FDA inspection

 Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection.

 

(f) This part does not apply to records required to be established or maintained by §§ 1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(g) This part does not apply to electronic signatures obtained under § 101.11(d) of this chapter.

 

(h) This part does not apply to electronic signatures obtained under § 101.8(d) of this chapter.

 

(i) This part does not apply to records required to be established or maintained by part 117 of this chapter. Records that satisfy the requirements of part 117 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(j) This part does not apply to records required to be established or maintained by part 507 of this chapter. Records that satisfy the requirements of part 507 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(k) This part does not apply to records required to be established or maintained by part 112 of this chapter. Records that satisfy the requirements of part 112 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(l) This part does not apply to records required to be established or maintained by subpart L of part 1 of this chapter. Records that satisfy the requirements of subpart L of  fda 21 cfr part 11 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(m) This part does not apply to records required to be established or maintained by subpart M of part 1 of this chapter. Records that satisfy the requirements of subpart M of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(n) This part does not apply to records required to be established or maintained by subpart O of part 1 of this chapter. Records that satisfy the requirements of subpart O of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(o) This part does not apply to records required to be established or maintained by part 121 of this chapter. Records that satisfy the requirements of part 121 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004; 79 FR 71253, 71291, Dec. 1, 2014; 80 FR 71253, June 19, 2015; 80 FR 56144, 56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, Nov. 27, 2015; 81 FR 20170, Apr. 6, 2016; 81 FR 34218, May 27, 2016]

 

§ 11.2 Implementation.

 

(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.

 

(b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:

 

(1) The requirements of this part are met; and

 

(2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.

 

§ 11.3 Definitions.

 

(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.

performance management

In companies with fewer than 500 employees, for example, these decisions can often be made intuitively. In addition, the positive effect on the performance of meritocracy through variable remuneration based on performance (pay for performance) is scientifically quite controversial, with studies with inconclusive and often counterproductive results.

 

Read more: about motivation, bonuses and Daniel Pink

 

Strategy and performance management

Another important effect of performance management processes   is the execution of the company's strategy.

 

In many organizations, the results produced by employees are evaluated using goals that are broken down from strategic objectives — mission, vision, short and medium-term planning — and therefore tend to contribute to the company's strategy being executed.

 

Even if there is no breakdown of goals, objective numbers can be measured, such as:

 

quality — for example the percentage of defects on a production line;

productivity — the number of invoices processed;

cost — the adherence of a company board to the annual budget.

In all cases, whether or not there are goals, results that are aligned with the organization's strategy can be measured, thus ensuring the achievement of its strategy.

 

Culture and performance management

Another slightly more subjective aspect of a performancemanagement program is to  ensure that the company's employees are acting on a daily basis in accordance with the culture and precepts defined as important by the organization.

 

This can happen both in measuring the behavior of employees and in directing – developing – their behavior in alignment with the company's cultural behavior.

 

Legal Aspects of Performance Management

Finally, performance management can serve an important legal role in companies, as it serves as evidence of work performance for any labor claims that a company may suffer from its employees. For this, it is important that the processes are properly documented in reliable systems, which can be consulted for a long period, and that they maintain a “record” of the employee.

 

It is noteworthy that the quality of a system for legal purposes can often conflict with the quality of the system for employee development purposes. In these cases, it is up to the company to consult legal experts and weigh both purposes in the design of its system.

 

What are the two dimensions of performance?

Most experts divide professional performance into two broad dimensions:

 

results (outcomes);

behaviors (behaviors);

An intuitive way to understand the difference between results and behaviors is to think that results are “what” the employee produces, and behaviors are “how” the employee produces those results.

 

Both dimensions of performance are important as they will serve as the backbone for the performance management cycle, which we will discuss later.

 

What is the performance management cycle like?

The performance management cycle is the main process of a performance management program.

 

performance expectations

The beginning of any performance management cycle is the definition of performance expectations between the employee, their manager and the company.

 

Performance expectations are represented and communicated in different ways among these three participants. Let's go to some of them:

 

job description

 

The job description is the most fundamental document for defining expectations between an employee and the company. When well written, it must outline, always in relation to the position/function filled by the employee:

 

The “mission”, that is, for which the position/function exists;

The main responsibilities associated with it;

The main indicators that measure success in the role;

The skills, knowledge and skills required.

Many companies ignore the job description because they turn them into dead, boring and generic documents, which end up saying nothing to the employee about what is expected of him. But the job description when properly used can be an extremely clear and objective way to define expectations.

 

behaviors

 

Another way to define a company's expectations of an employee is to define and communicate what behaviors are expected (the “how” we mentioned above).

 

Behaviors can be directly derived from job descriptions (which in turn come from the analysis of the work to be done – job analysis), they can be common to all employees (in the case of critical skills derived from the company's strategy) or even derived from values ​​of the company's culture.

 

In some companies, behaviors are common to all employees, and in others they can be specific to each position, seniority level and/or functional area (a mix of both types can also be used). Therefore, the matrix of behaviors for a given function can be derived from the work to be performed, the company's critical competences and its values, and even specific to the position, functional area or degree of seniority of the function.

 

If the employee knows what behaviors are expected of him, he can direct his behavior during the cycle, to work more in line with what is expected of him.

 

Read more: Your company does not know how to assess competences.

 

Activities, indicators, goals and projects: what are these points?

Another important aspect of an employee's expectations at each beginning of the cycle is the definition of the results to be achieved (the “what” we mentioned above).

 

The most traditional and basic way to define what is expected of an employee is by defining the activities that will be performed by him. Activities are usually derived from a study of the company's processes, which are broken down into steps and activities.

 

Activities

These activities are, in turn, assigned to different roles and employees. The main activities of a job/role are usually explained in its job description. An example of a task is “closing product sales contracts with current and new customers”, which can be defined as important for the employee, including the company, the company and the manager. Thus, at each beginning of the cycle, activities that the employee must perform are defined.

 

Indicators

One step ahead of activities are indicators, which are ways to measure the efficiency and/or effectiveness of activities performed by an employee. In this case, satisfactory levels for these indicators can be defined. An indicator linked to the example above, for example, is the “number of sales contracts for products closed per month”. Employee, company and manager can define at each beginning of the cycle, for example, that the employee must make as many “contracts” as possible.

 

goals

Ahead are the goals. Goals generally define objective levels that must be achieved by the employee in the indicators that measure their activities.

 

Here, the company, employee and manager define a level that generally involves the increase or reduction of an indicator (improvement goals) or its maintenance within acceptable limits (maintenance goals).

 

Examples: in the case above, it can be defined that the employee must close at least 30 product sales contracts in the cycle (starting from a performance of 27 in the previous cycle, that is, an improvement goal), and that the contracts are necessarily closed with payment terms between 45 and 60 days (a maintenance goal).