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To receive free validation downloads please complete details as required below. Your copy of your selected document is only seconds away. Documents that are offered for free download have a faint watermark of the Validation Online email address. These documents are for your own use and are not editable but are able to be copied. We intend to extend this document list over the next few months.




EU Computer Annex 11 Latest.

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PHARMACEUTICAL GLOSSARY.

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F111 Matrix for Part 11 Justifications.

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SOP FOR EQUIPMENT VALIDATION.

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FREE VENDOR AUDIT CHECK LIST.

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AUTOCLAVE TEMPERATURE MAPPING METHOD STATEMENT.

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CORRECTIVE ACTIONS REPORT.

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Free Validation Downloads (November-Newsletter)

We have encountered many companies that claimed that they operated a ‘no blame culture’, where employee regulatory compliance is questioned.  They in their infinite wisdom seemed to think this was perfectly acceptable.  The harsh facts are that the regulators expect everyone to be accountable for their respective actions and are quite prepared (after due legal process) to demand custodial sentences for serious infringements.  We have on several occasions had to edit client policy documents (in the light of regulatory comments) to reflect that certain regulatory infringements by staff, would no longer be considered as minor mistakes and would carry more severe penalties; such as employment termination and accountability assessment.  Below is an extract from an FDA document regarding CAPA compliance; it is informative to note how often they refer to the individual’s responsibility and accountability.        

Content of the Corrective Action Operating Plan (CAPA) - The corrective action operating plan should include:

  1. An analysis of the audit findings, including an analysis of-all identified instances of wrongful acts associated with applications submitted to FDA, identification all individuals who were or may have been associated with or involved in the wrongful acts, and identification of defective practices, procedures, products, and applications;
  2. The disposition of any recommendations made by the consultant;
  3. A description of the actions taken and to be taken to achieve correction of fraud and other wrongful acts or deficiencies identified by FDA and discovered by the internal review;
  4. A timetable for implementation of the corrective actions;
  5. Identification of the persons responsible for taking and assuring the satisfactory completion of each of the corrective actions according to timeframes;
  6. A comprehensive ethics program that describes standards for employees and procedures for educating employees about the program and for enforcing the program; and
  7. The procedures for monitoring the effectiveness of the operating plan and to assure that the applicant can be expected to manufacture products in compliance with current good manufacturing practices and application requirements.
  8. In addition, the corrective action operating plan should establish a mechanism for assuring that supervisory, technical, and scientific employees are made aware of the requirements of the Federal Food, Drug, and Cosmetic Act in their area of responsibility, as well as the requirements under 18 USC 1001.

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Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.