Outsourcing Laboratory Work—Establishing the Necessary Policies and Practices

BioPharm International, BioPharm International-04-02-2008, Volume 2008 Supplement, Issue 4
Pages: 40–45

The outsourced service provider should be considered an extension of your own laboratory.

Outsourcing can provide a laboratory with an expanded range of options and tools to conduct its work. Those options can reduce operating costs, allow a laboratory to take advantage of techniques that might not otherwise be available, cross-check results, handle an unusual surge in samples, and develop automation systems. This is particularly true for laboratories that provide analytical or physical property testing support for process development or quality control. 

To use outside services effectively, the laboratory must understand the way it functions and how it will manage the outsourced services and the results of its work. Whether the outsourced company provides testing, method development support, or hardware and software systems design and implementation, it should be considered as an extension of a laboratory. 

In a regulated environment, the laboratory is responsible for the quality and conduct of its suppliers. The contract service organization is in effect a virtual laboratory, subject to all of the requirements that your laboratory has to meet, including validation and regulatory requirements. This article discusses some of the considerations in outsourcing laboratory testing, method development, and the design of automation systems.

Outsourcing Testing Operations

In many respects, testing operations are similar to manufacturing operations. Samples are processed according to well-defined procedures, and information (e.g., test results, the end product of a testing laboratory's work) are recorded and sent to the customer (R&D, process development, process control, etc.). Thinking about a laboratory in that sense allows us to model outsourcing operations in much the same way a manufacturing plant outsources parts of its operations, with the same considerations for quality management and regulatory issues.

When selecting an outside laboratory to conduct analytical tests, the following need to be considered:

1. Does the contract laboratory have experience with the types of materials and test methods it will be using?

2. How will you ensure confidentially of test methods and the results of the work?

3. How will the laboratory's employees be trained to handle your project?

4. What procedures will be put in place to check the quality of work? How will discrepancies be addressed?

5. What validation protocol will be used to support the outsourcing program?

6. What equipment will be used to conduct the testing?

7. How will the results of the work be reported? What formats will be used?

The first five questions mentioned above should be outlined in the contract between your laboratory and the provider. The final two items are not as easily defined because they rely on automated systems for data acquisition and analysis. For example, let's assume that the test procedure is an assay using liquid chromatography (Figure 1). The instrument is connected to a data station that acquires, processes, and stores the data in a laboratory information management system (LIMS). Your laboratory's systems are from XYZ company, and the format of the data in the data station is unique to XYZ as are the methods used to analyze the data. If you and the contract service organization use incompatible equipment, your test results data also will be incompatible. It may not be possible to reevaluate results from the acquired data and you may have to repeat the analysis, unless manual calculations from reported peak parameters are acceptable. Having an agreement with the contractor to maintain the data on its systems and provide you with a copy can mitigate this situation. Keep in mind, however, that the data lifecycle may be decades, and you can't be sure that the contractor will be in business that long or that its archiving systems are adequate.

 

The Process Flow Model

Understanding how a laboratory's workflow takes place, where data comes from, how information is processed and stored, and how data is entered into the LIMS, will give you a basis for deciding how the results of testing from an outsourced testing services can be integrated into your laboratory's systems. Figure 2 shows the workflow in a testing laboratory along with the entry points for test results and new analytical protocols. The ovals represent databases and the arrows are processes used to carry out a stage in the test protocol. Starting at the top, a document management system contains test method protocols and supporting documents (hazardous materials, etc.). Test methods are implemented in the measurements and experiments process and would include sample preparation and chromatographic work in Figure 1. All of the steps in Figure 1's chromatographic data station are shown in the grey box in Figure 2 as the detector signal is measured and stored in the instrument data set. The data stations analysis software processes the chromatographic data and the result is entered into the LIMS. Data and results from external sources (ES) can enter the system in three places, allowing outsourced laboratory work and method development to be integrated into the laboratory's operations.

A comparison of Figure 1 and Figure 2 shows:

1. Analysis protocols would be contained in the knowledge database.

2. The sample preparation, chromatographic separation, and data acquisition steps are part of the measurements and experiments process.

3. The acquired data are stored in the data station's database structure, which would also contain any processed data (peak retention time, size, etc.).

4. The results of the assay are entered into the LIMS.

Other analytical protocols would have their own measurement and experiments processes. Each instrument type would have its own database structure, so that the laboratory's overall instrument data system would comprise several databases, one for each type of instrument.

This chart represents only a basic model workflow. Because the specific steps and flow at each laboratory may vary, it is important for the two laboratories to resolve ahead of time any differences that could pose a problem.

Outsourcing Method Development

The considerations for outsourcing method development work are similar to what we've just discussed. All of the validation and regulatory issues apply to the outsourced company just as they would if the work were done in your own facility. In addition, the following need to be kept in mind:

  • Who owns the test method? Don't assume that simply because you paid for the work you have complete control over the rights to work. Ownership should be defined in the contract.

  • Incorporating the method into your workflow will require training. If those developing the method use equipment that is similar to what you have in the laboratory, but from a different vendor, determine if any systematic differences can affect the results. Does a particular instrument have a difference in sensitivity or control that is critical to the successful implementation of the procedure?

  • Consider how to integrate the testing protocol. Are there any problems integrating the new protocol into your laboratory's workflow, including updates to the LIMS, for keeping track of tests?

  • Hardware and Software: If the new method required the development or modifications of hardware or software, are the rights transferable to you? Is the actual equipment yours or do you have to purchase a duplicate set and re-implement the modifications? Does the company that developed the modifications have plans to convert them into a product? What considerations does your company get for its investment?

Outsourcing Systems Development

When outsourcing systems development, it is essential to know whether the outsourced project is a completely new development or a modification to an existing software. A successful automation project should include the following:

 

 

The Project Plan: Define the purpose of the project, what the expected end result will be, statements of ownership, acceptance criteria, installation process, warrantee, support agreements, the projected project schedule and cost, and a list of what will be delivered to you (such as hardware, software, source code, documentation, and detailed design documents). There should also be a clear understanding of the impact of the work on any warranties of underlying components. For example, if you are adding software functions to a LIMS or instrument control system, will that void the manufacturer's license, warranty, or support agreements. In addition, there should be an understanding of what will happen if the underlying software is upgraded, if the added functionality breaks or is incompatible with features of the upgraded software, or if changes are required to the installation.

Functional Specification: Describe all functions of the software components, commands, screens, etc. This should be complete so that you can get a feel for how the system will work. You may want to have the users review it to see if there are any process issues.

Design Documentation: A breakdown of the system (hardware/software), how it will function, equipment required, software required for changes (e.g., operating system, compliers, editors), and design revision history. Be sure that the new system is easy enough for engineers to understand and even modify.

Also, the outsourced company should provide a fully documented source code listing and a user manual that describes how to use the software. This is a lot of documentation and will increase the price of the outsourced project, but its purpose is to make sure that everyone understands the new system and to protect your laboratory in case the current developers are no longer available to you.

Ensure upfront that all documents and machine readable code, for example, CD-ROM or DVD, are put in an escrow account to be released to you if the outsourcing provider company stops supporting the product, goes out of business, or does not meet its support obligations. This will also protect you if the software firm is acquired by another company.

Outsourcing projects-from testing, to method and systems development-can be an effective way of extending your laboratory's capabilities. Care should be taken to ensure that the results of these projects can be integrated with the rest of your laboratory's work and, in the case of development programs, be supported and meet regulatory requirements.

Project management will be a mix of managerial and technical issues that can be made simpler by establishing a firm foundation of policies and practices that cover both in-house work as well as contracted programs.

Joe Liscouski is the vice president of technology development at Delphinus, Inc., Groton, MA, 978.448.2836, jliscouski@delphinus-lae.com