| Joint or cooperative software development is by no means a new phenomenon. Indeed, in the chemical and pharmaceutical industry, there is a long history of IT customers working successfully with vendors, particularly in the specification of customized software to suit a customer's specific working procedures. However, such an approach can have its drawbacks. If bespoke development moves too far away from the core product functionality, then the single customer is in danger of feeling isolated from the rest of the user community and unable to benefit from, for example, shared experiences. A group of German pharmaceutical companies using the same Laboratory Information Management Systems (LIMS) got together in 1997 to use its collective influence to identify new functionality based on common requirements. This community is called TABAK.
TABAK is a unique community of LIMS project leaders, whose name derives from the five German pharmaceutical companies which formed it:
- Thomae (Dr. Karl Thomae GmbH, since 1998 Boehringer Ingelheim Pharma KG)
- ASTA Medica AG
- Boehringer Ingelheim Pharma KG
- Arzneimittelwerk Dresden GmbH
- Knoll AG.
Members of the TABAK community all use the enterprise LIMS - SampleManager™from Thermo LabSystems. At a SampleManager User Group Meeting In 1997, all five companies' project leaders were attendees and all found their organizations were at a similar phase of implementation. Additionally, all five found their implementations were being coordinated by the same Thermo LabSystems project manager.
In informal discussions between the members prior to TABAK's formation, it became clear that, although there was general satisfaction with the decision to select SampleManager, there was broad agreement that the LIMS lacked some functionality in areas required by the pharmaceutical industry. For all these reasons, TABAK was established to work jointly with the vendor (Thermo LabSystems) to specify and implement new modules and functionality for SampleManager.
This scope of the TABAK project covered the following:
- Identification of required new functionality
- Definition of common requirements
- Determination of priorities
- Specification
- Coding and implementation
- Testing and release
Though the selection process for a LIMS took place before TABAK's formation, it was found to be very similar across the five companies. Many LIMS users, particularly within the same industry, share similar selection criteria. Improved productivity is a major issue. A large percentage of labor time in chemical-analytical laboratories is occupied by non-creative data processing operations. This is partly due to the sheer volume of information that requires managing within a modern automated laboratory. Weak points include the interfaces, routine evaluations, archiving and administration of data, and reporting.
- The selection phase including the following steps:
- Preparation of a requirement document
- An assessment of available LIMS solutions/vendors
- Invitation to tender
- Evaluation of the responses, offers, submissions
- Vendor selection
- Test installation
- Confirmation of the decision
- User requirement specification
Two aspects of the project which best demonstrate the benefits of TABAK's collaboration were Validation and Documentation.
1. Validation
Early in the course of the TABAK project, a decision was made to jointly prepare a common set of validation documentation for the system. The group benefited from its collective past experience in validating systems and made significant savings by specializing in individual and/or related activities. As the system was to be used in GLP/GMP environments, there is a requirement for it to be validated to satisfy the various regulatory authorities by demonstrating compliance.
In software development, upgraded modules or those newly released by the programmers have to be tested by the customer. This requires the setting up of a development system and a system used for testing. For validation purposes the modified system with all its changes is re-installed, validated and used as the production system. The test and development system are retained and used as the basis for further development. Once the validation scope was decided upon, the project included:
Development of a risk analysis
The risk analysis identified and categorized quality-related functions.
All standard functions in SampleManager were tested by Thermo LabSystems, so TABAK did not conduct Operational Qualification (OQ) testing for these. An exception was made during the Performance Qualification (PQ) and some standard functionality in the work flow was tested. All new functions specified by Thermo LabSystems were tested in the OQ tests.
Vendor audit
A major benefit of the single validation project was the joint vendor/software quality audit at Thermo LabSystems' offices. Each company had a representative of their QM department on the audit team.
Development of the Operational Qualification and the OQ-Tests
After identifying areas of critical functionality, TABAK created test cases for OQ; a vital phase in the system validation process. Within the scope of OQ, the study workflow and the sample life-cycle were also tested.
Members agreed the layout and the criteria to pass the tests. For each quality-related function which were defined as "high", an OQ test was created as identified in the risk analysis.
2.Project Documentation
Project documentation plays a crucial role in application development, particularly in a heavily regulated environment such as pharmaceuticals where the solution has to be validated. Management of these documents during development can be very time consuming and complex. Requirements like change control and authorization procedures can add a great deal of administrative work to the day to day business of software development.
Taking advantage of the TABAK members' experience and the good practice of the represented companies, a hierarchical program structure of document management was designed. This involved a strategic implementation partner of Thermo LabSystems, Uptodata, based in Germany. This helped TABAK considerably in the management of the increasing number of documents created during the project lifetime. The program, based on a Lotus Notes database and including an Explorer-type graphical interface, handled:
- Document versions and their status
- Conventions for release numbering
- Releases and history of versions
- Project phases
- Subsystems and modules
There were four main areas of new SampleManager functionality that resulted from TABAK's collaboration with Thermo LabSystems. These were:
- Spreadsheet result entry – This facilitates result entry and review in a matrix format. This is particularly useful in dissolution testing.
- Purity test result handling – Functionality for the handling and calculating levels of known and unknown impurities.
- Dissolution testing sub-module – Dissolution testing is a common methodology in pharmaceutical development. This module allows the entry and reporting of dissolution testing results.
- Automated creation of stability reports - A facility for specifying the layout and formatting of reports for stability testing.
The TABAK group's experiences in successfully collaborating with a LIMS vendor to meet common requirements for enhanced functionality could well set a trend in future scientific application development. There were clear benefits in the ‘
'strength in numbers' and a community spirit developed which had benefits beyond the original purpose of TABAK's foundation. All five laboratories have now gone live with the new modules and are benefiting from the results of their cooperation. The advantages of this type of initiative to the vendor, Thermo LabSystems, should also not be underestimated. Thermo LabSystems was presented with an industry wide view of the pharmaceutical industry's requirements, rather than having to specify customization of SampleManager for the five individual companies. This meant that Thermo LabSystems were able to deliver the right solution once for a handful of customers and has resulted in a LIMS that meets more precisely the demanding requirements of the pharmaceutical industry.
* A German language version of this article appeared in the journal Chemie Plus, November 2000 edition.
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