Compliance Certainty with WinGPC UniChrom
Since the mid 70-ties of the last century public agencies have worked on GxP, validation, and qualification to protect citizens and environment from hazardous materials and to ensure product safety. They created guidelines and rules that should be followed.
For GPC/SEC the following international GPC/SEC rules and guidelines are available:
- ISO 13885
- ISO 16014
- ASTM D 5296-05
- DIN 55672
Every WinGPC version (stand-alone or Client/Server, compact, OEM) allows GPC/SEC analysis fully compliant to these standards.
In addition to this, a new software validation procedure, PSS AUTOVAL, has been established for WinGPC UniChrom. Raw data of a known theoretical molecular weight distribution were processed with WinGPC UniChrom. The results for
- conventional GPC/SEC
- conventional GPC/SEC with noisy signals
- and GPC/SEC-LS
were then compared with the theoretical results. The validation is passed when the results are identical or only small deviations (due to numerical errors) below 0.05% occur.
PSS AUTOVAL has been used to prove the correctness of WinGPC UniChrom data treatment and calculation routines. It has also been incorperated into WinGPC UniChrom, so that WinGPC users can easily proof with one mouse click that WinGPC UniChrom installed on their data station works correctly.
A detailed description of the software validation procedure is included in the WinGPC user documentation: "PSS WinGPC Software Validation" Brochure. A short discussion can be found here (GPC Symposium San Diego, pdf).
FDA 21CFR part 11 Compliance
The FDA (US Food and Drug Administration) has published 21 Code of Federal Regulations part 11 (21 CFR Part 11) for the treatment of electronic records and signatures. Laboratories have to comply with part 11 if:
- computers are used to create, modify, maintain, archive, retrieve, or transmit data
- when at any time electronic records hit a durable storage device
- when the laboratory intends to create records that are intended to be submitted to or required by the FDA.
More information: FDA 21CFR11
WinGPC UniChrom is a standard software package used in chromatography labs (commercial of the shelf product, closed system) and has therefore to meet specific requirements, also mentioned in 21CFR part 11:
- requirement 1: data safety
- requirement 2: accuracy
- requirement 3: user authorization
- requirement 4: complete traceability
The very basic features data safety, accuracy, and regulated software development and documentation are completely fulfilled for WinGPC UniChrom.
Additional 21CFR11 requirements for electronic records (e.g. traceability of meta data, audit trails, user authentification and electronic signature) are fullfilled for WinGPC UniChrom with Compliance Pack. The Compliance Pack module fits seamlessly into WinGPC, can be added easily, and supports all systems and software modules.
Additional Services and Products for Compliance
The validation of analytical systems is not an easy task. Validation is an ongoing complex process that evaluates the entire, sample specific process, products, and analytical methods. Validation consists of several qualification phases that verify pre-defined performance specifications (design (DQ), installation (IQ), operation (OQ), and performance (PQ).
Many WinGPC options and features help to release the burden on lab managers being responsible for validation:
- WinGPC Unity Installverification
- WinGPC Unity Software Validation and System Verification (see PSS AUTOVAL above)
- WinGPC support of PSS EasyValid for the validation of GPC/SEC systems independent on manufacturer
Therefore WinGPC users can easily validate their system using WinGPC functions and features.
For users who do not want to perform the validation theirselfs, PSS offers WinGPC validation and validation of the PSS SECcurity GPC System and the EcoSEC GPC System as a service.
Part number: 899-0021
The PSS contract analysis lab and the PSS column technology department offer their support for the validation of customer applications as well.
Please contact us for further information.