QA/QC Insight: If it’s on paper…where is it?

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No matter what industry you work in, your laboratory faces some combination of legal, regulatory or corporate requirements to provide secure and on-going access to the data and documents that support your test results.

At any time, a customer audit, a corporate audit, a regulatory investigation or even a legal proceeding, may require that you show on a step-by-step basis how a result was determined and prove that the result you reported is indeed the correct result.  That can be a challenge when your data and supporting documents are on paper.

A study conducted by Price Waterhouse clearly illustrates how difficult that can be.

The study asked a staff of paralegals to search over 10,000 documents, looking for a specific topic, author and date range. Manually searching through paper files took 67 hours (almost 3 days) and turned up 15 documents. The same search, done electronically, found 20 documents in only 4.5 seconds - about as long as it takes to read this sentence.

That points out two critical concerns for every laboratory with paper-based systems:

   1. The amount of time it takes to manually search for documents. When people are waiting for answers you don’t want to keep them waiting while you try to track down a piece of paper.

   2. The likelihood that key documentation may not be found in a manual search. In the study, 25% (5 out of 20) of the documents that met the search criteria were not found in the manual search.

The supporting documentation for even a single sample can include instrument results, calibration information, solution preparation procedures, certificates of analysis for raw materials and more. It isn’t uncommon for the documentation for a single test to run into dozens of pages.

In a paper-based system, accessing those documents can mean having to manually search through forms that have been put away in filing cabinets, stacked in boxes in a storage room or even sent to an offsite storage location. And that needs to be done as quickly and accurately as possible.

In a paperless lab where documents are stored electronically, you can very quickly and accurately identify and retrieve all of the documentation that you need in order to resolve problems or to satisfy auditors and investigators. No more time wasted searching for pieces of paper that you may never find.

For more insight into eliminating the costs and risks of paper based systems in the laboratory, watch our full length presentation “The Paperless Lab – More than a Vision”.

QA/QC Insight: Reduce data review time without compromising quality

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One of the key challenges we see QA/QC laboratories facing is the need to increase sample throughput and improve turnaround times without increasing the cost of analysis.

An effective way to meet this challenge is to reduce the amount of time spent on data review. Lab personnel that spend less time on data review have more time to spend on sample analysis. Reducing data review time also reduces turnaround time, getting results out to clients and end users faster.

However, reducing data review time cannot in any way reduce confidence in the quality, accuracy and consistency of reported results.

Let’s look at two steps that a lab can take to reduce data review time without compromising data quality.

Step 1 – Eliminate Paper

The first step to reducing data review times is to eliminate paper based processes for data collection, test execution, reporting of results and management of laboratory resources.

Every time a manual entry needs to be made in a paper based system, it creates a potential source of error that needs to be reviewed – recording sample information, recording test results, performing calculations to arrive at final results, recording instruments that are used or lot numbers of reagents and materials  – the list goes on and on. A thorough data review process requires taking the time to review and confirm the accuracy of each of these manual entries.

The review process can be further delayed by the reviewer having to:

- Resolve illegible entries “Is that an 8 or a 3?”

- Locate lost or misplaced records “Where is the second page for this test?”

- Verify the testing process “Was that reagent still within its expiry date? I better go and check the inventory log. “

Moving away from paper based systems reduces the potential points of error that reviewers need to focus on and provides faster access to the information they need to carry out a thorough review.

Step 2 – Bench Level Control over Test Execution

Most laboratories have recognized the drawbacks of paper and have taken steps to move away from paper-based processes. Spreadsheets are used for recording test results and performing calibrations. Applications for inventory and calibration are seen as a step forward from paper log books.

However, every one of these stand-alone solutions shares a common problem. They don’t know anything about how the analysis is performed. Did the analyst record the data correctly, did they look up the expiry date for that reagent and did they check that instrument’s calibration before running the test? So the reviewer has to look through each of those different applications to answer all of those questions. And that takes time.

A better approach is to answer all of those questions at the time of analysis by integrating all of the different applications in a way that allows them to share information in real time and use that information to control test execution at the bench level. A Laboratory Execution System (LES) provides just that capability.

Within an LES, an electronic worksheet can automatically check with a calibration application to make sure that the instrument being used is calibrated before the sample is tested. It can check with the inventory application to make sure the reagent hasn’t expired before the analyst uses it. It can take control over execution of the SOP at the bench level, guiding your analyst through each step of the process.

Knowing that all of these checks take place as a test is run reduces the amount of time spent on data review without compromising the quality of the data that is being reported. 

More Information

Watch a short video demonstrating how iLAB LES and the Ensemble® for QA/QC platform help laboratories work more efficiently, driving productivity while maintaining accuracy and compliance

QA/QC Insight: Integrating the lab with SAP®, Part 2

In Part One of this series, I talked about how a simple, direct integration between the laboratory and SAP® can be a cost effective solution for automating the transfer of test results from laboratory instruments to SAP/SAP QM (Quality Management). If that integration is also able to perform additional processing on the data it can eliminate the cost and effort required to implement laboratory specific calculations and processing in SAP.

In Part Two, I’d like to consider a fuller integration between SAP and the laboratory and see how it can open up opportunities to enhance laboratory processes by adding new levels of automation and control at the bench level.

Fuller Integration to the Lab Bench Level

This approach supplements the functionality of SAP with a Laboratory Execution System (LES) that provides the lab with bench level automation, control and documentation of their day-to-day test execution. For laboratories that haven’t already implemented a LIMS or are considering changing their LIMS, this can be the solution that delivers the best value in terms of operational efficiency and productivity.

An LES provides a structured platform that eliminates paper while automating and controlling testing procedures at the bench level. Sample information, test execution, inventory control and instrument calibration can all be integrated to ensure that procedures are always followed and to automate the flow of information. The laboratory is able to operate more efficiently as errors are reduced, less time is spent on review and rework, and information is readily accessible when needed.

SAP/SAP QM can be integrated with an LES to provide a high level of interaction with the laboratory.

·         Use triggers from SAP to initiate test execution in the LES

·         Transfer data from SAP to populate electronic worksheets in the LES, reducing workload for analysts

·         Integrate the LES with other informatics systems and applications to automate and control test execution

·         Perform calculations and data approvals in the LES prior to reporting to SAP

·         Transfer results automatically from the LES to SAP

Integration between SAP and an LES can enhance and improve laboratory processes – opening the door to faster sample turnaround and increased sample throughput. Laboratories can gain control over their day-to-day operations without the need to realize the cost and complexity generally associated with the deployment of a full-blown LIMS.

OF INTEREST:  “Connecting the Laboratory with SAP” is a short video that demonstrates an automated integration between SAP and an LES.

SAP and SAP QM are registered trademarks of SAP AG in Germany and in several other countries

QA/QC Insight: Integrating the lab with SAP®, Part 1

"QA/QC Insight" will be a blog series authored by Steve Bolton, Marketing Program Manager for the Ensemble for QA/QC informatics platform at PerkinElmer Informatics. Steve has over 20 years of experience in the field of laboratory informatics with a focus on applications for the QA/QC lab. During that time he has experienced the evolution and revolution of laboratory informatics from DOS prompt commands to web based, integrated systems and mobile apps.

Over the years I’ve seen organizations discover real value by providing close integration between their QA/QC laboratories and SAP® Quality Management (QM) software.

In almost all cases, integration between the lab and SAP opens up opportunities to:

·         Further leverage investment in SAP

·         Consolidate technologies and reduce IT costs by using SAP QM to replace LIMS

·         Ensure timely, accurate delivery of data into SAP QM in order to support decision making in the manufacturing process

However, there can often be a reluctance to start up a project like this as there can be real concerns around the complexity, cost and time involved. In the laboratory, there can be apprehensions about losing efficiency along with losing flexibility and control over their processes

In this two part series I’ll look at two approaches to SAP QM integration that address these concerns. I’ll start by considering a simple integration that connects instruments and data systems directly with SAP QM.

Simple, Direct Integration with SAP QM

At its most basic level, integration can simply be a matter of transferring results from instruments and data systems into SAP QM. The process should be as transparent as possible for lab technicians so that it doesn’t get in the way of their workflow and reduce their efficiency.

Ideally, the solution should also be a “universal connector” that can collect data from any type of instrument or data system. Having a single “connector” that can be configured to work with each instrument in the lab will help to reduce the time, effort and cost of implementation and maintenance.

With the right tool, even a simple, direct integration can be used to automate some routine, manual tasks in the laboratory.

·         Calculations that need to be performed before the data goes to SAP can be automated within the interface to ensure that they are done consistently and accurately every time.

·         Worklists can be collected from SAP and used to map test results from the instrument with samples as they are stored in SAP.

·         Limit checks can be performed to identify Out-of-Specification test results before reporting to SAP

A simple, direct interface with SAP can be a cost effective solution for automating the transfer of test results from laboratory instruments to SAP QM. Choosing a configurable solution with additional power for processing of data can eliminate the cost and effort required to implement laboratory specific calculations and processing in SAP®.

In Part 2 I will investigate how a fuller integration between SAP and the laboratory can open up opportunities to enhance laboratory processes by adding new levels of automation and control at the bench level.

OF INTEREST: Connector for SAP a simple direct interface between SAP and the laboratory.

SAP and SAP QM are registered trademarks of SAP AG in Germany and in several other countries