projects and Processes was covered extensively in our webcast "Measuring IS Compliance Key Performance Indicators". This includes the use of Business Intelligence applications for supporting project and process improvement, both in terms of efficiency and cost effectiveness and also in terms of regulatory compliance.

Q. How would you qualify a BI solution provider (if one ever needed to be hired for a project)?
A. No differently from qualifying any other vendor. We would focus on the maturity of the solution provider in terms of:
- Track record in Business Intelligence (do they know the specific technology/application, can they help develop a BI strategy and architect a BI solution?).
- Track record in Life Sciences (and in the particular business domain [e.g. clinical trials versus sales and marketing] and the particular sector [e.g. pharmaceuticals, medical devices, biomedical etc].
Assuming that a BI solution had already been selected we would also look to the BI vendors to make recommendations with respect to which solution provider they would recommend.
When combined, these factors would reduce a list of potential suppliers to a manageable number.

Supplier selection seems to be a question that has been asked a few times in various webcasts and is something we'll look at covering in more detail in a future webcast.
Thanks again for joining us for the webcast and if there are any follow up questions you can submit them via the Life Sciences website