Sunday, September 05, 2010
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General Benefits
- PLA is a commercial off-the shelf application for assay analysis. It support parallel-line analysis according to Finney as well as full curve parallelism methods making use of four parameter and five parameter fits (4PF, 5PF).
- PLA is the only 21 CFR part 11 compliant application that allows parallel-line analysis according to the monographs of the Pharmacopoeias. (Note: The majority of monographs does not tell anything on full curve parallelism, but they do tell about parallel-line analysis using straight lines.)
- With the use of PLA your analytical methods remain independant of any vendor of laboratory equipment.
Easy To Use / Easy To (Self-) Train
- PLA has a modern user interface.
- PLA has an optimized approach for efficient assay definitions with ad-hoc templating etc.
- PLA can be easily self-trained. Tutorial videos are available in the online help and on this website.
Easy Validation
- PLA can easily be validated in your environment making use of the optional Validation Package. IQ and OQ have been partly automized. The optional Validation Package comes with over 1.500 pages of reference data.
- PLA does not allow any modifcations of its formulas / protocols and thus does not require to revalidate them.
Statistical Features
- Supports both Parallel-Line Assays (Straight Lines) and Parallel-Logistics Assays (Full-Curve Parallelism, 4PF, 5PF)
- Multiple Methods for Testing the Parallelism incl. Equivalence Testing
- Multiple Outlier Detection Methods: (Externally) Studentized Residuals, Dixon, Grubbs, s2)
- Configuration Optimization for Parallel-Line Assays
- Extended Dose/Dilution Handling
Integration
- Vendor-independent Import of Data from your Acquisition Software
- Extended Import Modules. Extended Import Modules are able to run complex analytical task and to create assay data from the results of these tasks (e.g. analyze flow cytometric data or process kinetic calculations)
- Export your data to any target system (LIMS, Documentation Systems)
- Report Templates for Output to Adobe PDF (tm), Microsoft Word (tm), Microsoft Excel (tm) and any other formats. Indivdual Templates can be created.
Fit for the Enterprise
- 21 CFR Part 11 compliance:
- User Account Management incl. password history, complexity, ageing, black lists, lock-out)
- Audit Trail
- Electronic Signatures: Assay data can be signed by any number of operators
- Digital Signatures assure the integrity of data, user accounts, system options.
- Security relevant data is kept together in one database to protect from any breach of security. PLA does not make use of user account files, that could me manipulated or transfered. The database itself builds a security zone.
- Using its internal PKI, PLA allows to securly transfer assay data including electronic signatures between organizations. Integrity of the data is assured by digital signatures.
- SOP support: Templates and access restrictions to parts of your assay definitions
- The integrity of report templates is checked every time a calculation is run.
- PLA does not allow the manipulation of any formulas.
(Background: Report/Protocols are quality relevant parts of the system, that should not be modified. If they are modified, this has to be clearly stated in the protocol and the whole protocol has to be revalidated. PLA prevents the user from this effort. Verified Individual Templates are available from the vendor only.)
