Documentation and Compliance

With the entrance of the information technology, the US Food and Drug Administration (FDA) has increased the demands for documentation. Especially, GxP areas in pharmaceutical industries, but also suppliers of the chemical industries are concerned. Information that formerly simply was filed in paper format is today a matter of strong obligations regarding traceability and secure data storage. This results in two basic requirements  

A high degree of traceability has already been reached by optimized control options for chromatography instruments. 

Besides the chromatogram, the instrument method is stored as well. In addition, the single work steps of the user, from the start of a measurement to the final result, must be stored in a traceable manner. In this aspect, database-supported CDS offer high benefits. Relations between single information can simply be depicted in a database, whereas file-based systems are charged with a redundant amount of information. 

However, regarding the demand of archiving data, file-based systems offer one of the few advantages As all data are kept in simple folder structures, those can 

---

Bulk product assessment this should cover all relevant factors, including production conditions, the results of in-process testing, a review of manufacturing documentation and compliance with the product specification file and the order. 

Implementation of effective pre-experiment review programs must be initiated and backed by the highest level of leadership in an organization. Primary responsibility for day-to-day implementation of such programs should rest with individuals who supervise particular laboratory activities. While the experiments may be prepared and conducted by the laboratory workers, it remains the responsibility of the laboratory supervisor to determine what level of experiment planning is appropriate and to be accountable for necessary training, documentation, and compliance with regulations. 

A modular scanner system for NDE has been developed. It consists of a selection of individual electronics and motor module components, supported by scanner configuration and control software. The modules are used as standard building blocks for construction of job specific, dedicated scanners as well and general purpose scanners. The use of modular scanner components significantly reduce the work, time and cost not only for the design and manufacture but also for establishing documentation and ensure compliance with the relevant EU-directive requirements. 

The following documents and records should be reviewed as appropriate, and observations noted. Some of these documents may not be available as they can contain proprietary information for other clients. Place emphasis on determining whether the toller has established procedures and a management system adequate to ensure ongoing compliance. 

Ensure compliance with requirements specified in relevant approved documents and schedules to the regulations. 

Kanholm, Jack. ISO 14001 Requirements 61 Requirements Checklists and Compliance Guide. Pasadena, Calif. AQA Press, 1998. - Interprets and explains the ISO 14001 standard as 61 distinct requirements and discusses, with respect to each of these requirements, how to implement, required documentation, and what auditors will look for as evidence of compliance. 

The standard requires the supplier to comply/ with all customer requirements for designation, documentation, and control of special characteristics and to supply documentation showing compliance with these requirements. 

FDA. Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997). 

The packaging material should normally be selected so as to allow the optimal sterilization process to be applied to the product as a whole. Lfowever, factors other than the method of sterilization have to be taken into account in selecting a container material, such as the route of administration and patient convenience and compliance. Where the choice of container-closure precludes the use of terminal processing in the final container, the application should include appropriate documentation to explain and scientifically justify such a choice. The guidelines indicate that in such cases it is still the manufacturer s duty to continue the search for alternative containers that would allow terminal processes while providing the necessary product characteristics. 

Patterns of abortive medication use can be documented to establish the need for prophylactic therapy. Prophylactic therapies should also be monitored closely for adverse reactions, abortive therapy needs, adequate dosing, and compliance. 

Pressure design of unlisted components and other piping elements to which the rules in para. IP-3.1 do not apply shall be based on calculations consistent with the design criteria of this Code. These calculations shall be substantiated by one or more of the means stated in (a) through (d) below, considering applicable dynamic, thermal, and cyclic effects in paras. IP-2.1.7 through IP-2.1.8, as well as thermal shock. Calculations and documentation showing compliance with (a), (b), (c), or (d), and (e) shall be available for the owner s approval ... 

Category 3—Standard Software Packages These are commercial, off-the-shelf software packages. The package is not conhgured, and process parameters may be input into the application. The name and version should be documented and verihed during IQ. Compliance to URS should be tested during QQ. Supplier documentation should be assessed and used. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

The study is performed according to a plan approved (by dated signature) by the study director and verified for CLP compliance by the QA unit. Some countries also require formal approval by the test facility management and the sponsor. The plan should usually contain identification of the study, the test item and reference item, information concerning the sponsor and the test facility, dates, test methods, documents and materials to be retained, and other issues that have been identified. 

Validation is the final step to guarantee that a LC-MS system performs as expected. Validation includes instrument calibration, tuning, testing, and checking of the documentation for completeness, correctness, and compliance with SOPs. Validation consists of four separate steps ... 

---