Home
Services
Markets
Recent Projects
Experience
Applications
FAQ
Contributors
Contact Us
E-literature
Search and Links
Ask us a question about equipment validation and we will endeavor to find you the answer or at least point you in the right direction for one.

We appreciate any comments and tips on how to make The FAQ page a better information source. Please contact us by e-mail at Questions@SMBvalidation.com if you find any faults, inaccurate, or otherwise unacceptable information.

The content in The FAQ page can be used with NO WARRANTY or LIABILITY. Important information should always be double checked with alternative sources. All applicable national and local regulations and practices concerning this aspects must be strictly followed and adhered to.
1 Why Validate?
2 What is Validation?
3

Who is responsible for Validation?

4

What is an IQ?

5

What does an IQ contain?

6

What is an OQ?

7

What does an OQ contain?

8

What is a PQ?

9

Why produce a PQ?

10

What does a PQ contain?

11

What is a SOP?

12

Why produce a SOP?

13

What is an URS?

14

Why produce a URS?

15

What does a URS contain?

16 What is FRS?
17 Why produce an FRS?
18 What does an FRS contain?
19 What is a DDS?
20 Why produce a DDS?
21 What does a DDS contain?
22

What is an FAT?

23

Why produce a FAT?

24

What does a FAT contain?

25

What do we need to satisfy 21 CFR Part 11?

26

What is GAMP5?

27

As an equipment supplier what Quality Planning do we need?

28

What industries does SMB serve?

29

Why should I choose SMB as our validation provider?

30 How can we be assured that information provided as part of project is maintained as propriety and confidential?
31 What is an SAT?
32 Why is SAT required?
33 What does a SAT contain?
34 Can a vendor guarantee compliant software for Part 11?
35 Does Part 11 apply to electronic systems that can print records but do not have a durable storage media (i.e. flash memory or memory buffer, etc.)?
36

What is the definition of hybrid system? Could you give an example of one?

37

If using a 'hybrid system' approach to e-signatures, how do you link the handwritten signature to the e-record?

38

What are some examples of audio data that may be captured in the Pharmaceutical Industry? Specific Examples?

39

I keep electronic records but have signatures on paper (hybrid systems). Is there a deadline for converting to electronic signatures?

40

When does an audit trail begin?

41

Should execution of a signature be audit trailed?

42

Are e-mails controlled documents?

43

Can a single restricted login suffice as an electronic signature?

44

When are e-signatures required?

45

Should a company individually certify that every associate's electronic signature is legally binding?

46

FDA has issued a new guideline on data and time. It is not mandatory that it is local?

47

Does outsourcing of a computer make a system an open system? Additionally would the external access of an external vendor for maintenance work (e.g. using a modem) to a computer system make that an open system?

48

What do you mean by linking e-records to e-signatures?

49

Can you share a sample FDA Warning Letter, or is that proprietary information?

50

What is 'grand fathering'?

51

What is GxP?

52

What is a 'Predicate Rule'?

53

Are HIPPA regulations considered a predicate rule with regard to medical records maintained electronically?

54

How can you make sure that e-records are still readable throughout the retention period (with focus on the formats)? Currently mostly proprietary formats are in use (e.g. in the lab area) and the possibility to read these formats in a few years is difficult (especially if the vendor is changed). Printing or converting into PDF or similar is only a partly solution. 'What would/could be a long-term solution here?

55

What is 'metadata'?

56

If you use Electronic Signatures, do you have to comply with Electronic Record Requirements?

57

Do you have a format or example for the certification for e-signatures that a company can send to the FDA?

58

Which kind of media (CD Roms, WORMs, etc.) can be considered "21CFRPart11 compliant" from point of view of good retention period?

59

How do you recommend handling CROs and vendors in a timely basis?

60

What must a vendor do to claim that their hardware and software are 'compliant' with 21 CFR Part 11?

61

Does Part 11 apply to instruments themselves that are not connected to computers but that have microprocessors within?

62

Are electronic signatures always required on the creation of electronic records?

63

Is a 'Gap Analysis' a necessary step to become 21 CFR Part11 compliant?

64

If a GLP computer is in a lab with physical access control to the doors to the lab, but the application software on that lab computer has no logical access control, does this system comply with Part 11?

65

What are the expected means for reporting attempts at forging electronic signatures?

66

What is an appropriate audit trail for an Excel Spreadsheet? Some indicate you should track every single cell change and others say it should be tracked the same way a document management system would do it (track final versions only, intermediate drafts don't count only after all changes have been made and approved)?

67

Please further elaborate/define "Hashing"

68

In Part 11.300, controls for identification codes/passwords usage is listed under Subpart C -- Electronic Signatures. Are these requirements only applicable if your system is utilizing e-signatures? It seems that these should be applicable to any system with e-records.

69

Given the fact that most of the systems needing to be compliant are usually found not to be compliant and are usually replaced, does it make sense to do a gap analysis or go directly to remediation?

70

Is an audit of a vendor enough to ensure that the technical controls (in their product) are all present and compliant?

71

Could you define and provide examples of systems that are critical to "data integrity"?

72

Technical solutions may take sometime to implement, what is FDA position on timelines?

73

What type of 'reporting' capability on audit trail data should be supported?

74

For clinical data management systems, where does the audit trail begin.... after first entry or after the data has been verified and uploaded to the data management system?

75

How does the digital signature verify that the document hasn't been altered after signing?

76

For an HPLC system, are the parameters entered for a chromatographic run considered an electronic record?

77 Government regulations and guidelines often use the words "validate" and "verify," but what's the difference?
78 What is a Chiller Refrigeration Ton?
79 How do I calculate a Heat Load/Water Flow?
80 What are the clean room class limits according ISO Standard 14644-1?
81 What are particle sizes presented in millimeters?
82 What are the clean room class limits according Federal Standard 209?
83 What does the FDA look for when inspecting a Purified Water System?
84 What is ANSI/ASQ Z1.4-2003?
85 What is MIL-STD-105?
86 Is MIL-STD-105E still used?
87 What is the difference between MIL-STD-105E and ANSI/ASQ Z1.4-2003?
88 What is the difference between ANSI/ASQC Z1.4 1993 and ANSI/ASQ Z1.4-2003?
89 What is an Acceptance Number?
90 What is an Acceptance Quality Level (MIL-STD-105E, ISO 2859-1 (1999))?
91 What is an Acceptance Quality Limit (ANSI/ASQ Z1.4-2003)?
92 What are Defects and Defectives?
93 What is a Double Sampling Plan?
94 What does “Drawing of Samples” mean?
95 What is “Expression of Nonconformance”?
96 What does “Defects per Hundred Units” mean?
97 What is “Inspection”?
98 What is “Inspection by Attribute”?
99 What are the Inspection Levels?
100 What does “Lot or Batch” mean?
101 What does the term “Nonconformance” mean?
102 What is “Normal Inspection”?
103 What does “Percent Defective” mean?
104 What is a “Reduced Inspection”?
105 What is the “Rejection Number”?
106 What is “Representative Sampling”?
107 What are “Resubmitted Lots or Batches”?
108 What is a “Sample”?
109 What are “Sampling Plans”?
110 What is a “Single Sample Plan”?
111 What does “Severity of Inspection” mean?
112 What does “Unit of Production” mean?
113 What is “Tightened Inspection”?
114 What is “Discontinuation of Inspection Rule”?
115 Why should I consider SMB for my next qualification project?
116 What is FMEA?
117 What types of FMEA are there?
118 What is DOI?
119 What is a PPM?
120 Can SMB validate an Oyster Manesty XPress 500?
Download Vcard
Download Reader
View Publications
Need a Quote?
Download Reader
Download Winzip
News, Events, Validation Master Plans, IQ, OQ, PQ, 21 CFR Part 11 gap analysis, Summary Reports, CSV, GXP, GMP, cGMP, GAMP5, SOP’s, URS, FRS, URS and DDS Generation for all packaging and processing equipment
HOME | SERVICES | MARKETS | PROJECTS | EXPERIENCE | FAQ's
APPLICATIONS | CONTACT US | CONFIDENTIALITY STATEMENT | SITE MAP
© SMB Validation & Compliance Services Group Inc, SMB Group, SMBValidation.
- Site development by Mars Media Design -