FlinkISO
CFR Complaince

On Cloud

Pay as you use. No long term commitments. Monthly billing. Dedicated instances for every organisation. Unlimited users, scalable.

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On Premise

Downlod copy of the application and install at your premise. Lite & Enterprise versions available. No per user / per seat cost. Perpetual License.

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Customise

With custom drag & drop HTML forms, organisation can customise the entire application as per their QMS requirments

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FlinkISO QMS Software
CFR Complaint Software


(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Every record goes via Approval Process
(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. NA
(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. Approval Process + Strong User Configurable Access Controls
(d) Limiting system access to authorized individuals. 2 Way Authentication Process ( Password + Digital Signatures)
(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. System Audit trails recording, Login session details, older Records + edited records details, maintaining complete change history for each record
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. NA
(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system, input or output device, alter a record, or perform the operation at hand. 2 Way Authentication Process ( Password + Digital Signatures)
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. 2 Way Authentication Process ( Password + Digital Signatures)
(i)Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks. NA
(j)The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. NA
(k) Use of appropriate controls over systems documentation including:  
(1)Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. Approval Process + Strong User Configurable Access Controls
(2)Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. CR module
Sec.11.50 Signature manifestations. Yes
(a)Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: Yes
(1) The printed name of the signer; Yes
(2) The date and time when the signature was executed; and Yes
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. Yes
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). Yes
Subpart C--Electronic Signatures Yes
(a)Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. Yes
(b)Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. NA
(c)Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. NA
(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. NA
(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. NA
(a)Electronic signatures that are not based upon biometrics shall:  
(1)Employ at least two distinct identification components such as an identification code and password. Use of 2 way authentication ( Username / Password & Digital Signature )
(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by and designed to be used only by the individual. Yes
(ii)When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. Yes
(2) Be used only by their genuine owners; and NA
(3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. NA
(b)Electronic signatures based upon bio-metrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. NA
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Core features

Every document is Version Controlled & Access Controlled and follows all the Document Management best practices.

With ONLYOFFICE™ Editors, you have complete control on your documents without loosing any formatting unlike online web-based HTML editors.

Simply upload the existing documents/ spreadsheets/ presentations to create the document.

With ONLYOFFICE™ Editors, you can preserve all your formulas and sheets in your spreadsheets.

You can easily create such spreadsheets, documents, formats etc and share with users within the system for scheduled data entry, eliminating efforts of printing & distributing these documents manually.

Users can open these shared documents from within the system, add their data and save them onto the system without any need to download/ upload.

To collect this data in SQL format instead of Document format, you are free to build HTML forms within the system by using our Drag-and-Drop feature.

No Coding Required

HTML forms created are automatically version controlled, ready with required validations as well as design/ layout you choose while creating these HTML forms.

Each of these forms are either linked with the document or with the process and by default inherit access restrictions based on document access.

Every form created, by default follows system's approval system. Users with limited roles, cannot publish any record in the system unless that record/ document is approved by HoDs or Administrators.

What Clients Say?
testimonials

The FlinkISO Online System certainly has revolutionized our business, it certainly allows us to work "smarter not harder".

The online tracker, database, reports, and graphs etc, have outperformed our initial system.

All the documentation is accessible at the press of a button, needless to say we are proud to be affiliated with you and with this level of professionalism.

Mrs. V. Donjeany
LEPRO Corporation CC, South Africa.


We have been using FlinkISO as our Quality Management software for the past year and we are extremely satisfied with the software and services offered.

The support team installed the software for us and worked with us to customize our Quality Management website which made the transition from a paper based system to an online one effortless.

They always respond promptly to any questions or inquiries and have processed our web customization requests with speed and reliability.

I would highly recommend their services.

Priyangi Perera
Pro-Lab Diagnostics, Round Rock, Texas.

Happy Customers!
across the globe

lepro pro-labs univida acekraft wello solidus honix htsi

India

Techmentis Global Services Pvt. Ltd.
D-502, Om Elegance-3 CHSL, Malad West, Mumbai 400065, MH, India.
+91 9820 567801 | [email protected]m

India

GK Consulting Delhi, India.
+91 9999 478640 | [email protected]

South Africa

Junto Group
Madison Square Offices No.1,5th Street, Northwold
+27 11 251 6300 | +21 76 264 9884