The use of office documents like Word and Excel spreadsheets is widespread in the pharmaceutical companies. The 21 CRF Part 11 requirements demand that where necessary strict controls apply to those documents used for critical data. Here, Freek Varossieau looks at Excel spreadsheets and how to bring these in compliance.
The use of Office documents like MS-Word and in particular Excel has been growing extensively in the scientific community. The power of eg Excel in processing data and displaying the results is well-known, but compliance to 21 CFR Part 11 (21/11) remains cumbersome. Yet compliance is a must in the pharmaceutical arena.
The development of Excel template is often done by specific users. Validation and approval of these templates are a pre-requisite to compliance. How to ensure that others use the correct and most current templates and how to ensure that these processed spreadsheets are stored in a secured location? This is a daunting challenge that has only recently addressed with new software packages.
A number of activities involving spreadsheets are development, reviewing, validating and approving. After approval, users need access to spreadsheets without having the ability to modify or overwrite the stored templates. Furthermore, activities of users need to be logged in an audit trail.
Next to audit trail, version control on stored records is of paramount importance. It protects previous loaded spreadsheet from overwriting and allows an immediate roll-back when necessary.
Key factor for success is access control. A good application allows organisations to map their workflow to a data structure. Within this data structure access to data must be controlled. With a single logon users can have multiple job types enabling them to perform multiple tasks. Access control combined with versioning and audit trail safeguards the stored records within the 21 CFR Part 11 guidelines.
One of the software solutions providing compliance is the Scientific Software CyberLAB Knowledge Engineering System. Combined with the CyberLAB Desktop application it provides access from the Excel application to the secured CyberLAB repository. It allows developers to create, manage, validate and publish Excel spreadsheets, as well as other Office documents like SOPas. No special knowledge of the CyberLAB application is needed for the end user. The user will stay in its familiar Office environment for retrieving and storing spreadsheets and documents.
The functionality of CyberLAB is tuned to offer a fine grid of access rights and job types through the unique Location Cabinet Drawer Folder (LCDF) principle. In one tree of this structure a user can access and retrieve templates, but not overwriting them. In another tree the user can stored the processed sheets in the secured CyberLAB environment. Complete version control protects previous spreadsheets from being overwritten and add traceability to spreadsheet changes.
Completed spreadsheets can be published in the common PDF format and shared with other users in the organisation. Information can be retrieved from these spreadsheets and re-used as data source for other applications or documents. A traceable link to the PDF report is maintained and allows immediate access to the original data.
The access to the stored spreadsheets is governed by the CyberLAB application and integrates with the Office environment. In Fig. 1 and 2 depicts how users work on a routinely basis with the CyberLAB Desktop. Fig. 2 shows how to browse for records stored in the CyberLAB repository. Users can search the entire system for records stored and access these. With CyberLAB Desktop's database architecture, you can search for documents and files based upon their content directly from your office application. You can search for file based on single words, phrases or a combination of words using Boolean operators. Once located, you can open the file of interest into your office application with a single click.
Although electronic signatures are not mandatory for Part 11 compliance, the use of it assists in the workflow management and release of spreadsheets. The CyberLAB application brings full electronic signatures to spreadsheets. It is used to control the reviewing and approving of spreadsheets and supports the validation process. Approved and release spreadsheets are published and users are only exposed to the latest and valid version of a spreadsheet. Once stored, the filled spreadsheets can be electronically signed by the users. Spreadsheets converted to the common PDF format can be signed and published to the enterprise. In Fig. 3 a signed PDF document is displayed.
CyberLAB Desktop is a new way to manage Microsoft Office and Adobe PDF files. Through the integration of these software packages and CyberLAB Knowledge Engineering System, you now have a single, secure repository for enterprise documents and spreadsheets. With CyberLAB, you can store, protect, search, warehouse, retrieve and archive any electronic record.
Enter 74 or at www.scientistlive.com/elab
Freek Varossieau is with Scientific Software International BV, Willemstad, The Netherlands. www.scisw.com
