Record Management Requirements Sample Clauses

Record Management Requirements. Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan). 4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity. 4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results. 4.3. Record and document security systems shall be adequate to ensure confidentiality and proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC. 4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP. 4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site. 4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer. 4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request.

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Record Management Requirements. Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan). 4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results. 4.3. Record and document security systems shall be adequate to ensure confidentiality and privacy of proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC. 4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP. 4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site. 4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer. 4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request.

Record Management Requirements. Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan). 4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity. 4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results. 4.3. Record and document security systems shall be adequate to ensure confidentiality and privacy of proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC. 4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP. 4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site. 4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer. 4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request. 16 Reporting Monthly Reports Due by the 8th of each month during the performance of work efforts PDF or Word document * Days = Calendar days Attention: Xxxxxxx Xxxx, Vice President of Business Development and Marketing Subject: Modification No. 20 (a) SAIC Subcontract P010022290 Dear Mr. Lucy: In 2012, SAIC, Inc. announced plans to separate into two independent, publicly-traded companies. This separation was approved by the SAIC Board of Directors and will occur on 28 September 2013. The legacy company (SAIC, Inc.) will operate under the name Leidos, Inc., and will continue to use the original Home Office CAGE Code and DUNS Number. Therefore, this unilateral modification, effective 28 September 2013, to Reference (a) Subcontract is issued to amend “Science Applications International Corporation” (SAIC) to “Leidos, Inc.”. All references in the Reference (a) Subcontract to “SAIC” are h...

Record Management Requirements. Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan). 4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity. 4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results. 4.3. Record and document security systems shall be adequate to ensure confidentiality and privacy of proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP. 4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site. 4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer. 4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 16 Reporting Monthly Reports Due by the 8th of each month during the performance of work efforts PDF or Word document * Days = Calendar days [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Attention: Xxxxxxx Xxxx, Vice President of Business Development and Marketing Subject: Modification No. 20 (a) SAIC Subcontract P010022290 Dear...

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