Signature policy

The legal provisions in connection with signatures are very country-specific and complex. Therefore they cannot be discussed within the framework of this book. Moreover, most of the companies have their own continuative and detailed signature policy to which employees have to adhere. 

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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 Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997).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 anticipated prorated payment, if any, to the participant for participating in the trial A statement of dosage/frequency and the probability for random assignment to each treatment An explanation of whom to contact for answers to pertinent questions about the research and research participants rights and whom to contact in the event of a research-related injury to the participant A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled A place for signatures by the participant, physician, person obtaining consent, and witness (less signatures may be required) it depends on the policies and procedures of the particular IRB... 

Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures... 

In the hospital setting, drugs are prescribed on a particular page of the patient s hospital chart called the physician s order sheet (POS) or chart order. The contents of that prescription are specified in the medical staff rules by the hospital s Pharmacy and Therapeutics Committee. The patient s name is typed or written on the form therefore, the orders consist of the name and strength of the medication, the dose, the route and frequency of administration, the date, other pertinent information, and the signature of the prescriber. If the duration of therapy or the number of doses is not specified (which is often the case), the medication is continued until the prescriber discontinues the order or until it is terminated as a matter of policy routine, eg, a stop-order policy. 

An efficient document management and control system is essential for minimizing the costs of a process validation effort. Detailed discussion of document management is beyond the scope of this chapter however, one suggestion is offered that has proven particularly successful. Efficiency of the document review and approval process can be greatly enhanced by a policy that defines the purpose of each signature required (e.g., technical correctness, regulatory compliance, compliance with other corporate documents, and authority to pro-... 

FDA, CPG 7153.17, Enforcement Policy 21 CFR Part 11 Electronic Records Electronic Signatures, May 1999. 

An appropriate signature sign-off, as defined in the validation plan, must be obtained prior to officially utilizing the system in its operating environment. Once the system is considered validated, all applicable policies and procedures governing the operation of the validated computer system become effective. A formal written notification should be issued to the system users and to QA to officially inform them that the system is validated and can be used in operational environment. 

All regulatory documents presumably are subject to a tripartite review process. The submission is reviewed by the corporate Regulatory group, which proofs, considers issues of conformity to internal policy and to FDA guidance and checks the factual statements. A Quality Assurance review then rechecks all the previous items and independently confirms all facts and statements. Finally, a corporate review (at or near the top of the organization) precedes the final signatures and confirms conclusions and plans. 

Compliance Policy Guide (1999), Enforcement Policy, 7153.17 21 CFR Part 11 Electronic Records, Electronic Signatures, Food and Drug Administration, Rockville, MD. 

Compliance with Client Policies (e.g., GxP, qualification, electronic records and signatures)... 

Is there a written policy that makes it clear that individuals are fully accountable and responsible for actions initiated under their electronic signatures in the same way as for their hand-written signatures and has this policy been communicated 11.10 ... 

I32a.I5) Input/Output Checking (CPG 7I32a.07) Identification of Persons on Batch Production and Control Records (CPG 7I32a.08) Enforcement Policy 21 CFR Part II Electronic Records Electronic Signatures (CPG 7153.17). 

Review the final clinical report, and sign and date the signature page after review Allow an independent audit and/or inspection of all study documents and facilities Agree to the publication policy Agree to the sponsor s/CRO s ownership of the data... 

Electronic Signatures — Compliance Policy Guide Guidance for FDA Personnel, FDA, 1999. http //www.fda.gov/ora/compliance ref/partll/FRs/updates/cpg-esig-enf-noa.htm. 

Prior to publication of the 1987 GLP revisions, many laboratories prepared combined reports, and the author knows of no instance in which the FDA rejected a study for failure to provide signed and dated reports from each of the scientists or other professionals involved in the study. For such laboratories, it is probably advisable to reconsider prior policy on report preparation. The intent of the regulation (to provide accountability) can be met with the format of a combined report, but with an indication on the signature page of the portion of the report prepared by each signatory. 

The security of documents from an intellectual property (IP) standpoint is at the very least questionable. This applies particularly to patent relevant fields. According to U.S. patent policy, the date of invention is relevant for deciding who is the patent owner. This is different, for instance, from the European patent policy, where the date of filing the patent with the European Patent Office constitutes the patent ownership. However, creating documents on a local file system does usually not ensure the appropriate time stamp and does not allow applying electronic signatures, both of which are necessary for patent relevant documentation. 

The number of signatures for records or documents needs to be configurable according to institntional policies. It must be possible to switch off the signature feature for individual records. 

Signature Workflow refers to the process of release, signature request, and signature of electronic data in a sequential manner according to internal policies. 

It is the official policy of the I.O.N.S. Corporation for the memo writer to sign the memo at the bottom following the last paragraph. First, the word Sincerely is typed, followed by the signature. Following the signature, the writer s full name shall be typed. 

In addition to seasonal signatures, we want to understand vertical fluxes and urban regional source sinks driven by human activity. We understand chemical transformations very well as illustrated by the Los Angeles basin. We know exactly what reactions are taking place, but the lack of specificity on the location and strength of sources and the way those couple into the chemical transformation serves to prevent a link between science and public policy on that question. 

Experimental design and methods Schedule of assessments Subjection selection criteria Screening procedures for entry Study parameters Trial medication Premature withdrawal Subject replacement policy Criteria for excluding data Statistical analysis plans Signatures... 

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