FDA Audit dOCUMENTATION.
A recently released FDA Warning Letter portrays a tighter interpretation of 21 CFR part 820.50, in so much as they expect to be able to review documented record for items a) to d) below. It must also be understood that other branches of the FDA (Drugs & Bio) have ascertained that when 21 CFR 211 lacks detail; they will audit to detail in 21 CFR 820 (if any).
Although the wording used in a) & b) would definitely identify them as applicable to medical devices parts; c) & d) are not. Also the fact that they mention in b) & c); that these requirements are applicable to - contractors and services rendered. This for many companies will be very disconcerting.
Extract from warning letter:
a) Your firm has not documented the evaluation and approval of suppliers of components used in the manufacture or assembly of the xxxxx xxx xxxx measurement device.
b) Your firm does not have a documented agreement with any component suppliers or contractors to notify it of changes made in the components supplied or services rendered.
c) Your firm has not established the requirements that must be met by suppliers and contractors.
d) Your firm does not maintain an approved suppliers list.
Precise extraction from WL CMS Case #175552
Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
combination protocol has been produced in response to several hundred
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. It is an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to
facilitate ease of final editing by the end user. It has become a very
Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00
Software Validation SOP (Issue-2) -- $22.00
Software Validation Master Plan (issue-2) -- $115.00
Software Validation Risk Assessment (Issue 2) -- $125.00
Software User Requirements Specification. (Issue 2) -- $115.00
Software Validation Plan (Issue 2) -- $89.00
Software Design Qualification. (Issue 2) -- $89.00
Software Installation Qualification. (Issue 2) -- $89.00
Software Operational Qualification. (Issue 2) -- $89.00
Software Performance Qualification. (Issue 2) -- $89.00
Software Validation Package (Issue 1) -- $699.00
A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)
Do use a Gap Analysis and avoid these embarrassing events. Gap Analysis Tool (Issue 2.) -- $115.00
Validation Risk Assessment (Issue10.) -- $125.00
This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.