Validating Processes

All laboratory equipment used for drug discovery, analytical methods use and routine manufacturing support must be validated in order to comply with Good Laboratory Practice (GLP), a set of industry guidance and regulations that are constantly changing. In busy laboratory environments, dealing with the large amount of documentation related to validation processes can be challenging. It is therefore important for organizations to implement tools for managing these validation activities. Although these tools can vary from site to site, many large organizations are now looking at standardizing validation project management. Such tools offer efficiency gains to smaller, resource-limited organizations as well.

The methods used to manage validation projects vary widely across the life sciences industry and even within the same company, depending on the style of individual project managers. There are several stages in validating equipment, and having several methods of managing validation projects can be time consuming and cause confusion within an organization. Some laboratories change equipment and therefore validation processes regularly, which over time can prove more costly and less efficient than having a standard validation project management system in place to ensure that existing equipment is re-validated at set intervals.

Traditional data and document management methods

Historically, multiple validation tools have been used to manage validation projects and documents. These include creating individual templates in a word processing package for each piece of equipment or system, creating a specific document for that particular project and circulating the document via email as well as using File Manager and printed paper documents for review and approval. E-mails can be difficult to track, with complex documents taking up a lot of electronic storage, and can easily be lost when sent to numerous recipients, which means that project managers are not always accessing the most up-todate information. Paper documents can also be misplaced, old versions not destroyed or shredded, and document versions unable to be easily tracked without cumbersome management systems. Furthermore, a significant amount of physical space and human activity is needed to store, manage and archive these documents. Such methods can lead to inconsistencies and errors, which means that projects rarely meet the validation and regulation requirements within the time frame or budget. Larger companies have had the luxury of being able to throw resources at the problem. But with the increased number of resourcelimited SMEs (Small Medium sized Enterprises) operating in the same space and the need for larger corporate departments to address costs, laboratories are beginning to incorporate computer-based validation management tools that are capable of managing the whole project lifecycle.

Regulatory requirements

There are a number of regulations relating to the validation of systems and equipment as well as the storage of electronic documents. The GLP guidelines deal with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. These specify that all equipment must be periodically validated to ensure accuracy, reliability and consistency, which influence the validity and quality of test data.1 Laboratories required to follow the guidelines produce significantly more documentation than laboratories that do not and must be able to store, retrieve and trace all data, even long after the project has finished. This audit trail is critical to the regulators, and indeed life science customers of contract laboratories.

Organizations dealing with electronic documents and records must comply with FDA 21 CFR Part 11 guidelines, which define the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. The electronic records must be securely stored in a controlledaccess environment and tracked throughout the document’s entire lifecycle. This includes storing clear audit trails and version histories so each individual document can be followed from creation to archiving and recalled if needed many years from its creation by project managers— tasks that are difficult and costly when using File Manager and email-based document management methods or, worse, paper records.

Emerging technologies

To address the common problems and costs associated with traditional validation projects, Good Products has developed ValMan™, a simple and complete validation project management tool designed to streamline validation projects in one easy-to-use package. The software allows documents and activities for specific validation projects to be stored in separate secure areas. A set of predetermined workflow templates facilitate effective project management. They allow document reviews and approvals by third parties not on the client network, with full audit traceability, template management and user management. Users have access to a database of some 15,000 templates from a variety of equipment, systems and facilities validation projects, including Validation Master Plans (VMP), Validation Plans (VP), Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) protocols. The software also allows users to adapt and input their existing document and validation work flows and processes into the system for greater efficiency, as well as use any global templates or document templates already developed.

The ValMan module sits on the g-docs™ GLP 21 CFR Part 11 compliant platform from Good Products and allows users to store electronic documents in one secure area with full tracking of the document, including version history. Using the software, laboratory workers can be assured that their computer systems, equipment and analytical method validation projects are fully compliant at all times. ValMan is easy to install and is easy to use as it is based on Microsoft systems regularly used by laboratory staff. Project managers can easily configure the software to allow access to data libraries for individual users depending on their job title, job description and their level of responsibility, without the need to utilize additional programs. All customers benefit from complimentary unlimited training for users and administrators and the software can be integrated into Outlook where re-validation dates, document approvals, and project changes can be notified via email, prompting user action.

Conclusion

Using a designed validation project management tool offers laboratories a standard and uniform method of managing all validation projects, documentation and data by eliminating the need for multiple computer systems. By storing all validation artefacts in one secure repository, companies can benefit from standardized validation projects, best practice proliferation across the group and be confident that all projects are fully compliant with industry regulations and guidance. Such secure systems are easy to use and can be swiftly implemented to increase efficiencies in validation projects, thus saving time and costs over traditional validation processes.

1. http://www.labcompliance.com/tutorial/glp/default.aspx