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 to ensure good practice. For GPC/SEC the following international GPC/SEC rules and guidelines are available:
- ISO 13885
- ISO 16014
- ASTM D 5296-05
- DIN 55672
WinGPC UniChrom assures the quality, integrity and reliability of the complete data system by meeting all validation and compliance requirements. WinGPC fully complies with national and international GPC/SEC/GFC standards such as ISO/EN 13885, DIN55672, ASTM D 5296-05, JIS, BR and others.
To prove the correctness of WinGPC data treatment and calculation routines PSS has developed AUTOVAL.
During this process raw data of a known theoretical molecular weight distribution were automatically processed with WinGPC and the results for
- conventional GPC/SEC
- conventional GPC/SEC with noisy signals
- and GPC/SEC-LS
were compared with the theoretical results. WinGPC AUTOVAL is an integral part of every WinGPC UniChrom installation, allowing WinGPC users to proof with one mouse click that the WinGPC UniChrom installation on a specific data station processes data correctly.
WinGPC is designed in accordance with FDA 21CFR11 requirements to provide a full feature set to help companies using macromolecular chromatography comply with these regulations. 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
Requirements 1 and 2, data safety, accuracy as well as regulated software development and -documentation are achieved with all WinGPC UniChrom installations.
The optional WinGPC Compliance Pack adds functionality to achieve user authorization (requirement 3) and complete traceability (requierement 4) by offering compliance support for US Code of Federal Regulations, Part 11, Title 21 (21 CFR 11), Eudralex Chapter 4, Annex 11, GAMP 5 with
- Secure login
- Administration and User Levels
- Electronic signatures
- Additional Audit trails
- Procedural software controls to support users to stay compliant
Documentation can be stored in the comprehensive PSS System and Software Validation Binder for product life cycle management.
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
Good documentation practices (GDocP) are required to achieve accuracy, completeness, consistency and reliability of records and data throughout their life cycle requires. ALCOA and ALCOA plus are acronyms used in a regulated environment describing the expectations towards documentation of paper and electronic records.
- Attributable: Who acquired the data/performed an action?
- Legible: Are the data entries readable and understandable?
- Contemporaneous: Is it documented at the time of the activity?
- Original: Is it a first recording of data or a true copy?
- Accurate: Does it reflect what took place?
- Complete: Do the records show the complete picture?
- Consistent: Is it free of contradictions and inherently coherent?
- Enduring: Is it unchanged throughout the retention period?
- Available: Are data accessible to be viewed over the record lifetime?