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.
WinGPC UniChrom is a standard software package used in chromatography labs (commercial of the shelf product, closed system) and therefore meets specific requirements mentioned in 21CFR part 11:
* requirement 1: data security
* requirement 2: accuracy
* requirement 3: user authorization
* requirement 4: complete traceability
The very basic features data security, accuracy, and regulated software development and -documentation are completely fulfilled for WinGPC Unity.
Other 21CFR11 requirements for electronic records (traceability of meta data, audit trails, user authentication and electronic signature) are fulfilled for WinGPC Unity with Compliance Pack. The Compliance Pack module fits seamlessly into WinGPC, can be added easily, and supports all systems and software modules.
Additional Compliance Validation Features
Many WinGPC options and features help to release the burden on lab managers being responsible for validation:
- WinGPC Unity Install verification
- WinGPC Unity Software Validation and System Verification (see PSS AUTOVAL above)
- WinGPC support of PSS EaysValid for the validation of GPC/SEC systems independent on manufacturer
WinGPC users can easily validate their system using WinGPC functions and features.
For users who do not want to perform the validation themselves, PSS offers WinGPC validation and validation of the PSS SECcurity GPC System as a service.
The validation of analytical systems 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).