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					                              Genryme       Corporation
                              One Kendall      Square
                              CambrIdge,       MA 02139-1562, US A
                              T 617-252-7500
                              F 617-374-7470
Dockets Management Branch                                            1572    33 APR,-7 A931
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Subject:         Docket Nos. 03D-0060,99D-1458,OOD-1538, OOD. 1543,00D-1542 and OOD-1539
                 Draft Guidance for Industry on “Part 11, Electra nit Records, Electronic
                 Signatures - Scope and Application”

4 April, 2003

Dear Sir/Madam:

Thank you for the opportunity to comment on the Draft                            for Industry on “Part 11,
Electronic Records, Electronic Signatures - Scope and Applicatio                   published in the Federal
Register on February 25,2003. Below are Genzyme’   s                             r your consideration.

1. We request that FDA state unequivocally that Part 11 is still                 effect at the start of the draft
   guidance, as we have noticed many differing opinions throu                    out the industry and its

2. Please define the term “fewer records” in 5111A. It is our            that FDA means that
   process automation software
   records for the
   configuration management processes (paper and electronic)
   unclear as to whether the concept of “durable media” as a def
   created is still applicable. This
   osmometers, TOG meters, etc.)
   device that may reside on a durable media until overwritten,  re also exempt, with the
   exception of robust configuration managem,ent/metrology/S      P control programs already in

3. In 3111A, it would be helpful if the items listed in the parenth ses were directly related to the
   rule elements they reflect.

4. We request further definition of “enforcement discretion” me                         in 5111A, and some
   characterization of the enforcement process. Does FDA consi                                   to be part of the
   escalation process detailed in the dispute resolution proposal

5. In 3111B 1, please clarify whether the term “merely incidental” * eludes security and controls
   that enable us to prove that we have content integrity. We als request that FDA list classes of

           Wb               1-9
                                  Docket       Nos. 03D-OO60,99Dl458,OODl5
                                                                                 8,OOD-1543,OOD-1542    and OOD-1539
       www genzyme   corn                                                    T                             Page 1 of 3
     instruments   or types of technologies covered by “incidental.’ use.

6.   $111B 2, Bullet Point 2 suggests that hybrid environments w:.ll always be taken into account
     under the business practice considerations. We note that ofl.icial documentation via SOPS will
     not assure that e-records versus paper records (or vice versa) prevail. How will FDA
     distinguish whether records or the context in which records are used fall under performance
     of a regulated activity?

7. We are unclear as to what the Agency intends in 5111B 2, Bullet Point 3. It would seem that
   submission requirements are covered under predicate rule.

8. We note, in 3111B 2 Bullet Point 4, that electronic signatures are not equivalent to “initials and
   other general signings.” Electronic signatures are legally bir.ding equivalents of handwritten
   signatures. We believe that FDA should provide clear distir-ction between electronic
   signatures as opposed to electronic identity (that which is achieved by logging in to a
   computerized system).

9. The first paragraph in 5111C 1 suggests that audit trails do not necessarily require validation
   when a computer system is validated. Please confirm.

10. 5111C 1 paragraph 2 states ” . . . it may be important to         the systems to ensure the
    accuracy and reliability of part 11 records contained in              in the absence of a
    predicate rule requirement. Please explain the distinction b tween tools (applications that
    create predicate rule e-records) and systems (that                    rule records). For
    example, the use of Microsoft Word to create an                ith a resultant electronic record)
    versus SAP (an application that contains predicate rule elec                 for product
    traceability and release).

11. Paragraph 2, 5111C 2 seems to indicate all systems and inter ces require risk assessments as
    part of a central system validation effort, regardless of       rule influences. This seems
    inconsistent to us. Does FDA intend to be able to inspect su systems under routine agency
    visits? Please consider the following example. If a Human              management system
    passes information to a predicate rule training system,                          system
    required to apply audit trails and controls to meet Part ll?       an audit trail be applied at
    the interface level?

12. §I11 C 3 implies that a retired system or a static system does      ot have to be remediated. If a
    system was in existence prior to August 1997, (i.e., a legacy              and the applicable
    application has since been upgraded, will the Agency                              discretion” if the
    system is not Part 11 compliant? We believe that a
    technology/function-driven      rather than date driven, as the     te only constitutes part of the
    story for achieving compliance. Also in this                                            for intended

13. Please elucidate the Agency’ expectations during an inspec on in 5111C 4, specifically, what
    is considered “reasonable and useful access” to records d          an inspection? Will FDA
    expect to review paper or will inspectors need to perform ele tronic system review? The
    requirement for ability to search, sort or trend implies that th re may be a need to supply the

                                Docket   Nos. 03D-0060,99D-1458,00D-1
                                                                        38,OOD1543,OOD1542    and OOD-1539
                                                                                                 Page 2 of 3
    application. There are other types of files that could be         “technology neutral” such
    as CSV. We note that “technically feasible” can usually be ccomplished at great cost. We
    would like to ensure that our efforts produce usable data               for your inspectors.
    Please provide specific examples of what kinds of e-copies  e Agency expects to be
    processable versus static.

14. In III C 5, does FDA expect access to electronic copies of ret          records? In addition, does
    the Agency require electronic copies of audit trails, and are           audit trails expected to meet
    predicate rule retention requirements for their associated                Please clarify.

We believe that overall the draft guidance has been helpful in        terpretation of previous issues,
e.g., clarification in the use of “technology-neutral” copy form       , but has raised further questions
as noted earlier. In particular, we appreciate the enhanced                sk assessment when applying
Part 11 to different systems. We also believe that the ability to      ain electronic record information
in ways other than electronic form to meet long term retention          riods is useful. Genzyme
appreciates the opportunity to comment on the Draft Guidan                 Industry on “Part 11,
Electronic Records, Electronic Signatures - Scope and Appl                   Please contact me at (617)
374-7275 or Juliette Shih at (617) 761-8929 should you have              estions regarding this letter.

Rw        Yocher
Vice President
Regulatory Affairs

Juliette E. Shih
Clinical Operations Analyst
Biomedical and Regulatory Affairs Compliance

                               Docket   Nos. 03D-O060,99D1458,
                                                                 OOD- 538,OOPl543,OOD-1542   and OOD-1539
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