WinLIMS For The Pharmaceutical Industry
The production of pharmaceuticals is highly regulated by the FDA, MCA, and other regulatory organisations around the world. Auditing of pharmaceutical companies is carried out on a regular basis to ensure that all areas of the business are adhering to the approved quality procedures. The laboratories and any LIMS in use are subjected to this scrutiny. Hence it is crucial for WinLIMS to provide the tools to meet both the regulatory bodies strict controls and the functionality required by the laboratories. The regulatory adherence tools include. Electronic Signatures (21 CFR Part 11) Extensive Audit Trails High Levels of Security Version Control The laboratory functionality included comprises. Stability Trials
Complaints & Corrective Actions Formulations And more ….. These capabilities, in conjunction with the WinLIMS core functionality, provide a unique solution for the pharmaceutical laboratories without the need for extensive custom code. The benefit of this approach is to reduce cost without sacrificing industry requirements or performance.
Electronic Signatures
Besides assisting compliance with 21 CFR Part 11 WinLIMS provides considerable flexibility in the actual configuration of electronic signatures. It is possible to have electronic signatures on all transactions within WinLIMS however in practice this is not required nor is it a requirement of the regulatory bodies. Therefore it is important to be able to define which current transactions require signatures, and should requirements change, add further transactions. The users can use keyboard entry when asked to confirm an electronic signature, however biometric devices such as fingerprint readers can be used in conjunction with WinLIMS to eliminate keyboard entry.
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Audit Trails
Audit trailing of any changes to data is imperative to pharmaceutical laboratories. WinLIMS allows each laboratory to decide which tables and sub tables they wish to audit trail to meet the requirements of the regulatory bodies. Each audit trail record will contain the data location column name, date changed, changed by, new data value, previous data value and modification reason. A data record can be modified many times; each time a record will be created within the audit trail showing the complete history of the changes made. Beside any data changes being recorded, any deletion of data will also be registered.
Security and Version Controls
Extensive security controls exist within WinLIMS, allowing the granting of privileges to individuals, groups and roles. Once these access rights have been set, the system will record failed login attempts, and can after a number of attempts lock the user account and alert the system manager. Full security tools exist to manage access rights, system logs, forced password renewal, etc. Security is also seamlessly integrated with training and qualifications and as such if a user does not have a qualification for a specific method, that user would not be able to process that method on any sample. Version control of key data is an additional aid to security and adherence to quality procedures. Versioning of specifications and test methods provides controls to ensure the correct use of the current approved specifications and methods. A full history of each version is stored within WinLIMS, enabling the identification of which specification was used by the laboratory to release raw materials and production batches at any time in the past.
Stability Trials
Pharmaceutical products must maintain their effectiveness over time under a variety of different storage conditions. The WinLIMS ‘Shelf-Life Testing option’ allows you to define and apply testing protocols to release and developmental production lots to simplify laboratory sample planning and ensure that all products are properly tested within the acceptable timeframe. Testing protocols define the product that is tested, the userdefined storage conditions, the nominal hold times from the study’s start date, the amount of sample that needs to be reserved for testing, the packaging components and more. To initiate a study simply assign the protocol to the release lot , add any study-specific information, and a series of samples are scheduled for future testing. The scheduling function informs the laboratory when it is time to pull the samples from storage and perform the required testing. As all of the data is stored within a powerful SQL database a wide variety of dayto-day and trend analysis reports are available. These include Current and Future Scheduling, Study Summary (all tests, storage conditions and time points), Intra-Study Trending, Inter-Study Trending, Expiration Estimations, Lab Productivity, Product Conformance, and more.
Formulation Management
WinLIMS Formulations Management includes the ability to define the theoretical formulation for each product. The formulation consists of the planned quantity of each ingredient along with the detailed production steps. When samples are logged against a product its theoretical formulation is automatically associated. The actual amounts of raw materials used, their lot number, supplier, etc. can also be recorded. The actual production information, in conjunction with analytical results, enables careful monitoring and refinement of each manufactured product. Within the QA laboratory the benefit of this approach is to reduce production costs and to maintain high quality standards. For the R&D laboratory WinLIMS allows a controlled environment for the development of new formulations, with all the iterative steps being recorded. This reduces the time of development of new products and promotes the optimization of existing products.
Complaints and Corrective Actions
This functionality allows for the recording of any complaints received concerning products. The system will record who submitted the complaint, the severity, classification, description, associated batch or lot number, status and date. Once the complaint is registered, the user can interrogate the system by a single mouse click to access all complaints for that product, for the specific lot or batch, and/or from that submitter. This capability allows for quick review of the complaint prior to assessing validity: if valid, then the complaint can be assigned to an individual for follow up and action. Results for the batch in question can be accessed directly from the complaints screen, and if required testing of the received product or retest of retained batch sample can be scheduled. All corrective actions made during the investigation of the complaint are recorded, complete with date, action taken, result, etc. Once a resolution to the complaint has been achieved, this will also be recorded and a final status applied to the complaint. The benefit of the integrated complaints functionality is that the original batch test data, and any further testing carried out as a resolution to the complaint, is available without the need to change applications.
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